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Biosimilars Deals 2021

Explore our interactive biosimilar news updates, collating tailored reports by brand, INN, originator/biosimilar applicant, litigation, region, or date. Alternatively, review our weekly BioBlast updates below.

Biocad Secures First Biosimilar to BMS’ Opdivo® (Nivolumab) Approved in Russia

On 21 July 2026, GxP News reported that Biocad has received marketing authorisation from Russia’s Ministry of Health for Nivocad®, biosimilar to BMS’ Opdivo® (nivolumab), for the treatment of various cancers.  This is the first biosimilar nivolumab to be approved in Russia.

Nivocad® is approved for the same indications as the reference product.  Nivolumab is included on Russia’s Vital and Essential Drugs list, which allows for increased accessibility for patients.

Zydus’ Tishtha™ was the first nivolumab biosimilar to be launched in the world when it became available in India in January 2026 (approved July 2024), following the High Court of Delhi’s 12 January 2026 reversal on appeal of a preliminary injunction granted to BMS in relation to the biosimilar.

Multiple nivolumab biosimilars are under development including Sandoz’s JPB898, Xbrane/Intas’ Xdivane™, Amgen’s ABP 206, Reliance Life Sciences’ RLS-Nivolumab, Enzene’s candidate, Boan Biotech’s BA1104, and NeuClone’s candidate.  Biosimilar developers are taking advantage of the reduced Phase 3 trial requirements globally, including Sandoz streamlining its biosimilar nivolumab clinical trials.

Patent Pending, Injunction Ending… The Federal Court Steps into the Ring

 

Date of decision: 2 June 2026
Body: Federal Court of Australia
Adjudicator:
Justice Stellios

Introduction

Justice Stellios, sitting as duty judge in the Federal Court of Australia, has granted a mandatory interlocutory injunction requiring RedTail Technology Pty Ltd (RedTail) and its founder and sole director, secretary and shareholder (Richard Pahlavani), to withdraw all patent applications that claim priority from Australian Patent Application number 2024904131 titled “LASER DIRECTOR, AN ELECTROMAGNETIC SPECTRUM DENIAL DEVICE, A POINTING SYSTEM AND A WEAPON SYSTEM”, including any applications filed under the Patent Cooperation Treaty.

The Applicants, EOS Space Systems Pty Limited and EOS Defence Systems Pty Limited (EOS), claim that making the patent applications amounted to misuse of information and other unlawful conduct by RedTail and Mr Pahlavani based on his previous employment by the Applicants.  The mandatory interlocutory injunction application was brought on an urgent basis, with the proceedings commenced on Friday 29 May 2026, the hearing of the application occurring on Monday 1 June 2026 and Justice Stellios delivering his decision on Tuesday 2 June 2026. The proceedings continue, with the case now in the hands of Justice Moore, with a case management hearing before Justice Moore scheduled for 6 August 2026.

Background

EOS is in the business of designing and manufacturing advanced technology systems including remote weapon systems, high energy laser weapons, AI-enabled command-and-control for layered counter-drone capability, and ground-based space control capabilities for precision tracking, intelligence and deterrence. EOS’ clients include defence and military forces around the world.

EOS had employed Mr Pahlavani as a laser engineer between January 2021 and March 2024. Mr Pahlavani’s employment contract with EOS contained confidential information and intellectual property clauses. While at EOS, Mr Pahlavani worked on a project relating to a laser system or anti-drone system (Laser Rifle).

Mr Pahlavani resigned from EOS in March 2024. He then incorporated RedTail in August 2024. In December 2024, RedTail filed a provisional patent application: Australian Patent Application number 2024904131 entitled “LASER DIRECTOR, AN ELECTROMAGNETIC SPECTRUM DENIAL DEVICE, A POINTING SYSTEM AND A WEAPON SYSTEM” (the 131 Application), with an application subsequently being filed under the Patent Cooperation Treaty (the PCT Application).

EOS alleged that Mr Pahlavani had used and/or disclosed, without permission, confidential information obtained from his employment with EOS in preparing these patent applications.

Key Issues

EOS filed these proceedings seeking orders permanently restraining Mr Pahlavani and RedTail from using/disclosing confidential information obtained from Mr Pahlavani’s employment with EOS (the Confidential Information), pecuniary relief, and delivery and destruction of the information.

EOS sought this relief on the basis that Mr Pahlavani had allegedly:

(1)    contravened s 183 of the Corporations Act 2001 (Cth);

(2)    breached an equitable obligation of confidentiality owed to EOS;

(3)    breached the terms of his employment contract with EOS; and

(4)    breached his fiduciary duty to EOS

EOS also alleged that RedTail had been knowingly involved in Mr Pahlavani’s contravention of s 183 of the Corporations Act, had breached an equitable obligation of confidentiality owed to EOS, had induced Mr Pahlavani’s breach of his employment contract, and had been knowingly involved in Mr Pahlavani’s breach of fiduciary duty to EOS.

Critically, EOS also sought an urgent mandatory interlocutory injunction requiring RedTail (and Mr Pahlavani) to withdraw all patent applications that claim priority from the 131 Application, including any applications filed under the Patent Cooperation Treaty. It is this mandatory interlocutory injunction application which was the subject of Justice Stellios’ decision.

Justice Stellios decided the mandatory interlocutory injunction application on the basis of the alleged contravention of s 183(1) of the Corporations Act. Section 183(1) provides that a person who obtains information because they are, or have been, a director or other officer or employee of a corporation must not improperly use the information to (a) gain an advantage for themselves or someone else or (b) cause detriment to the corporation.

Justice Stellios applied the undisputed principles applicable to interlocutory injunction applications in determining whether to grant the injunction, namely:

  • Whether there was a serious question to be tried;
  • Whether the balance of convenience favoured the making of the order; and
  • Whether damages would not be an adequate remedy.

In addition to these undisputed principles, Mr Pahlavani and RedTail submitted that the mandatory character of the interlocutory injunction (which required RedTail and Mr Pahlavani to perform a specific positive action i.e. to withdraw the patent applications) should be a factor that weighs heavily against the order being made. While Justice Stellios considered that the fact that the order sought required Mr Pahlavani and RedTail to take certain action was a factor to consider on the interlocutory application, his Honour also considered that the character of the order was akin to an order that would have restrained them from filing the patent applications if the order had been sought beforehand. Accordingly, the order sought could in substance be characterised as an order to refrain from prosecuting the patent applications.

Serious Question to be Tried

EOS succeeded in persuading Justice Stellios that there was a serious question to be tried in respect of the alleged contravention of s 183(1) of the Corporations Act. His Honour considered that the uncontested expert evidence filed by EOS established that concepts that formed part of the EOS project on the Laser Rifle (to which Mr Pahlavani contributed and in relation to which he had access) were concepts forming part of the PCT Application. This led to the conclusion that there was a serious question to be tried as to whether Mr Pahlavani improperly used information obtained because he was an EOS employee to gain an advantage for himself and for RedTail.

In reaching this conclusion, Justice Stellios rejected the following arguments from Mr Pahlavani and RedTail:

  • That EOS had not specifically identified the information alleged to be confidential. His Honour disagreed, finding that the confidential information had been specifically identified, with his Honour’s view being strengthened by the fact that Mr Pahlavani had been able to “engage” with the alleged confidential information allegations.
  • That the alleged confidential information was not in fact confidential. His Honour considered that the position was not presently clear on the evidence before him and, so, it did not displace the existence of a serious question to be tried. Further, his Honour noted that s 183(1) of the Corporations Act required consideration of whether Mr Pahlavani and RedTail had improperly used information (not confidential information).
  • That EOS’ actions had given rise to an estoppel on the basis that Mr Pahlavani had allegedly disclosed that he had a pre-existing project to EOS and EOS had agreed that he could continue to own and develop the technology the subject of that pre-existing project. His Honour considered that the possibility of an estoppel argument was insufficiently clear to undermine the fact that there was a serious question to be tried.

Balance of Convenience

EOS then went on to successfully persuade his Honour that the balance of convenience favoured the grant of the mandatory interlocutory injunction.

EOS argued that:

  • If allowed to proceed, the PCT Application and the 131 Application would become public on or about 18 June 2026, so destroying the confidentiality of the information. This would impact EOS’ ability to commercialise its product (particularly given the nature of their customer base, being defence and government organisations which mandate strict confidentiality protocols), leading to lost future sales and significant waste of invested resources. Competitors would also potentially be able to reverse-engineer or replicate the technology.
  • Even if EOS was entitled to be assigned any patent arising from the PCT Application, that would not address the harm identified above. Justice Stellios considered that this factor and the previous factor weighed heavily in EOS’ favour.
  • EOS accepted that they might need to give an undertaking as to damages which would protect RedTail’s and Mr Pahlavani’s position.  In contrast, RedTail and Mr Pahlavani did not have the means to meet an adverse pecuniary relief order. This meant that, even if damages were an adequate remedy, there would likely be no compensation flowing to EOS. Justice Stellios accepted this submission.

In answer to EOS’s position, RedTail and Mr Pahlavani argued that:

  • They would suffer material prejudice, in particular that the injunction sought would put an end to the current patent applications. This would result in a lost opportunity to seek patent protection in multiple jurisdictions on the basis of the current priority date, and consequent financial loss for RedTail and Mr Pahlavani given the investment made in the patent applications. RedTail and Mr Pahlavani would also be unable to obtain outside investment in RedTail’s business because investors would be unwilling to invest in a product without patent protection. Further, EOS’ proffered undertaking would be insufficient to adequately address that prejudice, and damages would not be an adequate remedy. While his Honour accepted that RedTail and Mr Pahlavani would suffer the detriment outlined above and that there might be some challenges for any assessment of damages, Justice Stellios was not persuaded that the lost opportunity from the forced withdrawal of the patent applications was not compensable in the ordinary way. His Honour noted that EOS had offered the usual undertaking, and that it was uncontested that they had the financial means to satisfy an award for damages.
  • EOS had delayed bringing its application for a mandatory interlocutory injunction. While his Honour accepted that there had been some delay, Justice Stellios did not consider this delay to be disentitling.
  • EOS had approached the Court with unclean hands, including because of the matters that formed the basis of the estoppel claim. His Honour did not give weight to this argument.
  • There was no serious question to be tried. For the reasons set out above, his Honour did not give weight to this argument.
  • There was an alternative mechanism suggested to EOS, of seeking the redaction of passages from the PCT Application. RedTail’s and Mr Pahlavani’s counsel, however, conceded during the hearing that there would be no guarantee that such an option would be effective.

Outcome and Implications

Accordingly, Justice Stellios granted the mandatory interlocutory injunction, subject to EOS providing the usual undertaking as to damages. The 131 Application has now been withdrawn, with its status showing as “lapsed” on the Australian patents register.

Justice Stellios’ decision will be welcome news for employers for whom enforcement of confidentiality obligations owed by former employees is critical. His Honour’s decision continues the recent run of interlocutory injunction cases heard by the Federal Court of Australia in the context of patent disputes, albeit the fundamental dispute here related to an alleged misuse of confidential information. Justice Stellios’ decision illustrates the swiftness with which the Federal Court can hear and determine interlocutory injunction applications. Justice Stellios’ decision also illustrates the Federal Court’s willingness to grant an interlocutory injunction where the facts justify the grant of the injunction, even when, as in this case, the enjoined party loses the opportunity to pursue a valuable property (patent) right as a result.


 

About Pearce IP

Pearce IP is a privately owned/independent, specialist, life-sciences focussed, intellectual property/law firm offering lawyers and attorneys in Australia and New Zealand.

Our lawyers and attorneys specialise in pharma, biopharma, biotech, ag-tech, food-tech, med-tech, although our work is broader than these industries.

Pearce IP and its leaders are ranked in every notable legal directory including: Chambers & Partners, Legal 500, IAM Patent 1000, IAM Strategy 300, MIP IP Stars, Doyles Guide, WTR 1000, Best Lawyers, WIPR Leaders, Best Law Firms, among others. In 2025, Pearce IP was honoured by Australasian Lawyer and New Zealand Lawyer as a Top Specialist Firm, 5 Star Employer of Choice, and the “Standout Winner” for Inclusion and Culture (<100 employees).  

Pearce IP is the only leading IP firm in Australia and New Zealand with a female founder, and is certified by WEConnect International as women owned.

 

Naomi Pearce

Naomi Pearce

CEO, Executive Lawyer (AU, NZ), Patent & Trade Mark Attorney (Trans Tasman)

Naomi is the CEO and Founder of Pearce IP, and is one of ANZ’s leading IP practitioners. Naomi is a market leading, strategic, commercially astute, patent lawyer, patent attorney and trade mark attorney, with over 29 years’ experience, and a background in molecular biology/biochemistry.

Ranked in virtually every notable legal directory, highly regarded by peers and clients, Naomi is renowned for her successful and elegant IP/legal strategies focussing on complex/multijurisdictional litigation, global FTO, and strategic advice.  Among other awards, Naomi is the 2026 Lexology Client Choice Winner for Patents, the 2024 Lawyers Weekly Women in LawExecutive of the Year”, the 2023 Lawyers Weekly “IP Partner of the Year”, the 2022 Lexology Client Choice Winner for Life Sciences, the 2022 Asia Pacific Women in Business Law Patent Lawyer of the Year”, and the 2021 Lawyers Weekly Women in Law “Partner of the Year”.  Ranked in Chambers Asia Pacific, Chambers Global,  IAM Patent 1000IAM Strategy 300, is a MIP “Patent Star”, and is recognised as a WIPR Leader for patents and trade marks.

Pearce IP is the premier life sciences focussed firm in ANZ.  Commencing in 2017. Pearce IP is the 2025 Australasian Lawyer and NZ Lawyer 5-Star Employer of Choice & “Standout Winner” for Inclusion and Culture (<100 employees).  In 2021, Pearce IP was the Lawyers Weekly Australian Law Awards IP Team of the Year.

Paul Johns

Paul Johns

Executive, Lawyer (Head of Litigation – New Zealand)

Paul is an intellectual property dispute resolution specialist with more than 24 years of experience across New Zealand and the UK. Paul is a seasoned lawyer, IP strategist, and Head of Pearce IP’s litigation team in New Zealand.  Paul appears in cases before the New Zealand Court of Appeal and High Court of New Zealand, as well as the New Zealand Intellectual Property Office and IP Australia

Paul is experienced in managing contentious disputes regarding all types of intellectual property and related issues, including patents, copyright, trade marks, designs, confidential information and consumer law. With a background in molecular genetics, Paul has acted for clients across a vast range of industries, including pharmaceuticals, biotechnology, animal health, med-tech, food & beverage technologies, heavy vehicle engineering, fashion, hospitality, and entertainment. Paul is recommended for litigation in the IAM Patent 1000, rated for enforcement and litigation in the WTR1000, ranked for Intellectual Property Asia-Pacific in Chambers, and recognised for Intellectual Property and Litigation in Best Lawyers.

Helen Macpherson

Helen Macpherson

Executive, Lawyer (Head of Litigation –Australia)

Helen is a highly regarded intellectual property specialist and industry leader with more than 25 years’ experience advising on patents, plant breeder’s rights, trade marks, copyright and confidential information. She is known for her expertise in complex, high-value patent matters and leverages her technical background in biochemistry and molecular biology to work across a wide range of technologies, including inorganic, organic, physical and process chemistry, biochemistry, biotechnology (including genetics, molecular biology and virology), and physics. Helen is an active member of the Intellectual Property Committee of the Law Council of Australia and the Intellectual Property Society of Australia and New Zealand.

Samsung Biologics to Acquire PolyPeptide Group in CHF 1.46B Deal

On 20 July 2026, Samsung Biologics announced that it has entered into an all-cash public tender to acquire 100% of PolyPeptide Group AG, a leading Swiss-based global contract development and manufacturing organisation (CDMO), specialised in peptide-based active pharmaceutical ingredients.

Under the terms of the tender offer, PolyPeptide Group shareholders will receive CHF 44.31 in cash per share.  The transaction is expected to close at the end of 2026, subject to regulatory approvals and closing conditions.

This acquisition will allow Samsung Biologics to leverage PolyPeptide Group’s peptide-based capabilities and expand its current CDMO offerings beyond antibodies and ADCs, addressing growing demand for peptide-based therapeutics, particularly in obesity and diabetes, including GLP-1 therapies.

Following the November 2025 spin-off of biosimilar operations into a new holding entity, Samsung Epis Holdings, Samsung Biologics has focused on its contract development and manufacturing business.

Novo Nordisk Sues Cipla for Patent Infringement and Eli Lilly for False Advertising in US Regarding Ozempic®/Wegovy® (Semaglutide)

Novo Nordisk has commenced Hatch-Waxman litigation in the US against both Cipla and Apotex in relation to their generic versions of Novo Nordisk’s semaglutide products.

Most recently, on 17 July 2026, Novo Nordisk filed a Complaint against Cipla in the US District Court for the District of New Jersey alleging that Cipla’s generic version of Novo Nordisk’s Ozempic® (semaglutide) infringes four US patents which cover Ozempic® and/or its use: US 8,129,343, US 10,335,462, US 12,295,988 and US 12,569,543.  The complaint arises from Cipla’s submission of an Abbreviated New Drug Application (ANDA) seeking approval to market generic Ozempic® in dosage strengths of 2 mg/3ml, 4 mg/3ml and 8 mg/3ml.

Novo Nordisk had previously commenced litigation in the same Court against Apotex on 10 October 2024 in relation to generic Rybelsus® (semaglutide), on 20 February 2026 in relation to generic Ozempic® tablets® and on 29 April 2026 in relation to generic Wegovy® (semaglutide).  Orders were made by the Court on 12 June 2026 consolidating the three actions.  Apotex received the first US FDA Tentative Approval for its generic Ozempic® ANDA in April 2026, signifying that Apotex’s product meets all statutory and regulatory requirements for approval but cannot be marketed in the US because of patents or exclusivities related to the reference drug.

Novo Nordisk also has patent litigation pending in the US District Court for the District of Delaware against each of Sun Pharmaceutical and Mylan in relation to generic Wegovy®, which was commenced in September 2024.

Meanwhile, on 21 July 2026, Novo Nordisk filed a false advertising lawsuit against Eli Lilly in the US District Court for the District of New Jersey, alleging that Eli Lilly’s nationwide, direct-to-consumer advertising campaigns for GLP-1 medicines are designed to mislead the public about the comparative effects of those medicines for weight loss and type 2 diabetes.

Novo Nordisk claims that Eli Lilly’s ads falsely tell consumers that Zepbound® (tirzepatide) helps patients lose significantly more weight than Novo Nordisk’s Wegovy® and that Eli Lilly’s Mounjaro® (tirzepatide) reduces a key measure of blood sugar control for type 2 diabetes patients significantly more than Novo Nordisk’s Ozempic®.  According to Novo Nordisk, in both cases, the ads are false and misleading because Eli Lilly seeks to support its representations with outdated clinical trials that compare the highest dose of Zepbound®/Mounjaro® to lower doses of Novo Nordisk’s medicines, when there are newer, more effective does of Novo Nordisk’s products available.

Novo Nordisk is seeking preliminary and permanent injunctions preventing Eli Lilly from continuing to disseminate the comparative advertising, as well as damages and corrective advertising.

Organon & Samsung Bioepis Expand Biosimilar Development and Commercialisation Agreement in Australia

On 16 July 2026, Organon and Samsung Bioepis announced the expansion of their development and commercialisation agreement for Australia, to include a new biosimilar.  While the biosimilar has not been named by Organon or Samsung Bioepis, Pharma in Focus has suggested that it may be Epyztek®, biosimilar to J&J’s Stelara® (ustekinumab).

Under the terms of the expanded agreement, Organon will obtain the exclusive Australian commercialisation rights to the biosimilar, while Samsung Bioepis will maintain full development, manufacturing and regulatory responsibilities.

Samsung Bioepis’ Epyztek® (ustekinumab) was approved in Australia in October 2024 and was recommended for PBS-listing at PBAC’s March 2025 meeting.  The drug has not yet been PBS-listed pending lodgement of required documentation.

In October 2025, Samsung Bioepis successfully opposed Janssen’s Australian patent application (AU2019346134) relating to a method of treating ulcerative colitis (UC) with Stelara® (ustekinumab).

This followed a decision of the Federal Court of Australia in June 2025, ordering that three Janssen Biotech innovation patents be revoked (AU2024100006, AU2024100007 and AU2024100016).  In an earlier victory for Samsung Bioepis, Janssen surrendered two innovation patents (AU 2023100041 and 2023100042), which related to methods of treating UC with ustekinumab.

Organon is currently sponsoring three of Samsung Bioepis’ biosimilars in Australia under the existing agreement: Brenzys® (etanercept), which was TGA-approved July 2016 and PBS-listed July April 2017; Renflexis® (infliximab), TGA-approved November 2016 and PBS-listed August 2017; and Hadlima® (adalimumab), TGA-approved in January 2018, launched March 2021 and PBS-listed in April 2021.

In June 2026, the companies announced the expansion of their Canadian collaboration, first established in 2013, from five to six biosimilars to include Pyzchiva®, biosimilar to J&J’s Stelara (ustekinumab).

Shanghai Henlius Doses First Patient in China in Ph 1 Trial for Biosimilar to BMS’ Opdivo® (Nivolumab)

On 16 July 2026, Shanghai Henlius Biotech announced that the first patient in China has been dosed in its international multicentre Phase 1 clinical trial of HLX18, biosimilar to BMS’ Opdivo® (nivolumab).

Henlius received approval from China’s National Medical Products Administration for the investigational new drug (IND) application for HLX18 in March 2026.  This followed FDA approval of the HLX18 IND application in December 2025.

The Phase 1 study, initiated in June 2026, is designed to evaluate the similarity in pharmacokinetic profile, efficacy, safety and immunogenicity of HLX18 and BMS’ Opdivo® in patients with resected oesophageal or gastroesophageal junction cancer, melanoma or urothelial carcinoma.  Primary completion of the study is expected in August 2027.

Nivolumab biosimilars are under development including Sandoz’s JPB898Xbrane/Intas’ Xdivane™Amgen’s ABP 206Reliance Life Sciences’ RLS-NivolumabEnzene’s candidateBoan Biotech’s BA1104NeuClone’s candidate and Zydus’ ZRCr-4276.  In June 2026, Orion Pharma announced it entered into an agreement with Shilpa Biologicals for the European commercialisation of Shilpa’s intravenous nivolumab biosimilar, which is currently under development.

Zydus’ Tishtha™ was the first nivolumab biosimilar to be launched in the world when it became available in India in January 2026 (approved July 2024), following the High Court of Delhi’s 12 January 2026 reversal on appeal of a preliminary injunction granted to BMS in relation to the biosimilar.

Sun Pharma’s Generic Semaglutide Approved & Novo Nordisk to Launch Low-Cost Ozempic® in South Africa

On 15 July 2026, Sun Pharma announced that the South African Health Products Regulatory Authority (SAHPRA) has approved its semaglutide injection, generic equivalent of Novo Nordisk’s Ozempic® (semaglutide) for the treatment of adults with type 2 diabetes mellitus.  The launch is expected to occur in the coming days.

The semaglutide injection was approved as a pre-filled, multi-dose injectable pen in two strengths (2 mg/1.5 mL and 4 mg/3 mL) for once-weekly treatment of adult patients as an adjunct to diet and exercise.  This is the second market to date, following India, where Sun Pharma’s generic semaglutide has received approval.

On 18 July 2026, Business Insider Africa announced that Novo Nordisk is partnering with Swiss pharmaceutical company, Acino, to launch Extensior™, a lower-cost version of Ozempic® (semaglutide) on 27 July 2026 in South Africa.  Extensior™ will be available in 0.25mg, 0.5mg and 1mg doses in the same injection device as Ozempic®.  This followed Novo Nordisk securing an interim order from the Gauteng High Court preventing iDexis from manufacturing and selling compounded semaglutide medicines in South Africa in June 2026.  iDexis has appealed the court order and decisions made by SAHPRA and the South African Pharmacy Council.

A number of generic semaglutide products have already launched in India and Canada.  In March 2026, Dr Reddy’s, Zydus, Alkem, Sun Pharma and Glenmark launched generic semaglutide products on the Indian market, following the expiry of Novo Nordisk’s core Indian patent for semaglutide.  Generic semaglutide products were launched in Canada in May 2026 by Apotex and Dr Reddy’s.  Apotex received the first US FDA Tentative Approval for its generic semaglutide ANDA in April 2026, giving it an opportunity to be one of the first to launch generic Ozempic® in the US following expiry of Novo Nordisk’s exclusivity/patents.

Novo Nordisk has recently launched alternative semaglutide formulations globally.  Novo Nordisk’s Wegovy® pill was the first oral GLP-1 treatment recommended for approval by CHMP for weight management in the EU.  Marketing authorisation for the Wegovy® pill and Wegovy® 7.2mg injection in a single-dose pen was granted by the European Commission on 15 July 2026.  This followed the first-in-world US approval of the oral formulation by the FDA on 23 December 2025 and US launch of the Wegovy® pill on 5 January 2026.

Celltrion Secures Korean Approval for Phase 1 Trial for Biosimilar to Janssen’s Tremfya® (Guselkumab)

On 15 July 2026, Celltrion announced that South Korea’s Ministry of Food and Drug Safety (MFDS) has approved its investigational new drug application to commence a Phase 1 clinical trial of CT-P68, biosimilar to Janssen’s Tremfya® (guselkumab).

The Phase 1 trial will assess the safety and pharmacokinetic equivalence of CT-P68 and Tremfya® in 258 healthy adults.

No guselkumab biosimilars have yet been approved in any major market.  Guselkumab biosimilars are being developed by Polpharma Biologics, whose PB019 is licensed to MS Pharma in the MENA region, and Samsung Bioepis.  Alvotech also has a proposed guselkumab biosimilar in development, partnered with Advanz Pharma for commercialisation in the EU, UK and Switzerland.

Dead on Arrival – The Full Court Jumpstarts a Best Method Nightmare for Divisional Patentees

 

Date of decision: 10 April 2026
Body: Full Court of the Federal Court of Australia
Adjudicator:
Beach, Downes and Jackman JJ

Introduction

On 10 April 2026, the Full Court of the Federal Court of Australia delivered its decision in NOCO’s appeal from the primary judge’s decision in The NOCO Company v Brown and Watson International Pty Ltd [2025] FCA 887.  Our article on the primary judge’s decision is available here.

The Full Court dismissed NOCO’s appeal, rejecting NOCO’s challenges on obviousness and the correct priority date for assessing novelty.  Notably, however, the Full Court overturned the primary judge’s decision that the relevant date for assessing NOCO’s knowledge of the best method of performing the claimed inventions was the filing date of the priority document and not the later filing dates of each of the divisional applications containing the complete specifications for the patents in suit.  As a result, the Full Court assessed the best method ground at these later dates, finding that the specification for each of the patents did not disclose the best method known to NOCO of performing the invention.

Background

The case concerned three Australian patents held by NOCO, relating to portable vehicle battery jump starter apparatus with safety protection:

All three patents were from the same family, each claiming priority from PCT/US2014/045434 (PCT 434) filed on 3 July 2014 (the Asserted Priority Date).

The patents addressed safety problems with traditional jump starter devices, where jumper cables could accidentally contact each other or be connected with reverse polarity, causing sparking and potential injury.  The patented solution involved a control system that detected both battery presence and correct polarity before allowing a power switch to connect the internal battery to the external vehicle battery.

Although many claims were in issue, considerable attention was given to Claim 1 of the 223 Patent, which claims as follows (following the Court’s added integer sub-numbering):

1.1A jump starter apparatus for boosting or charging a depleted or discharged battery having a positive battery terminal and a negative battery terminal, the apparatus comprising:
1.2a power supply;
1.3a positive battery connector for connecting the jump starter apparatus to the positive battery terminal of the depleted or discharged battery;
1.4a negative battery connector for connecting the jump starter apparatus to the negative battery terminal of the depleted or discharged battery;
1.5a power switch connected in circuit with the power supply and the positive and negative battery connectors, the power switch configured to turn power on or off from the power supply to the positive and negative battery connectors;
1.6a control system or circuit connected to and controlling the power switch, the control system or circuit configured to detect presence of the depleted or discharged battery when connected between the positive and negative battery connectors and to detect polarity of the depleted or discharged battery when connected between the positive and negative battery connectors;
1.7wherein the control system or circuit switches on the power switch to connect the power supply to the depleted or discharged battery only when (1.7.1) the depleted or discharged battery is present and properly connected between the positive and negative battery connectors and (1.7.2) the depleted or discharged battery is properly connected with a correct polarity between the positive and negative battery terminals.

NOCO brought proceedings against B&W, alleging infringement of the patents by B&W’s ‘Projecta’ brand jump starters.  B&W cross-claimed, seeking to invalidate all asserted claims on grounds of lack of novelty, lack of inventive step, failure to disclose the best method, lack of support, insufficiency and lack of utility.

The lack of novelty ground depended largely on whether the three patents were entitled to the Asserted Priority Date of 3 July 2014.  The primary judge found that many of the asserted claims were not entitled to the Asserted Priority Date, and, given NOCO’s concession that claims not entitled to the Asserted Priority Date would be invalid for lack of novelty, these claims failed on that basis.  The primary judge found that all of the asserted claims were invalid for lack of inventive step, but concluded that the best method ground was not made out.  It was not necessary for the primary judge to consider the remaining grounds of invalidity.

Key Issues on Appeal

Lack of Inventive Step

The Full Court rejected all of NOCO’s grounds of appeal challenging the primary judge’s decision that all of the Asserted Claims were invalid for lack of inventive step.  In rejecting NOCO’s challenge to the primary judge’s findings, the Court stated (amongst other things) that:

  • The expert evidence established that the primary judge’s observation that inclusion of the arrangement in integers 1.6 and 1.7 in a jump starter device would have been a matter of routine involved an acceptance that there was a known problem, with a known solution, and the skilled person would choose and apply that solution without any difficulty in a jump starter having all the features of Claim 1 of the 223 Patent.
  • The primary judge did not fail to assess obviousness using the skilled team as a whole.  The primary judge combined the common general knowledge of each of the product designer and the electrical engineer comprising the notional team when concluding that the invention was obvious.
  • The primary judge was clearly alive to the issue of hindsight, and was satisfied that the expert evidence was not tainted or otherwise affected by any hindsight.
  • An invention may be obvious even if there are numerous other obvious routes as well.  It is therefore not a requirement to find that a skilled person would be motivated to follow a single path and no others.
  • When considering whether an invention is obvious in light of the common general knowledge plus a prior art document (under section 7(3) of the Patents Act), it is sufficient if the prior art document adds to the common general knowledge something that renders the claimed invention obvious in any relevant way.  Further, the question is not whether the prior art document would have led directly, and as a matter of routine, to the claimed invention, as that is not the question to which section 7(3) of the Act is directed.  Section 7(3) directs attention to the combination of information in the common general knowledge and the s 7(3) document.  And, the fact that a witness has reservations in respect of certain aspects of a document does not, without more, lead inevitably to the consequence that the skilled person would entirely disregard the document.

Priority Date

The Full Court also rejected all of NOCO’s grounds of appeal challenging the primary judge’s decision that none of the asserted claims were entitled to the Asserted Priority Date.  As a result, these claims lacked novelty as NOCO had conceded that claims not entitled to the Asserted Priority Date would be invalid for lack of novelty.

The Full Court agreed with the primary judge that the following two essential features in the priority document (PCT 434) were missing from the asserted claims:

  • The use of a FET switch which was consistently identified as essential (not merely illustrative) throughout PCT 434.  PCT 434 also did not disclose the possibility that other types of power switches, such as electromagnetic switches, might be used.  In contrast, the asserted claims encompassed the use of any type of power switch.
  • The use of two sensors to detect presence and polarity respectively which was consistently identified as essential in PCT 434.  In contrast, the asserted claims included claims which did not require the use of two sensors.

Accordingly, the invention claimed in each of the asserted claims was not disclosed in PCT 434, and so was not entitled to claim priority from PCT 434.

Best Method

At first instance, the primary judge had found that the relevant date for assessing NOCO’s knowledge of the best method of performing the claimed inventions was the filing date of PCT 434 (i.e. 3 July 2014), and not the later filing dates of each of the divisional applications containing the complete specifications for the Patents (being dates in 2020 to 2022).  If the relevant date was the date of filing PCT 434, this ground of invalidity failed.  However, if the relevant date was the filing date of each of the divisional applications containing the complete specifications for the Patents, then there was a factual issue as to whether NOCO was aware of a better method of performing the invention in 2020 to 2022 than that which was disclosed in each of the patents.

The Full Court overturned the primary judge’s decision on this point, finding that the language of the relevant statutory provisions and the previous judicial decisions supported the conclusion that the relevant date for ascertaining the patentee’s knowledge of the best method is the date of filing the complete specification for the patent in suit, not the earlier date of a PCT specification.

The Full Court also considered that to use such a time of filing did not create any unjustifiable asymmetrical burden on NOCO for the following reasons:

  • NOCO had, through the divisional applications, claimed an enlarged monopoly in comparison to that claimed in PCT 434.
  • The relevant claims in PCT 434 were limited to a jump starter with a FET switch and two sensors.  However, NOCO had discovered that such a switch was unreliable and removed that limitation from the relevant claims in the specifications in the divisional applications without disclosing that a different switch ought to be used.
  • Accordingly, it was appropriate that NOCO be required to make a disclosure corresponding to the enlarged monopoly claimed in the divisional applications.  Not to require such disclosure at the later time would be contrary to the policy underpinning the best method requirement and would allow NOCO to withhold knowledge of the best method known at that later time.

As a result, the Full Court held that the specification for each of the patents did not disclose the best method known to NOCO of performing the invention.

Outcome and Implications

Accordingly, the Full Court dismissed NOCO’s appeal and ordered that NOCO pay B&W’s costs of the appeal.  The Full Court’s decision provides valuable guidance on the test and relevant evidence for lack of inventive step, as well as the correct approach to determining whether a patent is entitled to a priority date earlier than its filing date.  Most importantly, the Full Court has confirmed that the relevant date for assessing a patentee’s knowledge of the best method of performing the claimed inventions is not the filing date of the priority document but is instead the later filing dates of each of the divisional applications containing the complete specifications for the patents in suit.  Patent attorneys will need to be cautious when recommending a divisional filing strategy to ensure that applicant clients are aware that they may have an obligation to update their disclosures of best method (if a better method has been developed in the intervening time period).


 

About Pearce IP

Pearce IP is a privately owned/independent, specialist, life-sciences focussed, intellectual property/law firm offering lawyers and attorneys in Australia and New Zealand.

Our lawyers and attorneys specialise in pharma, biopharma, biotech, ag-tech, food-tech, med-tech, although our work is broader than these industries.

Pearce IP and its leaders are ranked in every notable legal directory including: Chambers & Partners, Legal 500, IAM Patent 1000, IAM Strategy 300, MIP IP Stars, Doyles Guide, WTR 1000, Best Lawyers, WIPR Leaders, Best Law Firms, among others. In 2025, Pearce IP was honoured by Australasian Lawyer and New Zealand Lawyer as a Top Specialist Firm, 5 Star Employer of Choice, and the “Standout Winner” for Inclusion and Culture (<100 employees).  

Pearce IP is the only leading IP firm in Australia and New Zealand with a female founder, and is certified by WEConnect International as women owned.

 

Helen Macpherson

Helen Macpherson

Executive, Lawyer (Head of Litigation –Australia)

Helen is a highly regarded intellectual property specialist and industry leader with more than 25 years’ experience advising on patents, plant breeder’s rights, trade marks, copyright and confidential information. She is known for her expertise in complex, high-value patent matters and leverages her technical background in biochemistry and molecular biology to work across a wide range of technologies, including inorganic, organic, physical and process chemistry, biochemistry, biotechnology (including genetics, molecular biology and virology), and physics. Helen is an active member of the Intellectual Property Committee of the Law Council of Australia and the Intellectual Property Society of Australia and New Zealand.

Paul Johns

Paul Johns

Executive, Lawyer (Head of Litigation – New Zealand)

Paul is an intellectual property dispute resolution specialist with more than 24 years of experience across New Zealand and the UK. Paul is a seasoned lawyer, IP strategist, and Head of Pearce IP’s litigation team in New Zealand.  Paul appears in cases before the New Zealand Court of Appeal and High Court of New Zealand, as well as the New Zealand Intellectual Property Office and IP Australia

Paul is experienced in managing contentious disputes regarding all types of intellectual property and related issues, including patents, copyright, trade marks, designs, confidential information and consumer law. With a background in molecular genetics, Paul has acted for clients across a vast range of industries, including pharmaceuticals, biotechnology, animal health, med-tech, food & beverage technologies, heavy vehicle engineering, fashion, hospitality, and entertainment. Paul is recommended for litigation in the IAM Patent 1000, rated for enforcement and litigation in the WTR1000, ranked for Intellectual Property Asia-Pacific in Chambers, and recognised for Intellectual Property and Litigation in Best Lawyers.

Sally Paterson

Sally Paterson

Executive, Lawyer (NZ), Patent & Trade Mark Attorney (AU, NZ)

Sally is a senior Trans-Tasman Patent and Trade Mark Attorney, and a New Zealand registered lawyer with over 20 years’ experience in IP.  Sally’s particular expertise is in life sciences, drawing from her background in biological sciences. Sally is well respected in the New Zealand IP community for her broad ranging skills in all aspects of intellectual property advice, protection and enforcement. Sally has extensive experience securing registration for patents, designs and trade marks in New Zealand, Australia and internationally, providing strategic infringement, validity and enforceability opinions, acting in contentious disputes including matters before the courts of New Zealand and before IPONZ and IP Australia, and advising on copyright and consumer law matters.

Pearce IP BioBlast® for the week ending 10 July 2026

Pearce IP provides weekly reports on global biosimilars activities in the Pearce IP BioBlast®. Significant biosimilar activities for the week ending 10 July 2026 are set out below:


Aflibercept

On 8 July 2026, Teva and Samsung Bioepis announced that they have entered an agreement for the commercialisation in Canada of Opuviz®/SB15 (aflibercept)… Read more here.

Bevacizumab

On 7 July 2026, Celltrion announced that it has successfully secured formulary listings for Vegzelma™, biosimilar to Roche/Genentech’s Avastin® (bevacizumab)… Read more here.

Cetuximab

On 8 July 2026, Shanghai Henlius Biotech announced that the first patient in China has been dosed in its multicentre Phase 1 clinical trial of HLX05-N, biosimilar to… Read more here.

Ocrelizumab

9 July 2026 | Teva Inks Licensing Deal with Polpharma Biologics for Biosimilar to Roche’s Ocrevus® (Ocrelizumab)
On 9 July 2026, Teva and Polpharma Biologics announced that they entered into an exclusive licensing agreement for the commercialisation of intravenous and… Read more here.

Pegfilgrastim

9 July 2026 | US | Accord BioPharma’s Biosimilar to Amgen’s Neulasta® (Pegfilgrastim) Approved in US
On 9 July 2026, PR Newswire reported that the FDA has approved Accord BioPharma’s Ennumo™, biosimilar to Amgen’s Neulasta® (pegfilgrastim), for all approved… Read more here.


Pembrolizumab

6 July 2026 | US | Celltrion Streamlines Ph 3 Global Trial for Biosimilar to MSD’s Keytruda® (Pembrolizumab)
On 6 July 2026, Seoul Economic Daily reported that Celltrion has filed with the FDA an amendment to its global Phase 3 clinical trial plan for CT-P51, biosimilar to MSD’s… Read more here.

Pembrolizumab, Isatuximab

10 July 2026 | US | FDA Approves Expanded Indication for MSD’s Keytruda®/Keytruda Qlex™ (Pembrolizumab) & SC Form of Sanofi’s Sarclisa® (Isatuximab)
On 10 July 2026, the FDA announced that it approved each of MSD’s Keytruda® (pembrolizumab) and Keytruda Qlex™ (pembrolizumab and berahyaluronidase… Read more here.

Biopharma Deals

On 6 July 2026, Novartis and Myricx Bio announced that they have entered into an agreement for the acquisition of Myricx Bio by Novartis.  Myricx Bio is a UK-based… Read more here.
 
On 2 July 2026, Singaporean-headquartered Prestige Biopharma announced that it had signed a memorandum of understanding (MOU) with US-based Charles River… Read more here.

 

About Pearce IP

Pearce IP is a privately owned/independent, specialist, life-sciences focussed, intellectual property/law firm offering lawyers and attorneys in Australia and New Zealand.

Our lawyers and attorneys specialise in pharma, biopharma, biotech, ag-tech, food-tech, med-tech, although our work is broader than these industries.

Pearce IP and its leaders are ranked in every notable legal directory including: Chambers & Partners, Legal 500, IAM Patent 1000, IAM Strategy 300, MIP IP Stars, Doyles Guide, WTR 1000, Best Lawyers, WIPR Leaders, Best Law Firms, among others. In 2025, Pearce IP was honoured by Australasian Lawyer and New Zealand Lawyer as a Top Specialist Firm, 5 Star Employer of Choice, and the “Standout Winner” for Inclusion and Culture (<100 employees).  

Pearce IP is the only leading IP firm in Australia and New Zealand with a female founder, and is certified by WEConnect International as women owned.

 

Naomi Pearce

Naomi Pearce

CEO, Executive Lawyer (AU, NZ), Patent & Trade Mark Attorney (Trans Tasman)

Naomi is the CEO and Founder of Pearce IP, and is one of ANZ’s leading IP practitioners. Naomi is a market leading, strategic, commercially astute, patent lawyer, patent attorney and trade mark attorney, with over 29 years’ experience, and a background in molecular biology/biochemistry.

Ranked in virtually every notable legal directory, highly regarded by peers and clients, Naomi is renowned for her successful and elegant IP/legal strategies focussing on complex/multijurisdictional litigation, global FTO, and strategic advice.  Among other awards, Naomi is the 2026 Lexology Client Choice Winner for Patents, the 2024 Lawyers Weekly Women in LawExecutive of the Year”, the 2023 Lawyers Weekly “IP Partner of the Year”, the 2022 Lexology Client Choice Winner for Life Sciences, the 2022 Asia Pacific Women in Business Law Patent Lawyer of the Year”, and the 2021 Lawyers Weekly Women in Law “Partner of the Year”.  Ranked in Chambers Asia Pacific, Chambers Global,  IAM Patent 1000IAM Strategy 300, is a MIP “Patent Star”, and is recognised as a WIPR Leader for patents and trade marks.

Pearce IP is the premier life sciences focussed firm in ANZ.  Commencing in 2017. Pearce IP is the 2025 Australasian Lawyer and NZ Lawyer 5-Star Employer of Choice & “Standout Winner” for Inclusion and Culture (<100 employees).  In 2021, Pearce IP was the Lawyers Weekly Australian Law Awards IP Team of the Year.

Chantal Savage

Chantal Savage

Special Counsel, Lawyer

Chantal is an intellectual property disputes lawyer with experience advising across the spectrum of IP rights, including patents, trade marks, copyright, plant breeder’s rights and trade secrets/confidential information. Recognised as a Rising Star in IP by the Legal 500 Asia Pacific (2021-2024), Chantal has previously worked for international and top tier law firms in Australia and the United Kingdom.

With a science degree specialising in molecular biology and biochemistry, Chantal’s practice focuses particularly on complex, high-value, multi-jurisdictional patent infringement and revocation proceedings for clients in the life sciences sectors.

Maliha Hoque

Maliha Hoque

Paralegal

Maliha is a Paralegal and contributing author to Pearce IP’s flagship circulars BioBlast® and BioGxPulse®.  She is currently completing her Juris Doctor at the University of Sydney.  With a background in medical science, finance and risk consulting, and an inquisitive mind, Maliha loves leaving ‘no stone unturned’ when investigating IP/legal ‘challenges’.  Maliha is interested in the intersection of law and science, and digital transformation.  She gets excited about using her science, business management, and legal skills and experience to support Pearce IP’s lawyers, attorneys and clients.

MSD Defeats Halozyme’s Preliminary Injunction Application Seeking to Bar Subcutaneous Keytruda® (Pembrolizumab) in Denmark & Sweden

On 14 July 2026 The District Court of The Hague published its judgment dismissing Halozyme’s application for a preliminary injunction (PI) to prevent MSD from marketing Keytruda SC™ (pembrolizumab and berahyaluronidase alfa) in Denmark and Sweden pending the outcome of substantive proceedings.

In the substantive proceedings, MSD is seeking a declaration of non-infringement and the revocation of the Dutch part of Halozyme’s European patent EP 2792622 (EP622), which expires on 27 December 2032.  EP622 relates to recombinant human modified PH20 hyaluronidase (rHUPH20) polypeptides.  Halozyme has cross-claimed for infringement of EP622, seeking cross-border injunctions covering all countries where the patent is in force, except Germany (where a PI is already in place).  The oral hearing in the substantive proceeding is scheduled for 31 July 2026.

The preliminary injunction application arose from a statement that MSD made in its reply to Halozyme’s cross-claim.  In that statement, MSD claimed that Halozyme’s suggestion that MSD intended to bring Keytruda SC™ to market “as quickly as possible” in the relevant EU countries was “unfounded and incorrect”.  Halozyme argued that this was a “binding undertaking” or at least created a legitimate expectation that MSD would not launch Keytruda SC™ in those countries before the conclusion of the main proceedings.  Halozyme argued this undertaking or expectation was breached by MSD’s subsequent conduct in listing Keytruda SC™ in the Swedish and Danish national pricing databases.

In deciding the PI application in favour of MSD, the Court found that MSD’s statement in its pleadings did not create an enforceable undertaking and Halozyme could not reasonably have interpreted the statement as a declaration of MSD’s intent without further verification.

MSD and Halozyme are also in dispute elsewhere over patents to Halozyme’s MDASE™ subcutaneous delivery technology.  In December 2025, the Munich Regional Court granted a PI to Halozyme, preventing MSD from distributing and offering for sale in Germany Keytruda SC™, based on a finding of the Court that there was imminent infringement of EP622.  In April 2024, Halozyme sued MSD in the US, alleging that MSD’s subcutaneous Keytruda® (Keytruda Qlex®) infringes 15 patents.  MSD has successfully invalidated claims of 4 of Halozyme’s US patents before the Patent Trial and Appeal Board (PTAB) and has a further 13 petitions pending before PTAB.

While there are no reports of biosimilar subcutaneous pembrolizumab development to date, there are multiple pembrolizumab biosimilars approved or in development.  Pembrolizumab biosimilars have reportedly been launched in Paraguay (by Bioeticos in August 2025) and approved in Vietnam (by Biocad in November 2025) and Jordan (by Sana Pharma in February 2026).  Pembrolizumab biosimilars are also in clinical trials including by Formycon, Samsung Bioepis, Amgen, mAbxience, Sandoz, Celltrion, Bio-Thera, Shanghai Henlius, BioNTech, Qilu Pharmaceutical and Enzene.

Korea Eases Ph 3 Data Requirements for Biosimilar Approval

On 14 July 2026, Korea Biomedical Review reported that Korea’s Ministry of Food and Drug Safety (MFDS) is implementing a revised notice on the Regulation on Approval and Review of Biological Products.  The revisions permit Phase 3 clinical trial data to be waived for biosimilar approval applications if equivalence with the reference drug is sufficiently demonstrated through quality, non-clinical, and pharmacokinetic studies.

The change is aimed at accelerating biosimilar development and aligning Korean regulations with global standards.  The European, US and Canadian regulatory agencies have adopted similarly reduced requirements for Phase 3 clinical trial data, as follows:

Biosimilar developers are taking advantage of the reduced Phase 3 trial requirements globally, including Celltrion streamlining its US Phase 3 trial for biosimilar pembrolizumab and EU Phase 3 biosimilar secukinumab trial, Sandoz streamlining its nivolumab and ocrelizumab biosimilar trials and minimising its Phase 3 biosimilar pembrolizumab trial, and Formycon voluntarily terminating its Phase 3 clinical trial for biosimilar pembrolizumab.

Formycon Signs Strategic Biosimilar Manufacturing Partnership with OneSource

On 14 July 2026, Formycon and OneSource Speciality Pharma announced that they have entered into a strategic manufacturing partnership for biosimilars.  OneSource is an Indian-based specialty pharma Contract Development & Manufacturing Organisation (CDMO) that provides end-to-end services for complex pharmaceutical products.

Under the partnership, OneSource will provide integrated drug substance and drug product manufacturing capabilities from its biologics facility in Bangalore, to support the development of Formycon’s biosimilar programs for global markets.

Formycon’s CEO, Dr Stefan Glombitza, stated that “by adding OneSource to our network of strategic manufacturing partners, we are further strengthening our supply capabilities”.  Neeraj Sharma, OneSource’s Managing Director & CEO, added that this partnership “…reinforces our belief that India is uniquely positioned to serve as a global hub for the development and manufacturing of world-class biologics”.

In June 2025, Sweden-based Xbrane Biopharma and OneSource entered into a partnership for the commercial manufacture of Xbrane’s biosimilar portfolio.

Celltrion Terminates European Ph 3 Trial for Biosimilar to MSD’s Keytruda® (Pembrolizumab)

On 14 July 2026, ChosunBiz reported that Celltrion has voluntarily terminated the European Phase 3 trial of CT-P51, biosimilar to MSD’s Keytruda® (pembrolizumab), and has withdrawn its investigational new drug application.  The early termination of the trial in Europe is part of Celltrion’s strategy to streamline its development program for the biosimilar.

Celltrion’s strategy follows a “reflection paper” published by the European Medicines Agency in April 2025, and adopted by the Committee for Medicinal Products for Human Use (CHMP) in March 2026, which considers that, in certain circumstances, analytical comparability and pharmacokinetic data may be sufficient for approval of biosimilars, with Phase 3 trial data no longer required.

Celltrion has also recently streamlined its US Phase 3 trial for CT-P51 (pembrolizumab), having filed with the FDA an amendment to reduce the number of trial participants from about 600 to around 220.  The US Phase 3 trial plan was originally approved by the FDA in August 2024 and aims to compare the efficacy and safety of CT-P51 and Keytruda® in patients with previously untreated metastatic non-squamous non-small cell lung cancer.  The trial will be conducted over a period of 2 years.

Celltrion’s revisions to its Phase 3 trial strategy comes shortly after Samsung Bioepis announced positive results from its global Phase 1 and Phase 3 clinical trials for SB27 (pembrolizumab).  According to Samsung Bioepis, it was the first developer of a pembrolizumab biosimilar to announce global Phase 3 trial results.

Pembrolizumab biosimilars have reportedly been launched in Paraguay (by Bioeticos in August 2025) and approved in Vietnam (by Biocad in November 2025) and Jordan (by Sana Pharma in February 2026).

There are multiple pembrolizumab biosimilars in development.  Formycon’s FYB206 demonstrated pharmacokinetic bioequivalence with Keytruda® in the Phase 1 “Dahlia” study (reported in February 2026).  Formycon’s US commercialisation partner, Zydus, has previously expressed optimism that it is well-placed to file the first BLA in the US for biosimilar pembrolizumab.  Formycon has also announced agreements for commercialisation of pembrolizumab biosimilar FYB206 with MS Pharma for the MENA region and Lotus for the Asia-Pacific.

Other companies with pembrolizumab biosimilars in clinical trials include Amgen, mAbxience, Sandoz, Bio-Thera, Shanghai Henlius, BioNTech, Qilu Pharmaceutical and Enzene.  Alvotech and Dr Reddy’s have entered into a global collaboration and licence agreement to co-develop, manufacture and commercialise a Keytruda® biosimilar and Bio-Thera and Avalon are partnering on commercialisation of a pembrolizumab biosimilar (BAT3306) in Saudi Arabia/MENA.

New Indication Alert: Merck KGaA’s Erbitux® (Cetuximab) Combo EU-Approved for BRAF V600E mCRC

On 14 July 2026, Merck KGaA announced that Erbitux® (cetuximab) was approved by the European Commission for adults with BRAF V600E mutant metastatic colorectal cancer (mCRC) in combination with Pierre Fabre’s Braftovi® (encorafenib) and FOLFOX (fluorouracil, leucovori, and oxaliplatin) for first line treatment and in combination with Braftovi® in patients who have received prior systemic therapy.  The EC approval follows the CHMP’s positive opinion in May 2026.

Matthias Wernicke, Merck’s Head of Global Therapeutic Area Specialty Care stated this approval “marks an important milestone for patients … as BRAF V600E mutant mCRC is associated with a historically poor prognosis and limited effective options.”  The Erbitux®/Braftovi®/FOLFOX combination received accelerated approval by the FDA in December 2024 and traditional approval in February 2026 for the same indication.

Merck KGaA licensed the right to market Erbitux® outside the US and Canada from ImClone LLC, a wholly-owned subsidiary of Eli Lilly, in 1998.

No cetuximab biosimilars have been launched to date in China, the United States, Europe or Japan.  Alkem’s Cetuxa™ was reportedly the first cetuximab biosimilar to be approved and launched in India (January 2023 and May 2023, respectively).  Alkem’s biological arm, Enzene, entered into a strategic collaboration with Lupin in May 2023 for Indian commercialisation of Cetuxa™.  In February 2026, R-Pharm’s Arcetux™ (cetuximab) was the first biosimilar cetuximab to gain approval in Russia.  On 8 July 2026, Shanghai Henlius Biotech announced that the first patient in China had been dosed in a multicentre Phase 1 clinical trial of its cetuximab biosimilar, HLX05-N.

Samsung Bioepis Secures Preferred Formulary Status for Biosimilar to Janssen’s Stelara® (Ustekinumab) with 2 US PBMs

On 13 July 2026, Seoul Economic Daily reported that Samsung Bioepis has secured US formulary listings for Pyzchiva®/SB17, with two major pharmacy benefit managers (PBMs).

Pyzchiva® was listed as a preferred drug by CVS Caremark from 1 July 2026, following the inclusion of Pyzchiva® on the Express Scripts (ESI) formulary earlier this year.  According to the announcement, CVS Caremark and ESI cover 57% of the US PBM market, broadening patient access.

Samsung Bioepis also supplies private label versions of Pyzchiva® through agreements with distribution subsidiaries of these PBMs, including Quallent (an ESI subsidiary) and Cordavis (a CVS Caremark subsidiary).  The private label versions of Pyzchiva® are supplied under the proprietary brands of the PBM subsidiaries.

The reference drug, J&J’s Stelara® (ustekinumab) is excluded from major formularies in the US.  In May 2026, it was reported that from 1 July 2026, CVS Health would preference lower-cost, interchangeable biosimilars over Stelara® in its most common drug lists.  CVS Health’s pharmacy benefit management unit, Caremark, will transition to biosimilar versions of Stelara®, such as Sandoz/Samsung Bioepis’ Pyzchiva® and Biocon Biologics’ Yesintek™.

Pyzchiva® was developed by Samsung Bioepis and is commercialised by Sandoz in the US pursuant to a deal entered into in September 2023.  The FDA approved Pyzchiva® in July 2024 for multiple indications, including plaque psoriasis, active psoriatic arthritis, Crohn’s disease and ulcerative colitis.

There are currently seven other FDA-approved ustekinumab biosimilars in the US market: Amgen’s Wezlana® (FDA-approved October 2023; launched January 2025), Dong-A ST/Accord BioPharma’s Imuldosa® (FDA-approved October 2024; launched August 2025; added to ESI’s commercial formulary December 2025), Alvotech/Teva’s Selarsdi® (FDA-approved April 2024; launched February 2025; interchangeability status May 2025), Biocon’s Yesintek® (FDA-approved in December 2024; launched February 2025), Formycon/Fresenius Kabi’s Otulfi® (FDA-approved September 2024; launched March 2025), Celltrion’s Steqeyma® (FDA-approved December 2024; launched March 2025) and Hikma’s Starjemza™ (FDA-approved May 2025; launched November 2025).

Shanghai Henlius Doses First US Patient in Global Ph 1 Trial for Biosimilar to J&J’s Darzalex Faspro® (Daratumumab)

On 13 July 2026, Shanghai Henlius Biotech announced that the first patient in the US has been dosed in its international multicentre Phase 1 clinical trial of HLX-15-SC (daratumumab and hyaluronidase-fihj), biosimilar to J&J’s Darzalex Faspro®, for the treatment of multiple myeloma.

Shanghai Henlius’ Investigational New Drug (IND) application for the Phase 1 trial was approved by the FDA in February 2026, shortly after approval by China’s National Medical Products Administration.  The first patient in China was dosed in May 2026.

The Phase 1 study, initiated in May 2026, is designed to evaluate the pharmacokinetic similarity, safety, tolerability, immunogenicity and efficacy of HLX15-SC compared to US-Darzalex Faspro® following single and multiple subcutaneous injections in newly diagnosed multiple myeloma patients ineligible for transplant.  Primary completion of the study is expected in May 2027.

Henlius is also developing an IV form of HLX15, having completed a successful Phase 1 clinical trial of HLX15-IV against US, EU and CN sourced Darzalex® (daratumumab) in June 2024.

Both SC and IV forms of HLX15 will be exclusively commercialised by Dr Reddy’s in Europe and the US under the terms of a licence agreement announced in February 2025.

The first reported regulatory approval for a daratumumab biosimilar worldwide was announced by BIOCAD in August 2025 for Russian approval of Daratumia®.  Daratumumab biosimilars are under development, including by CSPC Pharmaceutical Group, which obtained approval in December 2025 to conduct clinical trials in China of its Daratumumab Injection, and Celltrion, whose Phase 3 clinical trial plan for CT-P44 (daratumumab) was approved in Europe in September 2025.

FDA Approves Expanded Indication for MSD’s Keytruda®/Keytruda Qlex™ (Pembrolizumab) & SC Form of Sanofi’s Sarclisa® (Isatuximab)

On 10 July 2026, the FDA announced that it approved each of MSD’s Keytruda® (pembrolizumab) and Keytruda Qlex™ (pembrolizumab and berahyaluronidase alfa-pmph) in combination with Astellas’ Padcev® (enfortumab vedotin), as neoadjuvant treatment followed by adjuvant treatment after cystectomy for adults with muscle invasive bladder cancer (MIBC).  This approval extends the previous US approval for the regimen in this setting from cisplatin-ineligible patients to all patients with MIBC who are candidates for cystectomy.

The FDA’s review of the new Keytruda®/Keytruda Qlex™ indication was conducted under Project Orbis, in collaboration with the regulatory authorities of Australia, Canada, Switzerland, the UK and Israel.  The MIBC indication for cisplatin-ineligible patients was recently approved in Europe.

A day earlier, on 9 July 2026, the FDA announced another oncology approval, with Sanofi-Aventis’ Sarclisa Escena™ (isatuximab-irfc), a subcutaneous formulation of Sarclisa®, approved as the first anticancer treatment administered via an on-body injector.

Sarclisa Escena™ is approved in combination with standard-of-care regimens for the treatment of patients with multiple myeloma across all existing indications of the IV formulation of Sarclisa®.  The drug may be administered by manual SC administration or via the CirCLIQ® on-body injector.

While isatuximab biosimilars are some way off, pembrolizumab biosimilars are in development including by Samsung Bioepis, Formycon, Amgen, mAbxience, Sandoz, Celltrion, Bio-Thera, Shanghai Henlius, BioNTech, Qilu Pharmaceutical and Enzene.  They have reportedly also been launched in Paraguay (by Bioeticos in August 2025) and approved in Vietnam (by Biocad in November 2025) and Jordan (by Sana Pharma in February 2026).

Submission Impossible – Why Arguing Without Evidence Doesn’t Quite Cut It

 

Date of decision: 19 March 2026
Body: Australian Patent Office (IP Australia)
Adjudicator:
M. Umehara (Delegate of the Commissioner of Patents)

Introduction

This decision concerns an opposition to the grant of Australian patent application no. 2019258844, filed by Fresh Inset S.A. (the Applicant) and opposed by Shanghai Lytone Biochemicals, Ltd. (the Opponent).  The application relates to compositions and articles comprising complexes of 1-methylcyclopropene (1-MCP) and alpha-cyclodextrin (α-CD), which are used to prolong the shelf life of plant products by inhibiting the effects of ethylene.  The matter was determined on the papers (absent any filed evidence) by Delegate M. Umehara, with the opposition ultimately failing on the sole ground raised.

Background

The invention addresses a well-recognised challenge in post-harvest plant science, namely, controlling ethylene exposure to delay the maturation, browning, and aging of fruit and vegetables.  The specification describes a composition combining a 1-MCP/α-CD complex with a polymer binder — specifically polyvinylpyrrolidone (PVP) or its copolymers — in a defined weight ratio, which releases 1-MCP gas upon exposure to moisture in a controlled manner.  The composition is capable of being formed into adhesive labels, sticks, or composite films for use in packaging.

Claim 1 (the only independent claim) reads:

A composition comprising:
a) a complex of 1-methylcyclopropene and α-cyclodextrin and
b) a polymer binder selected from the group consisting of polyvinylpyrrolidone, copolymers thereof, and combinations thereof,
wherein the ratio of polymer binder to complex on a weight to weight basis ranges from about 1:2 to about 4:1, and
wherein the composition is capable of releasing the 1-methylcyclopropene in the form of a gas when exposed to moisture, the composition having a release profile characterized in that when exposed at room temperature in a sealed vessel to conditions of 85% relative humidity, the composition releases substantially no 1-methylcyclopropene for a first time period of at least 1 hour after exposure; and releases 1-methylcyclopropene for a second time period of at least 5 hours that starts after the first time period.

The application was accepted in January 2025.  The Opponent filed a notice of opposition on 30 April 2025, with a statement of grounds and particulars (SGP) filed on 30 July 2025.  Notably, the Opponent filed no evidence in support of its opposition and later indicated it did not wish to be heard, though it declined to formally withdraw the opposition.  The Applicant also filed no evidence but lodged written submissions on 26 February 2026.  The Delegate observed that, where an opponent loses interest in prosecuting an opposition, the appropriate course is ordinarily to withdraw the opposition, which would then prompt consideration of re-examination before grant.

Key Issues

The sole ground of opposition raised was lack of inventive step.  The Opponent argued that claims 1 to 17 would have been obvious to a person skilled in the art in light of: (1) common general knowledge; (2) WO 2012/134539 A1 (D1), relating to cyclodextrin complexes with controlled moisture; (3) US 20170150716 A1 (D2), relating to a polymer laminate for inhibiting plant ethylene response; or any combination of these.

Consideration

The Delegate noted that the burden of proof (on the balance of probabilities) rests with the Opponent.  Applying principles from Hood v Bush Pharmacy Pty Ltd [2020] FCA 1686, the Delegate confirmed that obviousness requires more than identifying that something was “worthwhile to try” — there must be a reasonable expectation of success and a direct path from the prior art to the claimed invention.

On common general knowledge alone, the Delegate accepted that the general use of 1-MCP and its complexation with α-CD were known in the art, but found that the SGP provided no reasoning as to how this knowledge would lead a skilled person to the specific combination of PVP binder, the claimed ratio range, and the particular release profile claimed.  The inventive step ground therefore failed based on common general knowledge alone.

Regarding D2, the Delegate observed that the worked examples in D2 already disclosed a PVP-to-1-MCP/α-CD complex ratio of approximately 3:1 — falling squarely within the claimed range (of “from about 1:2 to about 4:1”).  However, when tested under conditions of 89.9% humidity at 25°C, D2’s composition released 69% of its 1-MCP within the first hour and completed release by five hours.  This directly contrasts with the claimed profile, which requires substantially no release in the first hour.  The Delegate noted that it is apparent that not all compositions having these components will achieve the claimed release rate.  The Delegate further noted that the worked examples in the specification provide guidance for a person skilled in the art to prepare compositions having the claimed 1-MCP release profile and comprising 1-MCP/α-CD complex and PVP or copolymers thereof with additional carrier excipients as well.  The Delegate concluded that since no expert evidence was provided by the Opponent at all, the Opponent had failed to sufficiently convince the Delegate how a skilled person would, through routine adjustment of the polymer-complex ratio or other additives, arrive at a composition achieving the claimed delayed-release profile — particularly given that D2’s composition, already within the claimed ratio range, failed to achieve it.  As a result, claims 1-17 did not lack an inventive step in light of D2, alone or in combination with the provided common general knowledge.

On D1, the Delegate found that there would be no motivation for a skilled person to substitute the curable monomer required in D1 with PVP and/or copolymers thereof as disclosed in D2.  The adhesive referenced in D1 served an entirely different function to the polymer binder in claim 1.  The Opponent’s suggestion that the claimed release profile could be achieved merely by controlling atmospheric moisture levels was dismissed as not equivalent to a composition having a given release profile when exposed to conditions of 85% relative humidity at room temperature in a sealed vessel.  The Delegate noted that the Opponent did not provide any evidence to show how this may be conceived by a person skilled in the art or how it may be achieved without invention. As a result, claims 1-17 did not lack inventive step in light of D1, alone or in combination with the provided common general knowledge and/or D2.

Outcome

The opposition failed.  The Opponent did not establish that the subject matter of claims 1 – 17 lacked inventive step in light of common general knowledge, D1, D2, or any combination thereof.  Costs were awarded against the Opponent.

Implications

This decision offers several practical insights.  First, it underscores the critical importance of filing evidence in patent oppositions — an opponent who fails to support its grounds with expert evidence faces a near-insurmountable burden, particularly on the inherently fact-intensive question of inventive step.  Second, the decision illustrates that where prior art discloses compositions with overlapping parameters yet fails to achieve the claimed functional result, a functional limitation in a claim can carry genuine patentable weight.  The release profile requirement in claim 1 proved decisive.  Third, the Delegate’s comments about the appropriate conduct of opponents who lose interest in proceedings serve as a practical reminder that withdrawal, rather than passive non-participation, is the proper course — and may avoid adverse cost consequences.


 

About Pearce IP

Pearce IP is a privately owned/independent, specialist, life-sciences focussed, intellectual property/law firm offering lawyers and attorneys in Australia and New Zealand.

Our lawyers and attorneys specialise in pharma, biopharma, biotech, ag-tech, food-tech, med-tech, although our work is broader than these industries.

Pearce IP and its leaders are ranked in every notable legal directory including: Chambers & Partners, Legal 500, IAM Patent 1000, IAM Strategy 300, MIP IP Stars, Doyles Guide, WTR 1000, Best Lawyers, WIPR Leaders, Best Law Firms, among others. In 2025, Pearce IP was honoured by Australasian Lawyer and New Zealand Lawyer as a Top Specialist Firm, 5 Star Employer of Choice, and the “Standout Winner” for Inclusion and Culture (<100 employees).  

Pearce IP is the only leading IP firm in Australia and New Zealand with a female founder, and is certified by WEConnect International as women owned.

 

Helen Macpherson

Helen Macpherson

Executive, Lawyer (Head of Litigation –Australia)

Helen is a highly regarded intellectual property specialist and industry leader with more than 25 years’ experience advising on patents, plant breeder’s rights, trade marks, copyright and confidential information. She is known for her expertise in complex, high-value patent matters and leverages her technical background in biochemistry and molecular biology to work across a wide range of technologies, including inorganic, organic, physical and process chemistry, biochemistry, biotechnology (including genetics, molecular biology and virology), and physics. Helen is an active member of the Intellectual Property Committee of the Law Council of Australia and the Intellectual Property Society of Australia and New Zealand.

Donna Meredith

Donna Meredith

Associate, Patent & Trade Mark Attorney

Donna is a Patent and Trade Mark Attorney with more than 8 years’ post-qualification experience, and a background in biotechnology and biology.

Donna supports Australian and international clients in a range of life sciences fields including nanoparticles, pharmaceuticals, biopharmaceuticals, biotechnology, DNA sequencing, cell and gene therapy, CRISPR technologies, protein chemistry, formulation chemistry, chemical compounds, biofuels, plant varieties, ag-tech, food-tech and medical devices.

Sally Paterson

Sally Paterson

Executive, Lawyer (NZ), Patent & Trade Mark Attorney (AU, NZ)

Sally is a senior Trans-Tasman Patent and Trade Mark Attorney, and a New Zealand registered lawyer with over 20 years’ experience in IP.  Sally’s particular expertise is in life sciences, drawing from her background in biological sciences. Sally is well respected in the New Zealand IP community for her broad ranging skills in all aspects of intellectual property advice, protection and enforcement. Sally has extensive experience securing registration for patents, designs and trade marks in New Zealand, Australia and internationally, providing strategic infringement, validity and enforceability opinions, acting in contentious disputes including matters before the courts of New Zealand and before IPONZ and IP Australia, and advising on copyright and consumer law matters.

Samsung Bioepis and Proteina Sign Licence Option Agreement for AI-Based Antibody Drug Development Project

On 9 July 2026, Samsung Bioepis announced it signed a licence option agreement with Proteina, a Korean biotechnology company, to use the results of an R&D project aimed at developing AI-based antibody therpeutics.

The R&D project was launched in October 2025 and is an initiative led by the Ministry of Health and Welfare, which Samsung Bioepis and Proteina are pursuing together with a research team at Seoul National University.

Under the agreement, Proteina is responsible for leading the discovery and validation of antibody drug candidates using AI, whilst Samsung Bioepis is responsible for preclinical development through to the filing of Investigational New Drug applications.

If Samsung Bioepis exercises its licence option, it can proceed with clinical trials and commercialisation of the drug(s), in exchange for payments to Proteina for R&D achievements and royalties.  The companies aim to identify antibody drug candidates by 2027.  The financial details of this agreement have not been disclosed.

AI-supported drug development is a growing area of interest.  In May 2023, Sandoz and Just-Evotec Biologics entered into a partnership that utilised Just-Evotec Biologics’ AI driven drug development platform and manufacturing technology.  This partnership was expanded in July 2024, with Sandoz acquiring Just-Evotec Biologics EU and its J.POD® biologics manufacturing facility in Toulouse, France in July 2025.

Accord BioPharma’s Biosimilar to Amgen’s Neulasta® (Pegfilgrastim) Approved in US

On 9 July 2026, PR Newswire reported that the FDA has approved Accord BioPharma’s Ennumo™, biosimilar to Amgen’s Neulasta® (pegfilgrastim), for all approved reference indications.

According to the announcement, Accord is now the only company in the US offering two distinct pegfilgrastim biosimilars to Amgen’s Neulasta®, Ennumo™ (pegfilgrastim-pccg) and Udenyca® (pegfilgrastim-cbqv).  Udenyca® was acquired by Intas Pharmaceuticals (Accord’s parent company) from Coherus Biosciences in August 2025.

There are a number of other pegfilgrastim biosimilars approved in the US, including Mylan/Biocon’s Fulphila® (approved June 2018, launched July 2018), Coherus/Accord’s Udenyca® (PFS approved November 2018, PFS launched January 2019; autoinjector approved March 2023, autoinjector launched May 2023; Udenyca OnBody® approved December 2023, launched February 2024), Sandoz’s Ziextenzo® (approved November 2019), Pfizer’s Nyvepria® (approved June 2020), Amneal/Kashiv’s Fylnetra™ (approved May 2022, launched May 2023), Fresenius’ Stimufend® (approved September 2022, launched February 2023) and Lupin’s Armlupeg™ (approved December 2025).

Teva Inks Licensing Deal with Polpharma Biologics for Biosimilar to Roche’s Ocrevus® (Ocrelizumab)

On 9 July 2026, Teva and Polpharma Biologics announced that they entered into an exclusive licensing agreement for the commercialisation of intravenous and subcutaneous formulations of Polpharma Biologics’ PB018, biosimilar to Roche’s Ocrevus® (ocrelizumab).

PB018 is currently in early development and has not yet entered clinical trials.  According to the US clinical trials database, Polpharma is planning to commence a Phase 1 study in October 2026 comparing PB018 with Ocrevus® in patients with multiple sclerosis.

Under the agreement, Swiss-based Polpharma Biologics will be responsible for the development, manufacture and supply of the ocrelizumab biosimilar, while Israeli-based Teva, will be responsible for regulatory submissions and commercialisation in the US, Europe, Brazil, Canada, Australia, New Zealand, Israel and Turkey.

Polpharma has previously entered into a licensing agreement with MS Pharma in relation to the commercialisation of PB018 (and other biosimilars) in the MENA region (September 2025).

Ocrelizumab biosimilars are in clinical trials sponsored by Amgen (Phase 3 underway, estimated primary completion in 2027), Biocad (Phase 3, enrolment commenced November 2025), Sandoz (Phase 3 trial underway, estimated primary completion in November 2026), Celltrion (Phase 3 IND for CT-P53 partially approved by the EMA in August 2023, currently recruiting, estimated primary completion dated in 2027) and R-Pharm (Phase 1 study commenced April 2025, estimated primary completion in January 2026).  In January 2026, Samsung Bioepis announced that it had added an ocrelizumab biosimilar to its pipeline.

International Patent Expertise Strengthens Pearce IP’s Life Sciences Offering

Pearce IP is pleased to welcome Sarah Dieckmann as an Associate and Foreign Registered Patent Attorney, further strengthening the firm’s specialist capability in biotechnology and life sciences intellectual property.

Sarah brings more than 10 years’ experience in intellectual property law, together with a PhD in Biology and extensive international experience as a German Patent Attorney, European Patent Attorney and in-house Senior Patent Counsel for a global consumer goods company. Her background spans private practice and industry, providing clients with commercially focused intellectual property advice informed by both legal expertise and practical business experience.

Sarah advises biotechnology and life sciences companies across the full patent lifecycle, including patent drafting and prosecution, opposition proceedings, freedom-to-operate assessments, portfolio management and strategic intellectual property advice. She has particular expertise in molecular biology, microbiology, enzyme technology and genetics, helping innovators develop intellectual property strategies that support commercialisation, investment and long-term growth.

Her appointment reflects Pearce IP’s continued commitment to providing specialist intellectual property advice to the pharmaceutical, biopharmaceutical and life sciences sectors across Australia, New Zealand and international markets.

Commenting on her appointment, Sarah said:

“I am excited to join Pearce IP and work alongside a team recognised for its deep expertise in life sciences intellectual property. I look forward to helping innovative companies protect and maximise the value of their inventions as they develop and commercialise new technologies.”

Commenting on Sarah’s appointment, Pearce IP CEO & Founder, Executive Lawyer (AU, NZ), Patent Attorney (AU, NZ) & Trade Mark Attorney (AU), Naomi Pearce, said:

“Sarah’s combination of scientific expertise, international patent experience and commercial insight makes her an outstanding addition to our team. Her appointment further strengthens our ability to support biotechnology and life sciences clients with sophisticated intellectual property strategies across global markets.”

To learn more about Sarah Dieckmann and her experience, view her profile or contact her directly at sarah.dieckmann@pearceIP.law.


 

About Pearce IP

Pearce IP is a privately owned/independent, specialist, life-sciences focussed, intellectual property/law firm offering lawyers and attorneys in Australia and New Zealand.

Our lawyers and attorneys specialise in pharma, biopharma, biotech, ag-tech, food-tech, med-tech, although our work is broader than these industries.

Pearce IP and its leaders are ranked in every notable legal directory including: Chambers & Partners, Legal 500, IAM Patent 1000, IAM Strategy 300, MIP IP Stars, Doyles Guide, WTR 1000, Best Lawyers, WIPR Leaders, Best Law Firms, among others. In 2025, Pearce IP was honoured by Australasian Lawyer and New Zealand Lawyer as a Top Specialist Firm, 5 Star Employer of Choice, and the “Standout Winner” for Inclusion and Culture (<100 employees).  

Pearce IP is the only leading IP firm in Australia and New Zealand with a female founder, and is certified by WEConnect International as women owned.

 

Shanghai Henlius Doses First Patient in China in Ph 1 Trial for Biosimilar to Eli Lilly/Merck KGaA’s Erbitux® (Cetuximab)

On 8 July 2026, Shanghai Henlius Biotech announced that the first patient in China has been dosed in its multicentre Phase 1 clinical trial of HLX05-N, biosimilar to Eli Lilly/Merck KGaA’s Erbitux® (cetuximab).

The Phase 1 study, initiated in June 2026, is designed to evaluate the pharmacokinetic similarity, efficacy, safety and immunogenicity of HLX05-N compared with US- and EU-sourced Erbitux® in patients with metastatic colorectal cancer (mCRC).  Primary completion of the study is expected in June 2027.

The FDA approved the Investigational New Drug (IND) application for the Phase 1 trial in May 2026, shortly after the approval of Henlius’ IND by China’s National Medical Products Administration in April 2026.

No cetuximab biosimilars have been launched to date in China, the United States, Europe or Japan.  Alkem’s Cetuxa™ was reportedly the first cetuximab biosimilar to be approved and launched in India (January 2023 and May 2023, respectively).  Alkem’s biological arm, Enzene, entered into a strategic collaboration with Lupin in May 2023 for Indian commercialisation of Cetuxa™.  In February 2026, R-Pharm’s Arcetux™ (cetuximab) was the first biosimilar cetuximab to gain approval in Russia.

BioBlast® Editor and Contributing Author

Naomi Pearce & Emily Bristow

Naomi Pearce & Emily Bristow

Editor: Naomi Pearce, Executive Lawyer, Patent Attorney & Trade Mark Attorney
Contributing Author: Emily Bristow, Law Graduate

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