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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.

Pearce IP BioBlast® for the fortnight ending 11 September 2026

Pearce IP provides weekly reports on global biosimilars activities in the Pearce IP BioBlast®.  Significant biosimilar activities for the fortnight ending 11 September 2026 are set out below:


Denosumab

On 11 September 2026, Shanghai Henlius Biotech announced that China’s National Medical Products Administration (NMPA) has accepted for review the new drug… Read more here.

 

On 4 September 2026, Daily Pharm Korea reported that South Korean-based Shin Poong Pharm has received Korean regulatory approval for Denovon™, biosimilar… Read more here.

Ocrelizumab

On 4 September 2026, Business Standard reported that the Subject Expert Committee of India’s Central Drugs Standard Control Organisation (CDSCO) has given… Read more here.

Omalizumab

On 11 September 2026, Celltrion’s Omlyclo®, biosimilar to Genentech/Novartis’ Xolair® (omalizumab), was approved in Australia in a 300 mg/2 mL solution for injection… Read more here.

Pembrolizumab

On 3 September 2026, Invagen Pharmaceuticals, a wholly owned subsidiary of Cipla, announced that it has entered into a strategic partnership with China’s Qilu… Read more here.

Pertuzumab

On 8 September 2026, Biocon announced that, in partnership with Brazilian state-owned pharmaceutical laboratory, Bahiafarma, and Brazilian biotechnology company… Read more here.

Trastuzumab deruxtecan, Pertuzumab

On 1 September 2026, AstraZeneca announced that Enhertu® (trastuzumab deruxtecan), developed in conjunction with Daiichi Sankyo, in combination with… Read more here.

Ustekinumab

On 3 September 2026, Samsung Bioepis announced that its Ustekinumab BS Intravenous Infusion [NIPRO] (SB17), biosimilar to Janssen’s Stelara®, was… Read more here.

Vedolizumab

On 1 September 2026, Takeda commenced BPCIA proceedings against Alvotech in the US District Court for the District of New Jersey in relation to Alvotech’s… Read more here.

Biopharma Deals

On 2 September 2026, South Korean-headquartered Alteogen announced that it has entered into an option and licence agreement with Novartis for the… Read more here.

Biopharma News

On 8 September 2026, Sandoz announced that it is aiming to establish a portfolio of more than 100 biosimilars by 2040 as part of its Bio100 plan to maximise… 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 Law “Executive 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 1000, IAM 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.

Dr Reddy’s Enters India’s Immuno-Oncology Market With Biosimilar Nivolumab Launch

On 15 September 2026, The Economic Times reported that Dr Reddy’s has launched Nivorz™, biosimilar to BMS’ Opdivo® (nivolumab), in India.  Nivorz™ will be available in single-dose vial presentations (40 mg, 100 mg and 240 mg) and will be manufactured at Dr Reddy’s biologics facility in Bachupally, Hyderabad.

Nivorz™ is the second nivolumab biosimilar to be launched in India following Zydus’ Tishtha®, which was the first nivolumab biosimilar to be launched in the world when it became available in India in January 2026 (approved July 2024).

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, and Boan Biotech’s BA1104.

Amgen Files First FDA Application for Biosimilar Nivolumab Sparking BPCIA Litigation

During a presentation on 15 September 2026, Amgen confirmed that it has filed an abbreviated Biologics License Application (aBLA) with the FDA for a biosimilar to Bristol Myers Squibb/Ono Pharmaceutical’s Opdivo® (nivolumab).  The aBLA has been accepted for review.  This is the first publicly disclosed aBLA to have been filed and accepted in the US in relation to biosimilar nivolumab.  Amgen is expecting an FDA decision in relation to its nivolumab biosimilar, ABP 206, by year end.

As a result of the FDA filing, BMS and Ono commenced BPCIA litigation against Amgen in relation to ABP 206 on 14 September 2026.  In their complaint filed in in the US District Court for the District of Delaware, BMS/Ono allege that Amgen infringes 7 US patents in relation to nivolumab and methods of treatment using nivolumab (US Patent Numbers 8,008,449, 9,856,320, 10,072,082, 12,590,154, 12,624,107, 12,590,153, and 12,479,917).

BMS and Ono are seeking remedies including a preliminary and/or permanent injunction to restrain Amgen from infringement the asserted patents, including by manufacturing or selling biosimilar nivolumab in the US while the patents remain in force.

The US litigation is not the first to be fought around the world in relation to nivolumab biosimilars.  In January 2026, the High Court of Delhi reversed on appeal a preliminary injunction granted to BMS in relation to Zydus’ biosimilar, Tishtha™ (approved July 2024).

BMS’ patent rights for nivolumab are being challenged including in the EU where EP 3 288 980, for a composition comprising nivolumab for use in a method of treating PD-L1-positive melanoma, was revoked in July 2026 following an opposition by 5 “strawperson” opponents.

A number of nivolumab biosimilars are under development including Sandoz’s JPB898, Xbrane/Intas’ Xdivane™, Reliance Life Sciences’ RLS-Nivolumab, Enzene’s candidate, Boan Biotech’s BA1104, and Shilpa’s intravenous nivolumab biosimilar.

Celltrion Files Ph 4 Clinical Trial Application with FDA for High-Dose (240 mg) SC Infliximab

On 15 September 2026, Celltrion announced that it has filed an Investigational New Drug (IND) application with the FDA for a Phase 4 clinical trial of high-dose (240 mg) Zymfentra™ (SC infliximab), biosimilar to Janssen’s Remicade® (IV infliximab).

The trial aims to demonstrate non-inferiority by comparing high dose intravenous infliximab with high dose Zymfentra™, a subcutaneous formulation, in patients with Crohn’s disease and ulcerative colitis.  On successful completion of the study, Celltrion plans to offer a high dose Zymfentra™ option in the US, in addition to its 120 mg formulation.

This strategy mirrors a high dose strategy already being pursued by Celltrion in Europe, where Celltrion’s infliximab product is known as Remsima SC™.  According to Celltrion, the strategy has helped Remsima SC™ gain approximately 32% EU market share.

Celltrion has also disclosed that it is conducting global clinical trials to expand the indications for Zymfentra™ to include rheumatoid arthritis.

Zymfentra™ (120 mg) was the first subcutaneous formulation of infliximab approved by the FDA for ulcerative colitis and Crohn’s disease in October 2023.  It was launched in the US in February 2024.

Samsung Bioepis Defeats Pfizer’s Claims in Long-Running Australian Etanercept Patent Infringement Proceedings

In a judgment published on 15 September 2026 (but delivered on 27 August 2026), the Federal Court of Australia found that Pfizer had failed to establish that Samsung Bioepis’ production of Brenzys®, biosimilar to Pfizer’s Enbrel® (etanercept), infringed Pfizer’s Australian patent AU2005280034.  In addition, the Judge determined that all but one of the asserted claims of the patent was invalid for lack of inventive step.

The patent at issue (which expired on 26 August 2025) related to large scale production of therapeutic polypeptides (such as etanercept) in a cell culture medium.  Key to the non-infringement finding was the Judge’s view that Pfizer had failed to establish that Samsung Bioepis’ culture process resulted in cells that reached between 20% to 80% of the maximum viable cell density that would be achieved if initial growth phase culture conditions were allowed to continue, rather than being altered to a subsequent production phase (as required by the claims of the patent).

The decision comes over four years after Pfizer first filed the infringement proceedings in May 2022 against Samsung Bioepis and other respondents (including MSD, Organon and Arrow Pharmaceuticals).  Those proceedings followed an action for preliminary discovery decided in 2017, which permitted Pfizer to obtain documents from the respondents in order to determine whether to commence proceedings against them for patent infringement.

It is not yet known whether Pfizer will appeal the decision.

Samsung Bioepis’ Brenzys® was the first biosimilar etanercept approved in Australia in July 2016 and was PBS listed in April 2017.  Other etanercept biosimilars approved and launched in Australia are Biocon/Alphapharm’s Nepexto® (approved September 2020, PBS listed July 2025) and Sandoz’s Enbrel® (approved November 2017, PBS-listed October 2025).

Clear First. Launch Second. Trade Mark Clearance Lessons from Zip Co v Firstmac.

Clear first, launch second: what the High Court’s decision in Zip Co Limited v Firstmac Limited [2026] HCA 16 means for new brands.

Choosing a new brand can be an exciting part of launching a product, service or business. Once the preferred name has gained internal support, however, commercial momentum can build quickly: domains are secured, packaging is commissioned, regulatory documentation is prepared and marketing plans begin to take shape.

A recent High Court decision provides a timely reminder that trade mark clearance needs to occur before that momentum becomes too difficult (and expensive!) to reverse.

In Zip Co Limited v Firstmac Limited [2026] HCA 16, the High Court considered whether buy-now-pay-later provider Zip Co could rely on “honest concurrent use” as a defence to infringement of an earlier trade mark registration for the word mark ZIP by non-bank lender, ‘Firstmac’.

The lessons from the decision apply to any business developing a new brand, but are particularly important for pharmaceutical and healthcare companies, where a proposed name can become embedded in regulatory, clinical and commercial workstreams well before a product reaches the market.

What happened in Zip Co v Firstmac?

Firstmac was the registered owner of an Australian trade mark registration for the word mark ZIP in relation to financial services in class 36 since 2004.

The founders of Zip Co independently selected the ZIP and ZIP MONEY brands without initially knowing about Firstmac’s registration. However, evidence established that Zip Co did not search the Australian Trade Marks Register or obtain legal advice before filing its trade mark applications.

In October 2013, IP Australia issued adverse examination reports identifying Firstmac’s earlier registration as an obstacle to registration of Zip Co’s ZIP and ZIP MONEY brand names on the basis that the marks closely resembled one another and covered similar services.

The reports received only cursory attention from Zip Co’s founders, and despite becoming aware of Firstmac’s earlier registration, Zip Co proceeded to launch under ZIP-formative branding the following month. In the years that followed, Zip Co subsequently developed a substantial business and reputation in its ZIP brands.

When Firstmac later commenced infringement proceedings, Zip Co sought to rely on the honest concurrent use defence. Broadly, honest concurrent use can provide a pathway to registration – and, in some circumstances, a defence to infringement – where similar marks have been used honestly alongside one another without any instances of consumer confusion.

However, the High Court unanimously found that Zip Co had not established the requisite ‘honesty’ component.

Why didn’t Zip Co’s later success solve the problem?

The High Court confirmed that honesty must be assessed at the time of each potentially infringing use. Zip Co therefore needed to establish an honest state of mind from the point at which it first launched its services under the ZIP-formative marks.

At that time, Zip Co had received examination reports specifically identifying Firstmac’s earlier registration as an impediment. The critical issue was not that the Zip Co founders had originally selected the ZIP-formative marks dishonestly: their independent and honest adoption of the marks before learning of Firstmac’s registration remained relevant. Rather, Zip Co bore the onus of positively establishing that its state of mind was honest when potentially infringing use began in November 2013, by which time it knew that IP Australia considered the earlier registration a material impediment to legitimate use of its marks.

Can I use my brand if someone else has a similar trade mark?

It depends on the circumstances.  As the Zip Co v Firstmac decision highlights, the key issue is what the business knew, believed and decided when it began using the brand.  Knowledge of an earlier trade mark is not automatically fatal, but it can weigh strongly against honesty – particularly where a business is warned of the conflict and chooses not to address it.

Zip Co had chosen not to engage with the adverse reports and did not lead sufficient evidence that, despite the warning, its decision-makers genuinely believed that consumers would not be confused or that Zip Co would not benefit from any confusion. Nor was there sufficient evidence to establish that its failure to turn its mind to those matters was not reckless. Those gaps meant that Zip Co failed to prove the requisite honesty. Its later commercial success and substantial reputation could not retrospectively supply the evidence missing at the time use commenced.

Importantly, the High Court did not hold that knowledge of an earlier trade mark is invariably fatal to honest concurrent use, or that carelessness is itself equivalent to dishonesty. A failure to search the Register will not, without more, establish a lack of honesty. The inquiry is directed to the user’s actual state of mind, assessed against the standards of ordinary, decent people. However, knowledge of an earlier registration will ordinarily weigh strongly against a finding of honesty – particularly where the business has received a specific warning that the registration may materially impede its proposed use and then elects not to engage with it.

What does the Zip Co decision mean for brand owners?

Businesses sometimes assume that a trade mark issue can be dealt with later, once the proposed brand has been tested in the market or sufficient use and reputation has been established. And this can sometimes be true, but the ZIP decision illustrates the danger in that approach.

The central lesson is therefore not simply that businesses should search before launch – it is that the discovery of a potentially conflicting right creates a real decision point. A name may have been selected independently and in good faith, but that does not answer whether the business acts honestly when it later commences or continues use with knowledge of the obstacle. What the business investigates, believes and decides at that point may become critical.

An adverse search result or examination report should therefore be actively assessed rather than parked while the brand gathers momentum. If the business wishes to proceed, it should obtain advice, test the basis on which use is considered legitimate and document the reasoning at the time. Honest concurrent use may remain available in an appropriate case, but it must be proved by evidence of the user’s actual state of mind – it cannot be assumed that later reputation, market success or an absence of known confusion will fill an evidentiary gap left at launch.

Why is early trade mark clearance critical for pharmaceutical and healthcare launches?

For pharmaceutical and healthcare businesses, changing a brand late in the development process can be particularly difficult.

Before a product becomes publicly available, its proposed name may already appear in:

  • regulatory applications and supporting dossiers;
  • clinical trial and investigator materials;
  • product information and consumer medicine information;
  • packaging, labels and instructions for use;
  • manufacturing, supply and distribution agreements;
  • healthcare-professional education;
  • patient-support programs; and
  • websites, applications and other digital platforms.

This can create understandable resistance to changing a preferred name. However, the fact that a brand has become costly or operationally difficult to change does not resolve the underlying infringement risk or establish an entitlement to continue using it. By the time the issue is revisited, the business may have lost the practical flexibility it had when the name was first selected, without having improved its legal position.

The practical objective should therefore be to identify and assess trade mark issues while alternative names remain commercially viable, not after the business has become committed to a single option.

Four practical steps for brand owners

What should brand owners do before launching a new brand?

Brand owners should conduct trade mark clearance early, assess any conflicting marks, document the risk assessment and obtain legal clearance before committing to regulatory, packaging or launch activities. Pearce IP’s experienced trade mark lawyers and attorneys can assist when potential issues arise, advising on the clearance, protection and management of new product and corporate brands in Australia, New Zealand and internationally.

  1. Conduct trade mark clearance while several names remain available

Trade mark clearance should take place before a proposed name is approved internally or incorporated into regulatory, packaging and launch workstreams.

A search should extend beyond identical marks. Depending on the brand and the markets in which it will be used, it may need to consider:

  • visually, aurally and conceptually similar marks;
  • related goods and services;
  • unregistered brands and marketplace use;
  • company names, domain names and digital use; and
  • relevant overseas jurisdictions.

Pharmaceutical naming may also require consideration of regulatory requirements, International Nonproprietary Names, protected stems and medication-safety concerns.

  1. What should a business do if trade mark clearance identifies a conflicting mark?

A problematic search result or examination report should not be treated as an administrative matter that can simply be parked until closer to launch.

The business should promptly determine:

  • whether the earlier registration presents a genuine infringement risk;
  • whether the earlier mark may be vulnerable to challenge;
  • whether consent or a coexistence arrangement may be available;
  • whether changes to the proposed mark or commercial scope could reduce the risk; and
  • whether an alternative name should be selected.

Not every citation requires a rebrand. The important point is that the issue is investigated and an informed decision is made before use begins.

  1. Why should businesses document their trade mark clearance assessment?

If a business decides to proceed despite an identified earlier right, it should carefully document the basis for that decision.

Relevant records may include legal advice, information about the selection of the name, differences between the respective marks and offerings, the intended market, investigations into the earlier owner’s use and any attempts to obtain consent.

This is not merely an evidence-gathering exercise. It helps ensure that the risk has been properly considered by the relevant decision-makers.

  1. When should trade mark clearance be completed before launch?

The most effective protection is often procedural. Businesses should incorporate trade mark clearance into their formal approval process for new products, services and campaigns.

Ideally, legal approval should be obtained before:

  • the proposed name is treated as final;
  • regulatory applications are submitted;
  • packaging or labels are commissioned;
  • public announcements are made; or
  • significant launch expenditure is incurred.

This is particularly important where legal, regulatory, product and marketing teams operate on different timelines.

The key takeaway

The ZIP decision does not mean that businesses can never proceed after discovering an earlier mark. Some obstacles can be distinguished, negotiated, challenged or otherwise overcome.

It does mean that a known obstacle should not be ignored in the expectation that commercial success will eventually cure the problem.

The best time to resolve naming risk is while the name is still changeable. Early clearance preserves options, supports an informed launch decision and can prevent a trade mark issue from becoming a much larger commercial problem.

Pearce IP can assist with the clearance, protection and management of new product and corporate brands in Australia, New Zealand and internationally. Use our Contact Form or email us at info@pearceIP.law or call Australia Tel: +61 (0) 2 9023 9988 or New Zealand Tel: +64 (4) 886 1199.


 

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.

 

Sarah Ramsey-Caudle

Sarah Ramsey-Caudle

Sarah Ramsey-Caudle is a senior intellectual property lawyer and registered Trans-Tasman Trade Mark Attorney with nearly a decade of experience advising on brand protection, enforcement and commercialisation in Australia, New Zealand and internationally.

Sarah specialises in trade marks and brand protection, including clearance and filing strategies, portfolio management, prosecution, oppositions, non-use proceedings, infringement and enforcement, copyright, licensing and IP commercialisation.

She has advised some of the world’s leading consumer brands, with particular expertise in cosmetics, fashion, retail, food and beverage, and supply chain sectors. Sarah is known for her responsive, commercial and pragmatic approach, providing clear advice aligned with broader business objectives.

Sarah has experience in contentious matters before the Australian Trade Marks Office and Federal Court of Australia. She holds a Master of Intellectual Property Law from the University of Melbourne, a Bachelor of Laws (Honours) and Bachelor of Commerce (International Business) from the University of Adelaide, and is a member of IPSANZ.

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 Law “Executive 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 1000, IAM 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.

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.

Celltrion’s 300 mg (High Dose) Biosimilar Omalizumab Approved in Australia

On 11 September 2026, Celltrion’s Omlyclo®, biosimilar to Genentech/Novartis’ Xolair® (omalizumab), was approved in Australia in a 300 mg/2 mL solution for injection in pre-filled pen (PFP) and pre-filled syringe (PFS) forms.

The Australian approval follows launch of the 300 mg formulation of Omlyclo® in Europe (August 2026) and Korea (March 2026) and its approval in a number of other countries including the US (December 2025) and Canada (January 2026).

Omlyclo® is the only biosimilar omalizumab to have been approved in Australia, with the 75 mg/ 0.5 mL and 150 mg/1 mL PFS PBS-listed on 1 August 2025 and launched in Australia in September 2025, and the 75 mg/ 0.5 mL and 150 mg/1 mL PFP TGA-approved in August 2025 and recommended for PBS listing in April 2026.

Omalizumab biosimilars in development include Kashiv BioSciences/Alvotech’s ADL-018/AVT23, with an application for ADL-018 accepted for review by Health Canada in June 2026 and marketing applications for AVT23 accepted by the UK’s MHRA in March 2025 and the European Medicines Agency in October 2025.  Under an exclusive licensing agreement with Kashiv entered in October 2023, Alvotech holds the commercialisation rights to ADL-018/AVT23 in Canada, together with the European Economic Area, UK, Switzerland, Australia and New Zealand.  Kashiv has entered into agreements for commercialisation of ADL-018 with Cristália for LATAM (August 2025) and MS Pharma for MENA markets (August 2025).

Teva’s biosimilar omalizumab applications have been accepted for review in the US and EU (March 2026) and CuraTeQ announced Phase 3 study results for its biosimilar omalizumab, BP11, in April 2026.  Mabpharm claims to have had an omalizumab biosimilar (Aomaishu®) approved for marketing in China in May 2023.

Shanghai Henlius’ Biosimilar Denosumab Application Accepted in China

On 11 September 2026, Shanghai Henlius Biotech announced that China’s National Medical Products Administration (NMPA) has accepted for review the new drug application (NDA) for HLX14 (120 mg/1.7 mL per vial), biosimilar to Amgen’s Xgeva® (denosumab).  This follows NMPA acceptance of Henlius’ NDA for a 60 mg/1.0 mL strength of HLX14 in December 2025.

HLX14 was approved in the EU and the US in September 2025, as Bildyos® (referencing Amgen’s Prolia®) and Bilprevda® (referencing Xgeva®), for all reference indications.  In March 2026, Henlius and its licensee, Organon, settled BPCIA litigation brought by Amgen in June 2025 in relation to Bildyos® and Bilprevda®.  HLX14 has also been approved in Canada, as Bildyos® and Tuzemty® (March 2026).

Shanghai Henlius entered into a licence agreement with Organon in June 2022 under which Organon has exclusive global commercialisation rights to HLX14 for all countries except China, Hong Kong, Macau and Taiwan.

There are a number of denosumab biosimilars approved in China, including Mabwell’s Mailishu® (approved March 2024, referencing Xgeva®) and Maiweijian® (approved May 2026, referencing Prolia®); Boan Biotech’s Boyoubei® (November 2022, referencing Prolia®) and Boluojia® (approved 2024, expanded May 2026, referencing Xgeva®); and Mabpharm’s Puboli® (approved June 2026, referencing Prolia®).

Plugging the Rattlejack Leak… When Patent Amendments Can’t Rewrite History

Kutti Bay Investments Pty Ltd v Rattlejack Innovations Pty Ltd [2026] FCA 422

Date of decision: 13 April 2026
Body:  Federal Court of Australia
Adjudicator: Justice Rofe

Introduction

Justice Rofe of the Federal Court of Australia has delivered yet another decision in the long running dispute between Kutti Bay Investments Pty Ltd (Kutti Bay, formerly Jusand Nominees Pty Ltd) over patents for a “Safety System and Method for Protecting Against a Hazard of Drill Rod Failure in a Drilled Rock Bore”.  In this decision, Justice Rofe held that Kutti Bay’s application to amend three standard patents (the Standard Patents) constituted an abuse of process, insofar as it sought to “overcome” the Court’s decisions in Jusand Nominees Pty Ltd v Rattlejack Innovations Pty Ltd [2022] FCA 540 and Jusand Nominees Pty Ltd v Rattlejack Innovations Pty Ltd [2023] FCAFC 178 (the Jusand Proceedings).  See our reports on these decisions here and here.

Background

Kutti Bay commenced proceedings alleging infringement of the Standard Patents against Rattlejack Innovations Pty Ltd, Pan Australis Pty Ltd, Murray Engineering Pty Ltd and Leigh Maurice Sutton (together, Rattlejack).  Shortly after commencing proceedings, Kutti Bay applied to amend the Standard Patents under s 105(1) of the Patents Act 1990 to correct “obvious mistakes” in the Standard Patents.  Rattlejack opposed Kutti Bay’s patent amendment application, ultimately on the basis that the amendment application (and the expert evidence intended to be relied on for the purpose of that application) gave rise to an abuse of process.

So, what was the basis for Rattlejack’s abuse of process allegation? The answer to this question requires us to delve into the previous patent disputes between these parties, which led to the decisions in the Jusand Proceedings.

In the Jusand Proceedings, Rattlejack had successfully defended Jusand’s allegations of infringement in respect of three innovation patents (the Innovation Patents).  The Federal Court (at first instance and on appeal) had also found the Innovation Patents to be invalid for lack of disclosure and support.  Relevantly:

  • the Standard Patents had the same priority date as the Innovation Patents;
  • the Standard Patents (in their unamended form) were in materially the same terms as the Innovation Patents.  The Standard Patents were also in substantially the same terms as each other; and
  • in the Jusand proceedings, the Court had made findings as to the construction of the Innovation Patents and as to the common general knowledge.

In November 2024, IP Australia re-examined all the patents in the same patent family as the Innovation Patents, including the Standard Patents.  The examiner considered that each of the claims of the Standard Patents lacked disclosure/support, for the same reasons as those identified in the Jusand Proceedings.  Given the examiner’s view, Kutti Bay considered it necessary to file the current patent amendment application to prevent revocation of the Standard Patents.

Kutti Bay relied on the evidence from three new expert witnesses, none of whom gave evidence in the Jusand Proceedings.  Justice Rofe noted that it was clear in the case of one of these experts that he did not read the Standard Patents to describe and claim the same invention that the Court found to be disclosed and claimed in the Innovation Patents.  Her Honour also noted that the conclusion of a second expert as to the routine nature of material selection was at odds with the findings in the Jusand Proceedings, and that this conclusion was only available based on an enlarged body of common general knowledge beyond what was found to exist on the evidence at first instance during the Jusand Proceedings.

Key Issues

When can a patent amendment be considered an abuse of process?

A patent amendment application may constitute an abuse of process where it seeks to re-agitate issues already finally determined by a court, undermine the effect of earlier judgments, create a risk of inconsistent findings, or unfairly prejudice another party.

Rattlejack filed an application alleging that Kutti Bay’s amendment application constituted an abuse of process to the extent that it sought to “overcome” the decisions in the Jusand Proceedings, for the following reasons:

  • The amendment application sought to re-agitate and/or challenge issues of construction determined by the Full Court.
  • The amendment application sought to invoke the Court’s statutory power in a manner that would undermine its earlier decisions.

In these circumstances, Rattlejack argue that allowing the amendment application to proceed would bring the administration of justice into disrepute, create a material risk of inconsistent findings and prejudice Rattlejack (including by exposing Rattlejack to being “twice vexed”).

Kutti Bay, however, argued that no such abuse of process arose as the proposed amendments merely corrected an “obvious mistake” in the Standard Patents, that is, a mistake which was apparent on the face of the Standard Patents and for which the correction was also obvious.

Consideration

Can a previous court decision concerning one patent affect related patents in the same patent family?

Yes.  A previous court decision concerning one patent can affect related patents in the same patent family where they are materially identical and share the same priority date.  In the Kutti Bay proceedings, Justice Rofe held that a later patent amendment based on new expert evidence would require the Court to reconsider its earlier construction of materially identical patents, amounting to an abuse of process.

Justice Rofe held that Kutti Bay’s patent amendment application was an abuse of process for the following key reasons:

  • On the basis of the evidence before it, the Court in the Jusand Proceedings had made findings as to the common general knowledge of the person skilled in the art as at the priority date.  The Court then construed the claims of the Innovation Patents, based on the findings as to the state of the common general knowledge at the priority date and assisted by the experts’ evidence as to their understanding of the claims.
  • The Standard Patents were materially identical to the Innovation Patents construed by the Court in the Jusand Proceedings.The Standard Patents and the Innovation Patents also shared the same priority date.
  • The amendment application, however, was premised on evidence which was not before the Court in the Jusand Proceedings and would require her Honour to reconsider the construction of the Standard Patents in light of this new evidence.  More particularly, Justice Rofe held at [93] and [94] that:

“Kutti Bay’s “obvious mistake” contention requires the Court to read relevantly the same specification that it construed in the Jusand Proceeding, and in order to allow the amendment, agree with the new person skilled in the art experts that a different invention is actually described and claimed, than the one previously identified and considered by the Court.

As the Respondents identify, the vice in Kutti Bay’s approach is that in order to accept the existence of an obvious mistake, the Court must accept the evidence of the new experts as to the safety system of the claimed invention.  Doing so would necessarily involve adopting a different construction of the claimed invention different from that reached in the Jusand Proceedings.”

Outcome and Implications

What happens if a patent amendment application is found to be an abuse of process?

If a patent amendment application is found to be an abuse of process, the Court may refuse the application to the extent it seeks to overcome an earlier judicial decision and may order the patentee to pay the other party’s costs.  In this case, Justice Rofe ordered Kutti Bay to pay Rattlejack’s costs.

Justice Rofe held that Kutti Bay’s application to amend the Standard Patents constituted an abuse of process, insofar as it sought to “overcome” the Court’s decisions in the Jusand Proceedings.  Justice Rofe also ordered Kutti Bay to pay Rattlejack’s costs of and incidental to its abuse of process application.

Justice Rofe’s decision is a salutary lesson for patentees: where construction of one patent in a patent family has already been the subject of a judicial decision, this construction may impact later litigation (including future amendment applications) in relation to other materially identical patents in the same family.

The proceedings continue, albeit very slowly, with the matter set down for a case management hearing in February 2027.


 

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.

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 Law “Executive 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 1000, IAM 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.

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.

Update on MSD’s Challenges to US Halozyme Patents in SC Keytruda® (Pembrolizumab) Dispute

As previously reported, since November 2024, MSD has filed a number of petitions for review with the US Patent Trial and Appeal Board (PTAB) challenging the validity of patents relating to Halozyme’s MDASE™ subcutaneous delivery platform.  Halozyme has alleged in US court proceedings that those patents are infringed by MSD’s subcutaneous pembrolizumab (Keytruda Qlex™/ Keytruda SC™).

The following developments have occurred over the last few months in relation to those petitions:

● PTAB instituted inter partes review for three of MSD’s petitions on 9 September 2026: IPR2026-00312 (10,865,400), IPR2026-00313 (11,041,149) and IPR2026-00314 (11,066,656); and

● PTAB issued final written decisions finding all challenged claims of 4 Halozyme patents invalid:

a) US 12,110,520 (PGR2025-00017, decision of 1 September 2026);

b) US 12,123,035 (PGR2025-00009, decision of 24 June 2026);

c) US 12,018,298 (PGR2025-00004, decision of 8 June 2026); and

d) US 12,152,262 (PGR2025-00006, decision of 18 May 2026).

In summary, the Halozyme patents currently the subject of US litigation and PGR or IPR proceedings are as follows:

US Patent No. PGR/IPR No. Status of PGR/IPR At Issue in US Proceeding?
11,952,600 PGR2025-00003 Patent Invalidated, 12 May 2026 Yes
12,018,298 PGR2025-00004 Patent invalidated, 8 June 2026 Yes
12,152,262 PGR2025-00006 Patent invalidated, 18 May 2026 Yes
12,123,035 PGR2025-00009 Patent Invalidated, 24 June 2026 No
12,110,520 PGR2025-00017 Patent Invalidated, 1 Sept 2026 Yes
12,060,590 PGR2025-00024 Instituted 16 Oct 2025 No
12,054,758 PGR2025-00030 Instituted 16 Oct 2025 Yes
12,049,652 PGR2025-00033 Instituted 1 Oct 2025 Yes
12,104,185 PGR2025-00039 Instituted 1 Oct 2025 Yes
12,037,618 PGR2025-00042 Instituted 13 Nov 2025 Yes
12,091,692 PGR2025-00046 Instituted 10 Oct 2025 Yes
12,077,791 PGR2025-00050 Instituted 19 Nov 2025 Yes
12,264,345 PGR2025-00052 Instituted 16 Oct 2025 Yes
12,195,773 PGR2025-00053 Instituted 19 Nov 2025 Yes
12,371,685 PGR2025-00087 Institution Denied 15 May 2026 Yes
11,066,656 IPR2026-00314 Instituted 9 September 2026 Yes
11,041,149 IPR2026-00313 Instituted 9 September 2026 Yes
10,865,400 IPR2026-00312 Instituted 9 September 2026 Yes

In December 2025, the Munich Regional Court granted Halozyme’s application for a preliminary injunction preventing MSD from distributing and offering Keytruda SC™ for sale in Germany.  The decision was based on a finding of the Court that there was imminent infringement of one of Halozyme’s European MDASE™ patents, EP 2797622, in relation to modified PH20 hyaluronidase polypeptides and compositions.  MSD has filed invalidation lawsuits in relation to EP 2797622 in four countries: Germany, the United Kingdom, the Netherlands, and France.

In July 2026, The District Court of the Hague dismissed Halozyme’s application for a preliminary injunction to prevent MSD from marketing Keytruda SC™ in Denmark and Sweden pending the outcome of substantive proceedings.

MSD’s subcutaneous formulation of pembrolizumab was approved in the US, as Keytruda Qlex™, in September 2025 across 38 indications.

Sandoz Plans Biosimilar Portfolio Expansion to 100+ by 2040 & $300M Investment in European Manufacturing Facility

On 8 September 2026, Sandoz announced that it is aiming to establish a portfolio of more than 100 biosimilars by 2040 as part of its Bio100 plan to maximise value in the “golden decade” for biosimilars.  According to Sandoz, over the next 10 years, medicines worth more than USD 650 billion dollars are set to lose exclusivity, representing an unprecedented “golden decade” for patient access to more affordable medicines.

Sandoz currently markets 13 biosimilars and, in addition to substantially increasing that number over the next 14 years, the company plans to more than double its net sales from 2025 to 2035 and achieve a core EBITDA margin above 30%.

As part of Bio100, Sandoz has also announced its plans to build a new biosimilar drug manufacturing facility in Ljubljana, Slovenia.  The project will involve a US $300 million investment in disposable fed-batch technology to expand Sandoz’s in-house manufacturing capacity and strengthen end-to-end biosimilar development and manufacturing in Europe.

This manufacturing facility is additional to previously announced investments in Slovenia.  The facility is expected to become operational in 2029 and will be located next to Sandoz’s biosimilar development centre, which opened in June 2026.

Biocon Enters 10-Year Deal with Bahiafarma and Bionovis to Supply Biosimilar Pertuzumab in Brazil

On 8 September 2026, Biocon announced that, in partnership with Brazilian state-owned pharmaceutical laboratory, Bahiafarma, and Brazilian biotechnology company, Bionovis, it has entered a 10-year contract to supply Bmab 1500, biosimilar to Roche/Genentech’s Perjeta® (pertuzumab), under Brazil’s Productive Development Partnership (PDP) program.

Under the PDP, the partnership will have exclusive access to Brazil’s public healthcare market, which accounts for approximately 70% of the country’s total market.  Biocon will receive milestone payments and a share of revenues generated from the PDP opportunity over a 10-year period.

The deal had been foreshadowed at the India-Brazil Business Forum in February 2026, along with a similar partnership between Dr Reddy’s, Bionovis and Bahiafarma to manufacture biosimilar nivolumab in Brazil.

Biocon is currently being sued by Roche/Genentech in the US in relation to Bmab 1500, with BPCIA proceedings commenced in July 2026.  The litigation arises from Biocon’s submission of an abbreviated Biologics License Application (aBLA) for Bmab 1500, the date of filing of which is confidential.  Roche/Genentech allege Biocon infringes 28 US patents for inventions related to Perjeta® and various manufacturing methods for antibody production, covering pertuzumab as well as its use and manufacture.

Genentech also filed an ITC complaint in February 2026 against Biocon’s importation of Bmab 1500 into the US, alleging that, on 18 October 2025, Biocon imported more than 17,800 units of Bmab 1500 into the US from India before it received FDA approval

Shanghai Henlius and Organon are leading the pertuzumab biosimilar race in major markets, with approvals of Poherdy® secured in the US (November 2025), EU (April 2026), and China (as Hanbeiyou®, May 2026).  BPCIA litigation filed by Roche/Genentech against Henlius/Organon was settled in January 2026 on confidential terms.

Approvals for pertuzumab biosimilars have been granted in India for Intas’ product (December 2024), Zydus’ Sigrima™ (June 2024) and Enzene’s Pertuza®/Perzea® (launched September 2025).  In Russia, Biocad’s Pertuvia™ (May 2025) and R-Pharm’s Persinthia™ (February 2026) are approved.  Litigation has been brought by Roche/Genentech against Biocad in Russia and Zydus in India.

In June 2026, EirGenix announced that it signed an agreement with an undisclosed company for the licensing and commercialisation of its pertuzumab biosimilar, EG1206A, in Japan.  This followed a 2025 global commercialisation deal with Sandoz for EG1206A, excluding Japan and a number of other countries in Asia.

Roche’s High-Dose Ocrevus® (Ocrelizumab) Given Conditional Ph 3 Waiver in India

On 4 September 2026, Business Standard reported that the Subject Expert Committee of India’s Central Drugs Standard Control Organisation (CDSCO) has given Roche a Phase 3 trial waiver for a high dose (920 mg) of Ocrevus® (ocrelizumab).  The waiver is conditional on Roche conducting Phase 4 (post-marketing) clinical trials in the Indian patient population.

CDSCO’s waiver of the Phase 3 trial requirements presents Roche with an expedited route to approval of the higher dose ocrelizumab product, which is indicated for treating relapsing and primary progressive forms of multiple sclerosis.

Roche’s Ocrevus® (300 mg) received a Phase 3 waiver in India in 2023 and was launched in that country in 2024.  The 920 mg formulation of Ocrevus® has been approved in 65 countries, including the EU (approved June 2024), UK (approved July 2024), US (approved September 2024), and Australia (approved March 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, primary completion in February 2026, with estimated completion in November 2027).  In January 2026, Samsung Bioepis announced that it had added an ocrelizumab biosimilar to its pipeline and, in July 2026, Teva and Polpharma entered into an exclusive licensing agreement for the commercialisation of Polpharma’s ocrelizumab biosimilar, PB018.

Enzene/Shin Poong’s Denosumab Biosimilar Approved in South Korea

On 4 September 2026, Daily Pharm Korea reported that South Korean-based Shin Poong Pharm has received Korean regulatory approval for Denovon™, biosimilar to Amgen’s Prolia® (denosumab).  The biosimilar is anticipated to launch at the end of 2026 following reimbursement and pricing reviews.

Shin Poong has the exclusive Korean development and commercialisation rights to Denovon™ under a 2021 agreement with India’s Enzene Biosciences (an Alkem subsidiary).  Denovon™ is a 60 mg/1 mL prefilled syringe indicated for the treatment of osteoporosis in postmenopausal individuals, glucocorticoid-induced osteoporosis, and bone loss associated with certain prostate and breast cancers.

Denovan™ joins a number of other Prolia® biosimilars already approved or on the market in Korea, including Celltrion’s Stoboclo® and Osenvelt® (approved November 2024, launched by Daewoong in March 2025), Samsung Bioepis/Boryung’s Xbryk® (approved May 2025, launched 1 August 2025), Samsung Bioepis/Hanmi’s Obodence® (launched July 2025), and mAbxience/HK inno.N’s Izambia™ and Denbrayce™ (approved 5 February 2026).

Naomi Pearce Recognised in WIPR Influential Women in IP 2026

Pearce IP Founder and CEO Naomi Pearce is one of four Australian IP professionals ranked by WIPR in Influential Women in IP 2026.  Influential Women in IP is a global ranking celebrating women whose expertise, leadership and achievements are shaping the future of IP.

WIPR describes this year’s list as:

“…an outstanding group of women whose expertise, leadership and achievements are shaping the future of intellectual property across the globe… an inspiring testament to the depth of female leadership strengthening the intellectual property system worldwide.”

Of Naomi, WIPR says:

“With more than 25 years’ experience in patent litigation, she is recognised as one of the country’s leading practitioners in the pharmaceutical sector, combining deep legal expertise with a background in molecular biology and biochemistry.

 

Under her leadership, Pearce IP has built a strong reputation for innovation, flexible working and a commitment to diversity and inclusion, with women holding the vast majority of leadership roles across the firm.”

Peter O’Sullivan, Pearce IP Deputy CEO, comments:

“Anyone who has worked with Naomi knows that her impact extends far beyond technical excellence.  She is a visionary leader who has transformed the way intellectual property services are delivered while championing flexibility, inclusion and innovation.  This recognition from WIPR is incredibly well deserved, and we are delighted to see Naomi’s achievements honoured on the global stage.”

Naomi is no stranger to recognition from World IP Review, having previously been named a WIPR Diversity Champion (2025, 2022), recognised among the Top 100 Influential Women in IP (2021), and ranked as a WIPR Leader (2025, 2024, 2023, 2022).  She has also been listed in the WIPR Leaders Patents & Trade Marks rankings since 2020, reflecting her longstanding reputation as one of Australia’s leading intellectual property practitioners.


 

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 Law “Executive 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 1000, IAM 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.

Samsung Bioepis’ IV Biosimilar Ustekinumab Approved in Japan

On 3 September 2026, Samsung Bioepis announced that its Ustekinumab BS Intravenous Infusion [NIPRO] (SB17), biosimilar to Janssen’s Stelara®, was approved in Japan as induction therapy for moderate to severely active Crohn’s disease, where other treatments are ineffective.

The approval of the IV formulation comes 9 months after Samsung Bioepis’ subcutaneous ustekinumab (45 mg syringe) was approved in Japan (December 2025).  It was subsequently launched in May 2026.  Samsung Bioepis’ biosimilar ustekinumab is being commercialised in Japan by Nipro under the terms of a June 2025 agreement.

Samsung Bioepis’ IV formulation of ustekinumab closely follows Celltrion’s IV formulation of Steqeyma® (ustekinumab), which was approved in Japan in April 2026 and launched in August 2026. Steqeyma® (IV and SC) is indicated for psoriasis and psoriatic arthritis, with the IV formulation additionally approved for Crohn’s disease.

Other ustekinumab biosimilars launched in Japan include Alvotech/Fuji Pharma’s AVT04 (May 2024) and Biocon/Yoshindo’s Ustekinumab BS Subcutaneous Injection, (May 2025).

Cipla and Qilu Partner on Biosimilar to MSD’s Keytruda® (Pembrolizumab) for US Market

On 3 September 2026, Invagen Pharmaceuticals, a wholly owned subsidiary of Cipla, announced that it has entered into a strategic partnership with China’s Qilu Pharmaceutical for the exclusive licensing and supply in the US of QL2107, biosimilar to MSD’s Keytruda® (pembrolizumab).

Under the agreement, Qilu is responsible for development, regulatory approval and supply of the product, while Cipla is responsible for US commercialisation.

Qilu commenced a Phase 3 study in January 2025 to compare the efficacy and safety of QL2107 vs Keytruda® in combination with chemotherapy in treating metastatic non-squamous non-small-cell lung cancer.  The study has an estimated primary completion date of December 2026.

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 with competition to be the first mover in major markets heating up.  Samsung Bioepis and Celltrion each applied for Korean approval of their pembrolizumab biosimilars in August 2026 (SB27 and CT-P51, respectively).  In June 2026, Samsung Bioepis claimed to be the first developer of a pembrolizumab biosimilar to announce global phase 3 trial results.  Formycon announced successful Phase 1 results in February 2026, with its US commercialisation partner, Zydus, expressing 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, Shanghai Henlius, BioNTech, 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.

Two Pearce IP Experts Earn Five Lexology Index – Australia & New Zealand 2026 Rankings

Pearce IP has achieved five individual recommendations in the Lexology Index – Australia & New Zealand 2026, with CEO and Founder Naomi Pearce and Executive Helen Macpherson both recognised across multiple categories.

CEO and Founder, Naomi Pearce, has been Ranked for:

IP – Patents,
Life Sciences, and
IP – Trade Mark Agents & Attorneys.

Executive Helen Macpherson has been Ranked for:

IP – Patents and
IP – Copyright.
 

Pearce IP is also one of only two firms with practitioners ranked across all four of these categories.

Lexology Index draws on extensive research and feedback from clients, peers and industry sources to identify leading lawyers and consulting experts across Australia, New Zealand.

Deputy CEO and Executive, Peter O’Sullivan, said:

“These recognitions reflect the depth and breadth of expertise across Pearce IP. Naomi and Helen’s recognition in multiple categories, highlights the strength of our team and our commitment to delivering exceptional IP expertise to our clients across Australia and New Zealand.”


 

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 Law “Executive 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 1000, IAM 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.

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.

Novartis Enters US$3.2M Deal with Alteogen for SC Formulation Development

On 2 September 2026, South Korean-headquartered Alteogen announced that it has entered into an option and licence agreement with Novartis for the development and commercialisation of subcutaneous (SC) formulations of Novartis products using Alteogen’s ALT-B4 drug delivery technology.  The Novartis products to be developed into SC formulations have not been disclosed.

ALT-B4 is a recombinant human hyaluronidase enzyme platform (berahyaluronidase alfa) which enables the conversion of biologics typically administered via intravenous infusion into more convenient and rapid SC formulations.

If Novartis’ multiple options under the agreement are exercised and all milestones are achieved, Alteogen is eligible to receive up to US$3.2 million, comprising option exercise fees, development and commercial milestone payments and royalties on net sales of products commercialised under the agreement.

The agreement with Novartis is the latest in a series of deals entered into by Alteogen in relation to the use of ALT-B4 in the development of subcutaneous formulations of biopharmaceutical and biosimilar products.  This includes a January 2026 agreement with Tesaro, a GSK subsidiary, for development of SC Jemperli® (dostarlimab); a 2019 exclusive licence, confirmed in June 2026, with Sanofi for development of a high dose SC formulation of Dupixent® (dupilumab), a November 2024 exclusive licence agreement with Daiichi Sankyo for SC Enhertu® (trastuzumab deruxtecan); a January 2023 agreement with Sandoz for an SC formulation of an undisclosed biosimilar; and the development of SC Keytruda® (pembrolizumab) with MSD, which has been approved including in the US as Keytruda Qlex™ (September 2025), EU (November 2025), Canada (February 2026) and Korea (May 2026).

Interest in subcutaneous formulations of antibody drug products is continuing to increase.  For example, on 21 August 2026, Huonslab announced that it secured Korean patent registration, and filed a PCT application, for its recombinant human-derived hyaluronidase-based formulation conversion platform technology (HyDIFFUZE™), applied to 11 antibody therapeutics, including pembrolizumab, bevacizumab and dupilumab.  A recent collaboration between Sandoz and Shanghai Henlius Biotech provides Sandoz with an option for a recombinant human hyaluronidase (HLXTE-Haase1001) to be used in the development of an SC biosimilar.  At the end of July 2026, it was announced that Celltrion is partnering with Korean-based G2GBIO to convert antibody drugs to SC formulations.  Meanwhile, MSD is currently engaged in litigation with Halozyme in the US and Europe in relation to Halozyme’s MDASE subcutaneous delivery technology and SC Keytruda® (pembrolizumab).

Pearce IP BioBlast® for the week ending 28 August 2026

Pearce IP provides weekly reports on global biosimilars activities in the Pearce IP BioBlast®.  Significant biosimilar activities for the week ending 28 August 2026 are set out below:


Ixekizumab

On 28 August 2026, Samsung Bioepis announced the initiation of a Phase 1 clinical trial for SB35, biosimilar to Eli Lilly’s Taltz® (ixekizumab).  The trial has an estimated… Read more here.

Omalizumab

On 25 August 2026, Celltrion announced that it has launched Omlyclo® 300 mg, biosimilar to Genentech/Novartis’ Xolair® (omalizumab), in Europe, commencing in… Read more here.

Pegfilgrastim

On 26 August 2026, Biocon announced that it received marketing authorisation from Japan’s Ministry of Health, Labour and Welfare for its pegfilgrastim biosimilar… Read more here.

Pembrolizumab

On 30 August 2026, Australia’s Minister for Health and Ageing, the Hon Mark Butler, announced that, from 1 September 2026, the listing of MSD’s Keytruda® (pembrolizumab)… Read more here.

Pertuzumab

On 26 August 2026, OncLive reported that Chia Tai Tianqing Pharmaceutical’s TQB2440 showed equivalent efficacy to its reference drug, Roche/Genentech’s Perjeta®… Read more here.

Trastuzumab emtansine

On 31 August 2026, Taiwan-based Formosa Pharmaceuticals announced that it has submitted a Clinical Trial Application (CTA) to European regulators for a pivotal… Read more here.

Ustekinumab

On 28 August 2026, the FDA announced that it approved Stelara® (ustekinumab) for the treatment of moderately to severely active ulcerative colitis (UC) in children… Read more here.

Vedolizumab

On 31 August 2026, Alvotech announced that the FDA has accepted for review its Biologics License Application (BLA) for AVT80, biosimilar to Takeda’s Entyvio®… Read more here.
 
On 26 August 2026, Takeda commenced BPCIA proceedings against Polpharma in the US District Court for the District of New Jersey in relation to Polpharma’s PB016… Read more here.

Biopharma Deals

On 28 August 2026, DualityBio announced that it has entered into a global collaboration and licence agreement with Genentech to develop antibody-drug conjugates… Read more here.

Biopharma News

On 31 August 2026, South Korean-headquartered Huonslab, a subsidiary of Huons Global, announced that it secured patent registration in Korea, and has filed an… 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 Law “Executive 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 1000, IAM 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.

Takeda Files Second Vedolizumab Biosimilar BPCIA Action with Alvotech in the Firing Line

On 1 September 2026, Takeda commenced BPCIA proceedings against Alvotech in the US District Court for the District of New Jersey in relation to Alvotech’s AVT16, biosimilar to Takeda’s Entyvio® (vedolizumab).  The litigation against Alvotech follows closely behind Takeda’s BPCIA proceedings against Polpharma filed in the same court on 26 August 2026 regarding Polpharma’s PB016 (vedolizumab).

In its complaint against Alvotech, Takeda alleges infringement of the same six US patents asserted against Polpharma relating to vedolizumab; its administration to treat inflammatory bowel disease, ulcerative colitis, and Crohn’s disease; and its formulation and method of manufacture (US patent numbers 9,663,579; 10,004,808; 12,053,526; 12,171,832; 12,544,445; and 12,622,969).

The proceedings arise from the FDA’s acceptance of Alvotech’s abbreviated Biologics License Application (aBLA) for AVT16, announced on 8 June 2026.  Takeda’s complaint discloses that Alvotech notified Takeda on 15 June 2026 of the FDA acceptance of the aBLA for AVT16 (injection for intravenous use in 300 mg single use vials) as an interchangeable biosimilar to Entyvio®.

Takeda is seeking remedies including preliminary and permanent injunctions to restrain the importation and sale of AVT16 in the US, and damages.

Under a strategic partnership entered in August 2020 and expanded in 2023, Alvotech granted to Teva the exclusive rights to commercialise AVT16 in the US.  According to the complaint filed with the US Court, in exchange for the licence, Teva agreed to pay Alvotech US$56 million, plus certain milestone payments.  Under a Product Supply Agreement, Teva also agreed to pay Alvotech’s cost of goods sold for each unit of AVT16 plus an additional percentage.

Alvotech also has a subcutaneous vedolizumab biosimilar under development (AVT80), with positive results from a PK study for the product announced in February 2026.  AVT80 is not named in the BCPIA litigation.

Other vedolizumab biosimilars are under development, including by Intas (Indian approval to conduct Phase I bioequivalence study of INTP53 in February 2025) and Samsung Bioepis (in early-stage development, global licence, development and commercialisation agreement (excluding certain Asian countries) entered with Sandoz in March 2026).

Fresenius Kabi, Advanz Pharma (Alvotech’s UK/EU commercialisation partner), Accord Healthcare (an Intas subsidiary) and Samsung Bioepis (together, Biosimilar Claimants) each commenced proceedings earlier this year in the High Court of England and Wales against Millennium Pharmaceuticals, a Takeda subsidiary. The Biosimilar Claimants are seeking to clear the way for the UK launch of their biosimilar vedolizumab products and have applied for the revocation of various Millenium patents and/or for non-infringement declarations or Arrow declarations.  The patents at issue concern dosing regimens in respect of vedolizumab (EP (UK) 3329965, 3311834 and pending patent applications EP4378484 and EP4438625)) and formulations of vedolizumab (EP (UK) 2704798 and 4403579).

New Indication Alert: AZ’s Enhertu® + Roche’s Perjeta® EU-Approved for First-Line Treatment of HER-2 Positive Breast Cancer

On 1 September 2026, AstraZeneca announced that Enhertu® (trastuzumab deruxtecan), developed in conjunction with Daiichi Sankyo, in combination with Roche/Genentech’s Perjeta® (pertuzumab) has been approved by the European Commission for the first-line treatment of adult patients with unresectable or metastatic HER2-positive breast cancer.

This is reported to be the first new regimen in more than a decade to be approved in the EU for the first line treatment of this disease and follows a CHMP recommendation in July 2026.  The Enhertu®/Perjeta® combination was approved by the FDA for the same indication in December 2025, as the first new, first-line treatment of metastatic HER2-positive breast cancer approved in a decade in the US.

Biosimilars of each of trastuzumab deruxtecan and pertuzumab are under development.  Samsung Bioepis has a trastuzumab deruxtecan biosimilar in its pipeline, while Shanghai Henlius and Organon are leading the pertuzumab biosimilar race in major markets, with approvals of Poherdy® (pertuzumab) secured in the US (November 2025), EU (April 2026), and China (as Hanbeiyou®, May 2026).  Roche/Genentech are currently suing Biocon in the US in relation to biosimilar pertuzumab (Bmab 1500).

Approvals for pertuzumab biosimilars have been granted in India for Intas’ product (December 2024), Zydus’ Sigrima™ (June 2024, subject to ongoing litigation) and Enzene’s Pertuza®/Perzea® (launched September 2025).  In Russia, Biocad’s Pertuvia™ (May 2025, subject to litigation) and R-Pharm’s Persinthia™ (February 2026) are approved.

Intas obtained Indian approval in November 2025 for a phase 1 trial comparing a combination of pertuzumab and trastuzumab with the reference product, Roche’s Phesgo®.

Huonslab Secures Korean Patent for Subcutaneous Technology Applied to 11 Antibody Formulations Including Pembrolizumab, Bevacizumab & Dupilumab

On 31 August 2026, South Korean-headquartered Huonslab, a subsidiary of Huons Global, announced that it secured patent registration in Korea, and has filed an international patent application under the Patent Cooperation Treaty (PCT), for its recombinant human-derived hyaluronidase-based formulation conversion platform technology (HyDIFFUZE™), applied to 11 antibody therapeutics.

The antibody formulations to which the HyDIFFUZE™ technology has been applied by Huonslab are pembrolizumab, bevacizumab, isatuximab, durvalumab, cetuximab, risankizumab, dupilumab, obinutuzumab, ramucirumab, donanemab and dostarlimab.

Huonslab was established in 2018 and focuses on the development of innovative drug delivery technologies.  It has a pipeline of biopharmaceutical and peptide drugs, including an early stage denosumab biosimilar, HLB3-013, in addition to its HyDIFFUZE™ technology that uses hyaluronidase to convert intravenous formulations of antibody drugs into subcutaneous injections.

Interest in subcutaneous formulations of antibody drug products is continuing to increase.  MSD is currently engaged in litigation with Halozyme in the US and Europe in relation to Halozyme’s MDASE subcutaneous delivery technology and subcutaneous Keytruda® (pembrolizumab).  A collaboration between Sandoz and Shanghai Henlius Biotech announced earlier in August 2026 provides Sandoz with an option for a recombinant human hyaluronidase (HLXTE-Haase1001) to be used in the development of a subcutaneously administered biosimilar.  At the end of July 2026, it was announced that Celltrion is partnering with Korean-based G2GBIO to convert antibody drugs to subcutaneous formulations.  Alteogen has partnered with a number of companies for the use of its ALT-B4 technology in subcutaneous formulations, including Sanofi, Daiichi Sankyo, and GSK.

Alvotech’s Subcutaneous Biosimilar Vedolizumab BLA Accepted for Review by FDA

On 31 August 2026, Alvotech announced that the FDA has accepted for review its Biologics License Application (BLA) for AVT80, biosimilar to Takeda’s Entyvio® (vedolizumab), in prefilled syringe and autoinjector forms for subcutaneous administration.  Alvotech announced positive results from a PK study for AVT80 in February 2026.

Under a partnership with Teva, Alvotech is responsible for the development and manufacture of AVT80, while Teva is responsible for its US commercialisation.  Alvotech and Teva first entered into a strategic partnership in relation to biosimilar candidates in August 2020, which was expanded in 2023.

Alvotech’s BLA for its intravenous (IV) biosimilar vedolizumab, AVT16, was the first reported vedolizumab biosimilar BLA to be accepted for review by the FDA in May 2026 (announced in June 2026).  Alvotech’s commercialisation partners for AVT16 are Teva in the US and Advanz in the UK, EU and Switzerland.

Polpharma/Fresenius Kabi’s BLA and Marketing Authorisation Application (MAA) for the vedolizumab biosimilar PB016 were accepted for review by the FDA and European Medicines Agency (EMA), respectively, in July 2026.  In both regions, PB016 is delivered in a lyophilised vial for IV administration and is indicated for the treatment of adults with moderately to severely active ulcerative colitis and Crohn’s disease.

Other vedolizumab biosimilars are also under development, including by Intas (Indian approval to conduct Phase I bioequivalence study of INTP53 in February 2025) and Samsung Bioepis (in early-stage development, global licence, development and commercialisation agreement (excluding certain Asian countries) entered with Sandoz in March 2026).

Litigation regarding vedolizumab biosimilars is currently underway in the UK (court applications to revoke Takeda/Millenium patents relating to vedolizumab filed by Fresenius Kabi, Advanz Pharma, Accord Healthcare and Samsung Bioepis earlier this year) and the US (BPCIA litigation commenced by Takeda against Polpharma in August 2026).

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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