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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 week ending 3 July 2026

Pearce IP provides weekly reports on global biosimilars activities in the Pearce IP BioBlast®. Significant biosimilar activities for the week ending 3 July 2026 are set out below:


Nivolumab

On 30 June 2026, Nordic-based Orion Pharma announced it has entered into an agreement with India-headquartered Shilpa Biologicals, a subsidiary of Shilpa Medicare… Read more here.

Omalizumab

On 1 July 2026, Seoul Economic Daily reported that Celltrion has launched its new Omlyclo® (omalizumab) Pen Injection 150mg, an autoinjector formulation designed for… Read more here.

Pembrolizumab

On 29 June 2026, Samsung Bioepis announced positive results from global Phase 1 and Phase 3 clinical trials, confirming equivalence of SB27 (pembrolizumab) with the… Read more here.

Pertuzumab

30 June 2026 | JP | EirGenix Signs Agreement for Commercialisation of Pertuzumab Biosimilar in Japan
On 30 June 2026, EirGenix announced that it has signed an agreement for the licensing and commercialisation of EG1206A, biosimilar to Roche’s Perjeta® (pertuzumab)… Read more here.

Ranibizumab

1 July 2026 | US | Samsung Bioepis/Harrow Relaunch Ranibizumab Biosimilar in US
On 1 July 2026, Samsung Bioepis and Harrow announced the relaunch of Byooviz® (ranibizumab), biosimilar to Genentech’s Lucentis®, in the US. The relaunch follows the… Read more here.


Rituximab

1 July 2026 | US | Celltrion’s Truxima® Becomes First Interchangeable Rituximab Biosimilar in US
On 1 July 2026, Celltrion announced that the FDA has granted interchangeability status to Truxima®, biosimilar to Genentech/Biogen’s Rituxan®, making it the first rituximab biosimilar… Read more here.

Semaglutide

29 June 2026 | CA | Apotex Secures First Canadian-Approved Generic Semaglutide for Weight Loss
On 29 June 2026, Health Canada approved Apotex’s Sevmia™, generic equivalent of Novo Nordisk’s Wegovy® (semaglutide).  Sevmia™ is the first generic semaglutide product… Read more here.

Ustekinumab, Insulin degludec, Rozanolixizumab, Tezepelumab

On 1 July 2026, Australia’s Pharmaceutical Benefits Scheme published its Summary of Changes, which includes a newly PBS-listed ustekinumab biosimilar and new or expanded… Read more here.

Biopharma News

On 1 July 2026, The Korea Biomedical Review reported that Samsung Epis Holdings has opened and commenced operating its new research and development centre in Beijing… 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.

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 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.

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.

Celltrion Secures Preferred Formulary Status for its Biosimilar to Roche/Genentech’s Avastin® (Bevacizumab) with 2 US PBMs

On 7 July 2026, Celltrion announced that it has successfully secured formulary listings for Vegzelma™, biosimilar to Roche/Genentech’s Avastin® (bevacizumab), with two major pharmacy benefit managers (PBMs) in the US.

Vegzelma™ was listed as a preferred drug on the government and commercial insurance formularies of Express Scripts (ESI) and on the government insurance formulary of Optum.  Reimbursement coverage for ESI and Optum’s government insurances came into effect on 1 July 2026, with coverage for ESI’s commercial insurance expected to come into effect in January 2027.

Vegzelma™ was approved by the FDA in September 2022.  According to Celltrion’s announcement, as of May 2026, Vegzelma™ had captured over 10% market share of the US bevacizumab sector through the open market, and it has now “secured coverage across more than 35% of the US insurance market” through the PBM formulary listings.

There are currently five other bevacizumab biosimilars approved in the US: Amgen’s Mvasi® (September 2017), Pfizer’s Zirabev® (June 2019), Amneal’s Alymsys® (April 2022), Bio-Thera/Sandoz’s Avzivi® (December 2023) and Biocon Biologics’ Jobevne™ (April 2025).  More recently, on 13 January 2026, Shanghai Henlius Biotech announced that a Biologics Licence Application for its bevacizumab biosimilar, HLX04, was accepted for review by the FDA.

Novartis to Acquire UK-Based Myricx Bio in USD1.5B Deal Strengthening Novartis’ Oncology Pipeline

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 biotechnology company developing antibody-drug conjugates (ADCs) using N-myristoyltransferase inhibitor (NMTi) payloads.  Myricx has two lead assets under development, with potential across multiple solid tumour settings.

The transaction is expected to close in H2 2026, subject to closing conditions and regulatory approvals.  Under the terms of the agreement, Novartis will pay Myricx Bio USD1.1 billion cash up front, with up to USD400 million in potential milestone payments.

According to the companies, the acquisition of Myricx Bio will strengthen Novartis’ oncology pipeline, as ADCs have become an important part of cancer treatment.  Fiona Marshall, the President of Biomedical Research at Novartis stated that the “proposed acquisition reflects our strategy to scale innovative platforms, as we have with radioligand therapies, to deliver more durable, transformative treatments for patients.”

In February 2024, Novartis announced that it had agreed to acquire MorphoSys AG, a biopharmaceutical company focused on oncology medicines, for around €2.7B.

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 Keytruda® (pembrolizumab).  The amendment reduces the number of trial participants from about 600 to around 220 as a result of “consultation with regulatory authorities”.

The 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 amendment to its Phase 3 trial plan comes a week after Samsung Bioepis announced positive results from its global Phase1 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.

Colour Change, Course Change: v2food Overturns Patent Opposition

 

Date of decision: 23 January 2026 (APO); 15 April 2026 (FCA)
Body: Australian Patent Office; Federal Court of Australia
Adjudicator:
Delegate Felix White (APO); Perram J (FCA)

Introduction

These decisions concern Australian Patent Application No. 2021247417 (“Food Colouring Agents”), in the name of v2food Pty Ltd.  The application relates to the use of phycoerythrin – a protein obtainable from algae including Porphyridium and Rhodomonas species – as a colouring agent in meat mimetic (plant-based meat) products, capable of mimicking the colour change that occurs when animal meat is cooked.  The matter proceeded first before a delegate of the Commissioner of Patents at the Australian Patent Office (APO), and then on appeal to the Federal Court of Australia before Justice Perram.

Background

v2food’s patent application describes the application of phycoerythrin to impart a pink or red colour to meat mimetic products that visually changes upon cooking to an internal temperature of approximately 50–95°C, thereby closely replicating the appearance of cooking real meat.  Existing plant-based colouring agents such as beetroot extract are noted to lack this heat-responsive colour-change property.

The application was accepted in August 2023 and Provectus Algae Pty Ltd filed a notice of opposition in November 2023, raising multiple grounds of opposition including lack of novelty, inventive step, clarity, best method, sufficiency and support.  The opposition was heard by Delegate Felix White in Melbourne in May 2025 (Provectus Algae Pty Ltd v v2food Pty Ltd [2026] APO 1).

Key Issues

At the APO, the Delegate narrowed the live issues to novelty, inventive step, clarity, best method, sufficiency, and support.  Priority was also contested, as its validity affected which prior art documents could be relied upon.

The Delegate found that the priority date of 31 March 2020 was validly claimed, which limited the available prior art.  On novelty, the Delegate found that none of the cited documents contained a clear and unmistakeable direction to use phycoerythrin derived specifically from Porphyridium or Rhodomonas in meat mimetics, and so the opposition on the novelty ground failed.  All other grounds of opposition also failed, except inventive step.

On inventive step, the critical question became whether a skilled worker in the field of meat mimetics, equipped with common general knowledge and either of two single prior art documents – D17 (concerning Rhodomonas salina phycoerythrin) or D18 (concerning, relevantly, Porphyridium cruentum phycoerythrin) – would have been led, as a matter of routine, to use those proteins to achieve a cooking-dependent colour change in meat mimetics.  The decision is notable because the Delegate treated D17 and D18 as single pieces of prior art information under post-Raising the Bar s 7(3)(a), even though they were outside the skilled worker’s technical field.  Each document disclosed that the relevant phycoerythrins lose absorption/emission in the 500-600 nm region at temperatures of approximately 60-80°C in aqueous/in vitro conditions.

Considerations

Person Skilled in the Art

A central issue in the APO decision was identifying the appropriate “person skilled in the art” — the hypothetical, non-inventive expert by whose knowledge novelty and inventive step are assessed.  The Delegate made an important distinction between the skilled person for construing the specification (relevant to sufficiency and support) and the skilled person for assessing novelty and inventive step.  Because the invention married two different technical fields — algal biochemistry and food technology — these could be different people.

From this, the Delegate drew a deliberate distinction between two different skilled person constructs:

  • For construing the specification and assessing sufficiency and support, the skilled addressee would need expertise in both algal protein biochemistry and food technology, because understanding the full disclosure of the specification required knowledge of both fields.
  • For assessing novelty and inventive step, the relevant skilled worker was confined to the field of food technology, specifically meat mimetics, because that is the field to which the invention is directed — the problem being solved (replicating the colour change of cooking meat) is a food technology problem, not an algal science problem.

This distinction limited the common general knowledge available for the inventive step analysis to what a meat mimetics specialist would know; it did not itself import algal biology or marine science as common general knowledge.  However, the Delegate also held that, under the post-Raising the Bar form of s 7(3)(a), a single prior art document may be considered with common general knowledge even if the document is outside the skilled worker’s technical field.  The distinction also shaped the weight given to the expert evidence, with the algal biotechnologists’ evidence carrying less weight on inventive step, and the applicant’s meat mimetics expert, Dr Ha, treated as the best placed witness for that purpose.

The Delegate accepted that the problem of providing a meat analogue with a realistic cooking-related colour change was part of common general knowledge in the field, referencing a 2019 review article (D39) on commercially available meat analogue products.

Inventive Step

The core of the lack of inventive step argument pressed by the Opponent at the oral hearing was that the choice of Porphyridium or Rhodomonas phycoerythrin to provide a colour change to meat mimetics was an obvious solution to the problem of providing a meat mimetic with a suitable indicator for colour change upon cooking, based on the known absorbance and denaturation properties of these proteins.  In essence, the Opponent asserted that the route taken by the inventors, as disclosed in the specification, was an obvious one.

The Delegate found that it was not objectively surprising that phycoerythrin would work as a colouring agent in meat mimetics.  The Delegate noted that the problem was to find a red pigment that loses colour at cooking temperatures. Prior art documents D17 and D18 showed that phycoerythrin from Rhodomonas and Porphyridium had that property, losing colour in the relevant temperature range. Although those experiments were performed in solution, the Delegate considered that sufficiently close to the wet or semi-solid environment of a meat mimetic matrix.

The Delegate was not persuaded by v2food’s arguments that the underlying mechanism was different from meat — thermal denaturation rather than oxidation — because the skilled person was a food technologist looking for colour-change performance, not a scientist focused on theoretical mechanisms.  There was also no persuasive evidence that the meat mimetic matrix would prevent phycoerythrin from denaturing and changing colour.

The Delegate gave less weight to the views of the algal biotechnology experts because the relevant skilled person for inventive step was a meat mimetics/food technology specialist, not an algal biotechnologist.

Accordingly, the Delegate held that the skilled worker would have had a reasonable expectation that phycoerythrin from Porphyridium or Rhodomonas “may well” work to provide cooking-related colour change in meat mimetics.  The need for further validation did not avoid obviousness, because Australian inventive step law does not require certainty of success — only an expectation that the proposed approach may well succeed.

The Delegate concluded that all 24 claims lacked an inventive step in light of common general knowledge combined with either D17 or D18 as single prior art documents.  A key aspect of the APO decision was the Delegate’s willingness to rely on single technical papers outside the skilled worker’s field as s 7(3)(a) information.

Clarity

The opponent argued that claim 1 contained internal inconsistencies because not all Porphyridium species produce red phycoerythrin and not all phycoerythrins change colour across the full 50–95°C range claimed.  The Delegate rejected this argument, finding that the claim was self-limiting — phycoerythrins that did not meet the stated performance criteria (colour change within the specified temperature range) simply fell outside the claim’s scope, and a skilled worker could readily determine whether any given phycoerythrin satisfied those criteria.

Best Method

The opponent argued that v2food had withheld a better method of formulating phycoerythrin into meat mimetics than that disclosed in the specification, pointing to an internal email describing early experiments with Porphyridium purpureum phycoerythrin.  The Delegate found that the language of the email — referring to having “had a play” and results “taking it in the right direction” — clearly indicated these were preliminary experiments rather than a superior undisclosed method, and the specification’s examples were broadly consistent with those experiments in any event.

Sufficiency

The opponent contended that the wide range of variables in the claims — different phycoerythrin types, different Porphyridium and Rhodomonas species, and different meat mimetic matrices — combined with expert evidence that validation would be needed for each product, indicated an undue burden on the skilled worker.  The Delegate applied the Jusand approach of only interrogating variables “relevant” to the technical contribution, finding that the core technical contribution was simply the ability to achieve a cooking-dependent colour change, and that variability in product formulation or phycoerythrin type did not undermine that contribution across the claim scope.

Support

The opponent’s submissions on support were brief, essentially arguing that because the claims lacked novelty there was no technical contribution and therefore the claims could not correspond to any technical contribution.  Having found that the application did have a genuine technical contribution — the use of suitable phycoerythrins from Porphyridium and/or Rhodomonas to confer a cooking-dependent colour change to meat mimetics — and that this was properly reflected in the claims, the Delegate found the support ground was not made out.

Conclusion

In the APO decision, the opposition succeeded because all claims were found to lack an inventive step.  The Delegate invited submissions on whether v2food should be given an opportunity to amend and made no award of costs.  V2food appealed the decision.

The Appeal

On appeal to the Federal Court (v2food Pty Ltd v Provectus Algae Pty Ltd [2026] FCA 436), the outcome changed significantly.  Provectus filed a submitting notice in March 2026, but had filed no evidence in the Federal Court proceedings.  The Commissioner similarly declined to take an active role in the appeal proceedings.  As a result, there was no evidentiary material before the Court capable of supporting any ground of opposition.

Perram J applied well-established principles confirming that an appeal under section 60(4) proceeds as a hearing de novo, with the opponent bearing the onus of establishing grounds of opposition.  Where, as was the case here, the opponent has filed no evidence and taken no active part, there is no basis on which the opposition can be upheld.  His Honour distinguished CSIRO v Urrbrae Foods [2025] FCA 1591, where Beach J had invited the patent applicant to file additional evidence because the delegate’s finding of invalidity had rested on a gap in the applicant’s own evidence rather than the opponent’s evidence.  In this matter, the invalidity finding at the APO arose from Provectus’s evidence on inventive step – evidence that was absent before the Court on appeal.  Perram J therefore did not need to, and did not, engage with v2food’s substantive criticisms of the Delegate’s inventive step reasoning.

Outcome

The Federal Court allowed the appeal, set aside the Delegate’s decision of 23 January 2026, dismissed Provectus’s opposition, and ordered that the patent application proceed to grant.  No order as to costs was made, consistent with the orders proposed by v2food.

Implications

The Federal Court decision reinforces an important principle in Australian patent opposition appeal practice, namely, where an opponent files a submitting notice and adduces no evidence on appeal, that will generally be fatal to the opposition if the delegate’s adverse finding depended on the opponent’s evidence: the opponent bears the onus and cannot discharge it without evidence.

For patentees and opponents in the food technology and alternative protein sectors, the outcome of these decisions is commercially significant but should be framed carefully.  v2food’s application proceeded to grant, but the Federal Court outcome was the result of a procedural decision rather than a substantive review of the Delegate’s inventive step analysis.  Perram J also confirmed that grant does not foreclose future validity challenges, leaving open the possibility of revocation proceedings.  The APO decision nevertheless remains useful because it illustrates how single scientific papers outside a skilled worker’s field may be used as s 7(3)(a) prior art in a post-Raising the Bar inventive step analysis.


 

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.

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 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.

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.

 

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.

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.

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.

Pearce IP the Only AU–NZ IP Firm Ranked Top Specialist Firm by Australasian Lawyer and NZ Lawyer

Pearce IP is proud to be recognised by Australasian Lawyer and NZ Lawyer as a Top Specialist Firm in Intellectual Property for 2026 – marking its second consecutive year of recognition. Pearce IP was one of only six firms ranked in intellectual property, and the only IP firm operating across both Australia and New Zealand.

According to Australasian Lawyer and NZ Lawyer:

“Specialist firms typically offer deeper expertise, more targeted advice and greater experience in high-stakes or complex matters within their niche than generalist practices.”

Australasian Lawyer and NZ Lawyer noted a clear set of shared qualities among the recognised top specialist law firms, including Pearce IP:

Deliberate focus. These firms actively decided to go deep rather than broad and held to that decision under pressure. In each case, the decision to focus was the decision to become excellent.

Outcome-aligned culture. Financial results in these firms are a product of doing the work well, not the primary target the work is aimed at.

Trust as infrastructure. Long-standing client relationships are common among these firms. Trust is not a soft value – it is the source of the firm’s competitive advantage.

Adaptability within specialism. All firms navigated significant external disruption in the past 12 months. What distinguished these firms was that they met disruption without abandoning what made them trusted in the first place.

Pearce IP’s Founder and CEO Naomi Pearce says:

“We’re proud to again be recognised again as a Top Specialist Firm for 2026. In life sciences sectors, where innovation is both highly complex and deeply regulated, specialist intellectual property advice is critical. Our clients rely on us to protect breakthrough technologies and navigate rapidly evolving scientific and legal landscapes with clarity and precision.”

Deputy CEO Peter O’Sullivan says:

“At the heart of this recognition is our team. We’ve worked hard to create an environment where talented specialists can do their best work, supported by strong leadership and a clear focus on our clients. I’m incredibly proud of what we’ve achieved together and what this recognition represents.”


 

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.

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 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.

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.

 

Prestige Biopharma Signs Strategic MOU with Charles River Laboratories for Biopharmaceutical Development and Manufacturing

On 2 July 2026, Singaporean-headquartered Prestige Biopharma announced that it had signed a memorandum of understanding (MOU) with US-based Charles River Laboratories to collaborate on biopharmaceutical development, testing and manufacturing.

The collaboration will create an end-to-end service for the development and commercialisation of biosimilars and novel antibody therapies, by integrating Charles River’s discovery, pre-clinical and analytical testing with Prestige’s development and Contract Development and Manufacturing Organisation (CDMO) capabilities.

Additionally, the collaboration initiates a joint global business development strategy.  Under the terms of the MOU, Charles River will refer clients requiring biopharmaceutical process development and manufacturing to Prestige, while Prestige will connect clients in need of early-stage discovery, preclinical toxicology and bioanalytical services to Charles River.  The companies plan to utilise joint marketing initiatives to increase their global presence.

In 2023, Prestige Biologics entered into a non-binding MOU with a Dr. Reddy’s Laboratories subsidiary for the manufacturing, packaging and distribution of Dr. Reddy’s extensive biopharmaceutical pipeline in South Korea.

Samsung Epis Opens First Research and Development Centre in China

On 1 July 2026, The Korea Biomedical Review reported that Samsung Epis Holdings has opened and commenced operating its new research and development centre in Beijing.  The establishment of the new R&D centre was first announced by Samsung Epis on 29 May 2026.

The R&D centre is operated by Samsung Bioepis (China), a wholly owned subsidiary of Samsung Epis Holdings, and will serve as a global R&D hub supported by “world-class scientific talent and advanced technological infrastructure in China”.  The centre will have a strategic focus on securing antibody-drug conjugate (ADC) technology platforms and strengthening Samsung’s capabilities in new drug development.

New PBS Listings for Biosimilar Ustekinumab, Insulin Degludec, Rozanolixizumab & Tezepelumab Take Effect

On 1 July 2026, Australia’s Pharmaceutical Benefits Scheme published its Summary of Changes, which includes a newly PBS-listed ustekinumab biosimilar and new or expanded PBS-listings for a number of biopharmaceuticals.

The newly PBS-listed ustekinumab biosimilar is Amgen’s Wezlana®, biosimilar to Janssen’s Stelara®, which is PBS-listed for the treatment of inflammatory conditions.  Wezlana® was approved by the TGA in January 2024 and was recommended by PBAC for PBS listing in April 2024, although Amgen did not proceed with the PBS listing at that time.  Amgen requested PBS listing of Wezlana® be put back on the agenda at the March 2026 PBAC meeting and PBAC then extended its March 2024 recommendation for a further 12 months.

The only other ustekinumab biosimilar currently PBS-listed in Australia is Celltrion’s Steqeyma® (1 August 2025).  Samsung Bioepis’ Epyztek® (ustekinumab) was recommended for PBS listing at PBAC’s March 2025 meeting, but has not yet progressed to PBS listing, pending lodgement of required documentation.  Sandoz’s Ardelya® (ustekinumab) was recommended for PBS listing at the March 2026 PBAC meeting but is yet to receive marketing approval in Australia.

The biopharmaceuticals PBS-listed from 1 July 2026 include:

In addition, Roche’s PBS listing for Perjeta® (pertuzumab) has been expanded to include the treatment of high-risk HER2+ early breast cancer.  Perjeta® was first approved by the TGA in May 2016 and the new indication was recommended by the PBAC for reimbursement in March 2025.

Celltrion’s Truxima® Becomes First Interchangeable Rituximab Biosimilar in US

On 1 July 2026, Celltrion announced that the FDA has granted interchangeability status to Truxima®, biosimilar to Genentech/Biogen’s Rituxan®, making it the first rituximab biosimilar in the US to earn this designation.  As the first interchangeable rituximab biosimilar in the US, Truxima® has a 1-year exclusivity period, during which the FDA cannot approve subsequent interchangeable versions of Rituxan®.

Truxima® was launched in the US in May 2020 and is approved for all non-paediatric indications of Rituxan®, including non-Hodgkin lymphoma, chronic lymphocytic leukemia, rheumatoid arthritis, and microscopic polyangiitis.

Rituxan® was first approved in the US on 26 November 1997 and was one of the first mAbs to become biosimilar.  In addition to Truxima®, Amgen/Allergan’s Riabni® (approved December 2020) and Pfizer’s Ruxience® (launched January 2020) are the only rituximab biosimilars approved in the US market, with Dr Reddy’s biosimilar rituximab being knocked back by the FDA in April 2024.

Samsung Bioepis/Harrow Relaunch Ranibizumab Biosimilar in US

On 1 July 2026, Samsung Bioepis and Harrow announced the relaunch of Byooviz® (ranibizumab), biosimilar to Genentech’s Lucentis®, in the US.

The relaunch follows the transition of Biogen’s commercialisation rights for biosimilar ranibizumab (and biosimilar aflibercept) back to Samsung Bioepis after Biogen terminated a November 2019 agreement with Samsung Bioepis for the US and Canada.  Samsung Bioepis entered into a partnership with Harrow in July 2025 for the US commercialisation of Byooviz® (and Opuviz® (aflibercept)) on full return of the commercial rights.

Byooviz® was approved in the US in September 2021 for the treatment of patients with neovascular (wet) age-related macular degeneration, macular oedema following retinal vein occlusion, and myopic choroidal neovascularisation.  It was originally launched in the US in June 2022 and was granted interchangeability designation by the FDA in October 2023.

The following ranibizumab biosimilars are also approved in the US: Sandoz’s Cimerli® (August 2022, rights acquired by Sandoz from Coherus in March 2024), Formycon’s Nufymco® (December 2025) and Lupin’s Ranluspec® (June 2026).

Celltrion Launches Omalizumab Autoinjector in Korea

On 1 July 2026, Seoul Economic Daily reported that Celltrion has launched its new Omlyclo® (omalizumab) Pen Injection 150mg, an autoinjector formulation designed for the treatment of allergic asthma and chronic idiopathic urticaria.

Celltrion announced the Korean approval of the autoinjector presentation of Omlyclo®, biosimilar to Novartis’ Xolair®, in December 2025.  The launch comes three months after Celltrion’s Korean launch of its high dose (300 mg) Omlyclo® formulation.

Celltrion’s Omlyclo® (CT-P39) is currently the only omalizumab biosimilar on the market anywhere in the world. Omlyclo® was approved in the US in March 2025 (75 mg/0.5ml and 150 mg/ml PFS forms) and in December 2025 (300mg formulation).  Celltrion commenced its European rollout of Omlyclo® with the launch of the product in Norway in September 2025, and completed its launch in major European countries including Germany, Spain, the UK and France in November 2025.  In late November 2025, Celltrion announced that it launched Omlyclo® in Brazil, while in January 2026, high dose Omlyclo® (PFS and autoinjector) was approved in Canada.

Kashiv BioSciences/Alvotech are likely to be the next companies with an approved omalizumab biosimilar on the market.  Under an exclusive licensing agreement with Kashiv entered in October 2023, Alvotech holds the commercialisation rights to ADL-018 (also referred to as AVT23) in Canada, together with the European Economic Area, UK, Switzerland, Australia and New Zealand.  An application for ADL-018 was accepted for review by Health Canada in June 2026 and marketing applications for AVT23 were accepted by the UK’s MHRA in March 2025 and by the European Medicines Agency in October 2025.  Kashiv has entered into agreements for commercialisation of ADL-018 with Cristália for LATAM (August 2025) and MS Pharma for MENA markets (August 2025).

Omalizumab biosimilars are also in development by at least CuraTeQ (Ph 3 study results announced April 2026) and Teva (acceptance for review of biosimilar omalizumab applications in US and EU announced March 2026).

Pearce IP BioBlast® for the week ending 26 June 2026

Pearce IP provides weekly reports on global biosimilars activities in the Pearce IP BioBlast®. Significant biosimilar activities for the week ending 26 June 2026 are set out below:


Denosumab

On 23 June 2026, Organon and Shanghai Henlius announced the Canadian launch of Bildyos® (denosumab injection, 60 mg/1 mL) and Tuzemty® (denosumab injection… Read more here.

Denosumab, Pegfilgrastim, Ustekinumab

On 26 June 2026, the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) announced the outcomes of its June 2026 meeting, including positive… Read more here.

Golimumab

On 19 June 2026, Janssen filed a BPCIA complaint against Alvotech in the US District Court for the Eastern District of Virginia alleging that Alvotech’s golimumab biosimilars, AVT05 SC… Read more here.

Pembrolizumab

On 25 June 2026, MSD announced that the FDA has approved each of Keytruda® (pembrolizumab) and Keytruda Qlex™ (pembrolizumab and berahyaluronidase alfa-pmph), in… Read more here.

Vusolimogene oderparepvec

On 26 June 2026, Replimune announced that its third submission of the Biologics License Application (BLA) for RP1 (vusolimogene oderparepvec) in combination with BMS’ Opdivo®… Read more here.

Biopharma News

On 22 June 2026, AbbVie and Apogee Therapeutics announced that they have entered into a definitive agreement for the acquisition by AbbVie of all outstanding shares of Apogee… 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.

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 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.

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.

EirGenix Signs Agreement for Commercialisation of Pertuzumab Biosimilar in Japan

On 30 June 2026, EirGenix announced that it has signed an agreement for the licensing and commercialisation of EG1206A, biosimilar to Roche’s Perjeta® (pertuzumab), in Japan.  The partner to the deal has not been identified but is said to be a “leading Japanese pharmaceutical company”.

Under the agreement, EirGenix will provide CMC-related know-how and product-related information necessary for regulatory activities, while remaining responsible for product development, manufacturing, and commercial supply.  The Japanese partner will lead regulatory approval activities and commercialisation in Japan.

According to EirGenix, a pharmacokinetic clinical study for EG1206A has been completed and the biosimilar has received positive feedback from both the FDA and the European Medicines Agency regarding the feasibility of an abbreviated development pathway, including the waiver of Phase 3 comparative efficacy trials.

In 2025, EirGenix entered into a global commercialisation deal with Sandoz for EG1206A which excluded Japan and a number of other countries in Asia.  This followed a 2023 deal between the same companies relating to EirGenix’s trastuzumab biosimilar Herwenda® (referencing Genentech’s Herceptin®).

Henlius and Organon are leading the pertuzumab biosimilar race in major markets, with approvals of Poherdy® secured in the US, EU, and China (as Hanbeiyou®).  Approvals for pertuzumab biosimilars have been granted in India for Intas’ product (December 2024), Zydus’ Sigrima™ (June 2024subject to ongoing litigation) and Enzene’s Pertuza®/Perzea® (launched September 2025).  In Russia, Biocad’s Pertuvia™ (May 2025) and R-Pharm’s Persinthia™ (February 2026) are approved.

Orion Pharma Partners with Shilpa for Biosimilar Nivolumab in Europe

On 30 June 2026, Nordic-based Orion Pharma announced it has entered into an agreement with India-headquartered Shilpa Biologicals, a subsidiary of Shilpa Medicare, to commercialise in Europe Shilpa’s intravenous nivolumab biosimilar, which is currently under development.

Under the agreement, Orion will have the exclusive right to distribute, market and sell Shilpa’s biosimilar nivolumab in Europe, while Shilpa will supply the product to Orion and is entitled to receive certain confidential development and regulatory milestone payments.

BMS’ originator nivolumab (Opdivo®) is approved in Europe for various indications including:

A number of other 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, NeuClone’s candidate and Zydus’ ZRCr-4276.

Orion has an existing distribution agreement for Europe with CuraTeQ in relation to unidentified biosimilars, while Shilpa announced a commercialisation deal with SteinCares for an undisclosed biosimilar in Latin America in February 2026.

Strengthening Our Trade Marks Capability | Sarah Ramsey-Caudle Joins Pearce IP

Pearce IP continues to deliver on its commitment to set the standard for excellence in the provision of legal and intellectual property services across Australia and New Zealand with the appointment of Sarah Ramsey-Caudle as Senior Associate, Lawyer & Trade Mark Attorney.

Sarah joins Pearce IP with nearly a decade of experience advising Australian, New Zealand and international clients on the protection, enforcement and commercialisation of brands.  She advises on all aspects of trade mark law, from clearance and filing strategies through to portfolio management, prosecution, oppositions, non-use proceedings, infringement disputes, enforcement actions, copyright, licensing and intellectual property commercialisation.  Sarah regularly manages Australian and international trade mark portfolios and has experience in contentious matters before the Australian Trade Marks Office and the Federal Court of Australia, combining technical expertise with commercially focused advice to help clients build, protect and maximise the value of their intellectual property.

Having worked with some of the world’s most recognised consumer brands, Sarah has particular expertise advising clients in the cosmetics, fashion, retail, food and beverage, and supply chain sectors.  She is known for providing responsive, pragmatic advice that aligns intellectual property strategies with broader business objectives.

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

“We are delighted to welcome Sarah to Pearce IP. She brings exceptional technical expertise, extensive experience managing valuable brand portfolios, and a practical commercial approach that aligns perfectly with how we support our clients.  Sarah’s appointment reflects our continued investment in providing market-leading trade mark expertise across Australia and New Zealand.”

Sarah Ramsey-Caudle said:

“Trade marks are one of a business’ most valuable assets because they are how customers recognise, connect with and trust a brand.  Helping businesses protect and capitalise on those assets is what makes working in this area so dynamic and rewarding.  I’m delighted to join Pearce IP and work alongside a team recognised for its specialist expertise and commitment to delivering exceptional service and outcomes for our clients.  I look forward to partnering with clients to help them build, protect and maximise the value of their brands through practical, commercially focused IP strategies.”

To learn more about Sarah and her experience, view her profile or contact her directly at sarah.ramseycaudle@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.

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 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.

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.

 

Apotex Secures First Canadian-Approved Generic Semaglutide for Weight Loss

On 29 June 2026, Health Canada approved Apotex’s Sevmia™, generic equivalent of Novo Nordisk’s Wegovy® (semaglutide).  Sevmia™ is the first generic semaglutide product approved in Canada for chronic weight management.

Sevmia™ was developed in partnership with Orbicular Pharmaceutical Technologies and is approved as a solution for subcutaneous injection in a pre-filled pen (4 mg/pen; 1.34 mg/mL).  It is indicated for once-weekly treatment of patients aged 12 years and over, as a supplement to a reduced calorie diet and increased physical acitivity for chronic weight management.

Generic semaglutide products have previously been approved in Canada only for the treatment of type 2 diabetes.  Apotex’s Apo-Semaglutide Injection™ was approved on 1 May 2026 and launched 14 May 2026, while Dr Reddy’s Laboratories’ generic semaglutide injection was approved on 29 April 2026 and also launched in Canada on 14 May 2026.

Health Canada is reviewing numerous submissions for generic semaglutide, including applications by AA Pharma, Aspen Pharmacare, Teva, Taro Pharmaceuticals, Zydus Lifesciences and Sandoz (which is planning a 2026 generic semaglutide launch in Canada).  Further generic semaglutide approvals and launches are therefore expected in Canada in the coming months.

Samsung Bioepis Announces Positive Results from Global Ph 1/3 Biosimilar Pembrolizumab Studies

On 29 June 2026, Samsung Bioepis announced positive results from global Phase 1 and Phase 3 clinical trials, confirming equivalence of SB27 (pembrolizumab) with the reference product, MSD’s Keytruda®.  According to Samsung Bioepis, it is the first developer of a pembrolizumab biosimilar to announce global phase 3 clinical trial results.

The news follows reports published on 5 May 2026 announcing positive preliminary Phase 1 data for SB27, which were subsequently withdrawn from a number of news sites.  The Phase 1 and Phase 3 trials were both commenced in 2024, in an “overlap strategy” designed to accelerate SB27 development, with the studies expected to be completed by the end of 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.  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, Celltrion, 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.

Replimune’s Third Submission for Vusolimogene Oderparepvec Plus Nivolumab Accepted for Review by FDA

On 26 June 2026, Replimune announced that its third submission of the Biologics License Application (BLA) for RP1 (vusolimogene oderparepvec) in combination with BMS’ Opdivo® (nivolumab) for the treatment of advanced melanoma has been accepted for review by the FDA.  A target date for the FDA’s decision has been set for 2 August 2026.

Replimune’s plan for resubmission was reported in May 2026, following the rejection of two earlier submissions in July 2025 (first Complete Response Letter (CRL) issued in response to a November 2024 BLA submission) and April 2026 (second CRL issued in response to an October 2025 BLA submission).

In May 2026, the FDA indicated it would treat Replimume’s BLA resubmission as an urgent matter upon receipt and would prioritise its review in recognition of the significant unmet need for patients in the advanced melanoma community.

CHMP Positive Opinions for Ascend’s Biosimilar Denosumab & Qilu Pharma’s Biosimilar Pegfilgrastim; Extended Indications Including for Janssen’s Ustekinumab

On 26 June 2026, the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) announced the outcomes of its June 2026 meeting, including positive opinions for two biosimilars and recommended indication extensions for a number of biopharmaceuticals.

Ascend GmbH (a subsidiary of Alkem Laboratories) secured a CHMP positive opinion for “Denosumab Ascend”, biosimilar to Amgen’s Xgeva® (denosumab).  In November 2025, Alkem’s subsidiary, Enzene, received a CHMP positive opinion for Osqay®, biosimilar to Amgen’s Prolia® (denosumab).  Enzene and Theramex entered into an agreement in 2021 under which Enzene will supply Theramex with its denosumab biosimilar for commercialisation in Europe, the UK, Switzerland and Australia.  Alkem and Ascend are currently parties to BPCIA litigation commenced by Amgen in November 2025 following the filing of Alkem/Ascend’s BLA for biosimilar denosumab in the US.

The second biosimilar to be recommended by CHMP at its June 2026 meeting was Qilu Pharma’s Nylaspeg™, biosimilar to Amgen’s Neulasta® (pegfilgrastim).  The recommendation comes over 7 years after the approval of the first European pegfilgrastim biosimilar, Accord Healthcare’s Pelgraz®, in September 2018.

CHMP’s June 2026 positive opinions for extended indications include:

  • Janssen’s Stelara® (ustekinumab) for the treatment of moderately to severely active ulcerative colitis in paediatric patients from the age of 2 years and older, who have had an inadequate response to, or were intolerant to either conventional therapy or a biologic.
  • AstraZeneca/Daiichi Sankyo’s Datroway® (datopotamab deruxtecan) as a monotherapy, for the first-line treatment of adult patients with unresectable or metastatic triple-negative breast cancer (TNBC) who are not candidates for PD-1/PD-L1 inhibitor therapy; and
  • Janssen’s Tecvayli® (teclistamab) in combination with daratumumab for the treatment of adult patients with relapsed or refractory multiple myeloma who have received at least one prior therapy.

New Indication Alert: MSD’s Pembrolizumab Approved for New Indications & Combinations in US & EU

On 25 June 2026, MSD announced that the FDA has approved each of Keytruda® (pembrolizumab) and Keytruda Qlex™ (pembrolizumab and berahyaluronidase alfa-pmph), in combination with Gilead’s Trodelvy® (sacituzumab govitecan-hziy) for the first-line treatment of adults with unresectable locally advanced or metastatic triple-negative breast cancer (TNBC) whose tumours express PD-L1 (Combined Positive Score [CPS] ≥10) as determined by an FDA-authorised test.  According to the announcement, these approvals represent the first regimen of a PD-1 inhibitor plus Trop-2 directed antibody-drug conjugate (ADC) in advanced TNBC.

The US approvals came a day after it was announced that Keytruda® was approved in Europe, in combination with Astellas’ Padcev™ (enfortumab vedotin), as neoadjuvant treatment (before surgery) and then continued after radical cystectomy (surgery) as adjuvant treatment, for adults with resectable muscle-invasive bladder cancer (MIBC) who are ineligible for cisplatin-containing chemotherapy in the EU.

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 appears to be the front runner, having demonstrated pharmacokinetic bioequivalence with Keytruda® in its “Dahlia” study (reported in February 2026).  Formycon’s US commercialisation partner, Zydus, has 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 Samsung Bioepis, Amgen, mAbxience, Sandoz, Celltrion, 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.

4 Pearce IP Patent Professionals Honoured In Managing IP’S IP STARS 2026

4 of Pearce IP’s patent professionals have been recognised in Managing IP’s IP STARS 2026, one of the world’s leading guides to IP firms and practitioners.

This year’s individual recognitions include:

These individual accolades follow the firm’s 2026 IP Stars rankings for Patent Disputes, Patent Prosecution, and Trade Mark Prosecution.

Naomi Pearce, Founder and CEO, says;

“These rankings are a testament not only to the calibre of our professionals and leaders, but also to the collaborative culture and high standards that define Pearce IP.  I am honoured to work alongside such dedicated practitioners and congratulate them on this achievement.”

We extend our sincere thanks to our clients, colleagues and peers for their continued trust and support.  Congratulations to Naomi, Helen, Jacinta, and Paul on this well-deserved recognition.


 

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.

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 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.

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.

 

MIP IP STARS 2026 Ranks Pearce IP for Patent Litigation, Patent Prosecution and Trade Mark Prosecution in Australia and New Zealand

Pearce IP has been ranked by Managing IP in the 2026 Asia-Pacific IP Stars for Patent Prosecution, Patent Disputes and Trade Mark Prosecution, marking the sixth consecutive year of rankings for the Australian office and the first for Pearce IP New Zealand which was founded in 2024.

In Australia, Pearce IP is ranked by MIP in 2026 for
Patent Prosecution,
Patent Disputes, and
Trade Mark – Patent & Trade Mark Attorney Firms.

In New Zealand, Pearce IP is ranked by MIP in 2026 for
Trade Mark Prosecution.

In addition, 4 of Pearce IP’s leaders and team members have been ranked among the leading IP practitioners in ANZ.

MIP IP STARS is recognised as a leading benchmark of excellence in the global IP profession.

Deputy CEO & Head of People & Culture at Pearce IP, Peter O’Sullivan, who joined Pearce IP in May says;

“What has impressed me most since joining Pearce IP is the calibre of our people and the genuine commitment across the firm to delivering exceptional client outcomes. These rankings reflect a culture built on collaboration, accountability and continuous improvement.

 

To see that recognised across multiple practice areas and jurisdictions is a significant achievement and speaks to the strength of the team and the foundation that has been built under Naomi’s leadership.”

Pearce IP Founder and CEO, Naomi Pearce, said the rankings recognise the firm’s continued focus on delivering exceptional outcomes for clients, across APAC;

“We are unapologetic in delivering to our 2027 Vision to be the premier life sciences IP/legal firm in Australia and New Zealand, and remain focused on providing world-class service and outstanding results for our clients.

 

Thank you to our clients for your ongoing support, and congratulations to every member of the Pearce IP team on this achievement.”


 

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.

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 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.

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.

 

Pearce IP BioBlast® for the week ending 19 June 2026

Pearce IP provides weekly reports on global biosimilars activities in the Pearce IP BioBlast®. Significant biosimilar activities for the week ending 19 June 2026 are set out below:


Aflibercept

On 19 June 2026, The Asia Business Daily reported that Alteogen Biologics’ MENA region partner, SPIMACO, has received product approval for ALT-L9 (aflibercept), biosimilar to… Read more here.

Bevacizumab

On 16 June 2026, Outlook Therapeutics announced that its resubmitted Biologics License Application (BLA) for ONS-5010/Lytenava™ (bevacizumab-vikg) has been accepted for… Read more here.

Dupilumab

On 18 June 2026, Korea Biomed reported that South Korean-headquartered Alteogen has disclosed in an investor communication that a non-exclusive licence agreement it… Read more here.

Secukinumab

On 18 June 2026, CSPC Pharmaceutical Group announced that China’s National Medical Products Administration (NMPA) has accepted its marketing authorisation application… Read more here.

Ustekinumab

On 18 June 2026, Samsung Bioepis and Organon announced the expansion of their development and commercialisation agreement for Canada to include Samsung Bioepis’… Read more here.

Biopharma News

On 17 June 2026, Sandoz announced the opening of its new biosimilar development centre in Ljubljana, Slovenia.  The construction of the fully digitally integrated USD 99 million… 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.

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 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.

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.

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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