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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.

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.

 

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 Attorney (AU, NZ) & Trade Mark Attorney (AU)

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.

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, Trade Mark Lawyer (AU) and Trade Mark Attorney (AU, NZ).

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.

 

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 Attorney (AU, NZ) & Trade Mark Attorney (AU)

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.

Organon & Shanghai Henlius Launch Denosumab Biosimilars in Canada

On 23 June 2026, Organon and Shanghai Henlius announced the Canadian launch of Bildyos® (denosumab injection, 60 mg/1 mL) and Tuzemty® (denosumab injection, 120 mg/1.7 mL), indicated for all approved reference indications of Amgen’s Prolia® and Xgeva®, respectively.

Bildyos® and Tuzemty® (HLX14) were approved in Canada in March 2026.  Organon was granted the exclusive commercialisation rights to Henlius’ denosumab biosimilars globally, “except for China; including Hong Kong, Macau and Taiwan”, under a June 2022 agreement.

Henlius/Organon have previously launched denosumab biosimilars in the US under the names Bildyos® and Bilprevda® (approved September 2025, launched October 2025).  Bildyos® and Bilprevda® were approved in the EU in September 2025.

Sandoz’s Wyost® (February 2024) and Jubbonti® (March 2024) were the first denosumab biosimilars approved in Canada, and were launched in August 2024.  This was followed by the Canadian approvals of Celltrion’s Stoboclo® and Osenvelt® (September 2025), Apotex’s Denoza™, biosimilar to Amgen’s Prolia®, (April 2026) and Biocon’s Bosaya™ and Vevzuo™ (April 2026).

AbbVie to Acquire US-Based Apogee Therapeutics in USD10.9B Deal

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 Therapeutics in an all-cash transaction valued at approximately USD$10.9 billion ($135.11 per share).

The transaction is expected to close in Q3/2026, subject to closing conditions including Apogee shareholder approval and receipt of regulatory approvals.

According to the companies, the acquisition of Apogee “holds potential for substantial shareholder value creation with mega-blockbuster peak sales potential across Apogee’s pipeline of assets”.

Apogee’s pipeline of assets includes zumilokibart (APG777) for the treatment of inflammatory diseases, including atopic dermatitis and asthma.  Zumilokibart is a subcutaneous antibody that is being positioned as a competitor to Eli Lilly’s Ebglyss® (lebrikizumab) and Regeneron/Sanofi’s Dupixent® (dupilumab).  In the Phase II clinical trial, zumilokibart demonstrated strong efficacy and a safety profile consistent with other medicines in its class.  Phase III trials are set to commence in 2026, with an anticipated commercial launch in 2029.

The acquisition of Apogee complements AbbVie’s current immunology portfolio, which includes Humira® (adalimumab), Skyrizi® (risankizumab) and Rinvoq® (upadacitinib) and generated $7.29 billion in the first quarter of 2026.

Janssen Commences BPCIA Litigation Against Alvotech for Biosimilar 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 and IV, infringe 14 Janssen patents relating to Simponi® (SC), Simponi Aria® (IV) and the manufacture and delivery of biologic products like golimumab.

The proceedings follow 2 weeks after Alvotech announced on 4 June 2026 that it had resubmitted its AVT05 BLA to the FDA.  Janssen alleges that by submitting its BLA for AVT05 SC and AVT05 IV and “taking concrete steps to market those products, Alvotech has infringed, and threatens to infringe, Janssen’s patents”.

Alvotech’s BLA for AVT05 was first accepted for review by the FDA in January 2025.  Alvotech received a Complete Response Letter from the FDA in November 2025 and subsequently undertook a “remediation project”.  The golimumab BLA was then resubmitted following completion of an FDA “routine cGMP surveillance inspection” of Alvotech’s Reykjavik manufacturing facility in May 2026 and the provision by Alvotech of responses to observations raised as a result of that inspection.  AVT05 will be commercialised in the US by Teva under an August 2020 strategic partnership.

The litigation against Alvotech is the second BPCIA proceeding regarding golimumab commenced by Janssen, following a complaint filed against Bio-Thera Solutions and Accord BioPharma in March 2026.  That complaint alleges that Bio-Thera/Accord’s golimumab biosimilars (Immgolis™ and Immgolis Intri™ (BAT2506)), the first and only golimumab biosimilars to have been FDA-approved (May 2026), infringe 17 Janssen patents.

AVT05 was the first golimumab biosimilar to be approved worldwide in September 2025, with its approval in Japan as Gobivaz®.  Gobivaz® received a positive CHMP opinion from the EMA in September 2025, followed by approval in Europe and the UK in November 2025, where it is commercialised by Advanz Pharma.

New Indication Alert: Chugai Secures New Indications in Japan for Rituximab and Bevacizumab

On 19 June 2026, Chugai Pharmaceutical (a Roche subsidiary) announced that the Japanese Ministry of Health, Labour and Welfare has approved Rituxan® (rituximab) for adult-onset frequently relapsing or steroid-dependent nephrotic syndrome, and Avastin® (bevacizumab) for treatment of neurofibromatosis type 2.  Avastin® is now the first drug approved in the world for the treatment of neurofibromatosis type 2.

Rituxan® was approved in Japan in August 2014 for paediatric-onset refractory nephrotic syndrome (frequently relapsing or steroid-dependent), in September 2024 for steroid-resistant paediatric-onset refractory nephrotic syndrome, and in March 2025 for paediatric-onset non-refractory frequently relapsing or steroid-dependent nephrotic syndrome.

Chugai currently co-promotes Rituxan® in Japan with Zenyaku Kogyo, which is the marketing authorisation holder.  However, in April 2026, Chugai and Zenyaku announced that they have terminated their co-promotion in Japan for Rituxan®, effective from 3 September 2026, at which time Zenyaku will assume sole responsibility for sales of Rituxan® in Japan.

Rituximab was one of the first mAbs to become “biosimilar”.  Both Pfizer and Sandoz/Kyowa Kirin market rituximab biosimilars in Japan.  Bevacizumab biosimilars have also been marketed in Japan for some time, including by Celltrion (Vegzelma™, launched January 2023) and Daiichi Sankyo/Amgen (bevacizumab BS for intravenous drip infusions, launched December 2019).

Alteogen’s Biosimilar Aflibercept Approved in Saudi Arabia

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 Regeneron/Bayer’s Eylea® (2 mg) from the Saudi Food and Drug Authority (SFDA).

The SFDA is a major regulatory agency in the Middle East and many MENA countries refer to SFDA approval results during their own regulatory review processes.  Alteogen therefore expects that the Saudi Arabian approval will expedite approval of ALT-L9 in other key MENA countries, including the United Arab Emirates, where regulatory review is underway.

ALT-L9 is the first biosimilar developed by Alteogen.  Alteogen entered into an exclusive agreement with SPIMACO in 2024 for the commercialisation rights to ALT-L9 in 16 MENA countries.

ALT-L9 was approved in Europe as Eyluxvi® in September 2025, following a positive CHMP opinion in July 2025.  In May 2026, Alteogen announced that the Korean Ministry of Food and Drug Safety had approved ALT-L9 as Eyzanfy™, 20 months after Alteogen had submitted its Korean marketing authorisation application in September 2024.

There are currently other established partnerships in relation to the commercialisation of aflibercept biosimilars in the MENA region.  This includes Formycon and MS Pharma, which partnered in May 2024 in relation to the commercialisation of Formycon’s FYB203 (aflibercept) in MENA, and Bioventure and Amman Pharmaceutical Industries, which entered into a licence agreement in 2023 under which Amman Pharma was granted exclusive rights to register and commercialise the Alvotech-developed aflibercept biosimilar in the Levant region.

Samsung Bioepis and Organon Expand Canadian Collaboration to Include Biosimilar Ustekinumab

On 18 June 2026, Samsung Bioepis and Organon announced the expansion of their development and commercialisation agreement for Canada to include Samsung Bioepis’ Pyzchiva® (SB17), biosimilar to J&J’s Stelara® (ustekinumab).  Current plans are for Pyzchiva® to be launched in Canada during 2026.

Under the terms of the expanded agreement, Organon will obtain the exclusive Canadian commercialisation rights to Pyzchiva®, while Samsung Bioepis retains full development, manufacturing, and regulatory responsibilities.

The new agreement expands the biosimilar portfolio under Samsung Bioepis and Organon’s collaboration in Canada (first established in 2013) from five to six biosimilars.  In addition to Pyzchiva®, the biosimilars encompassed by the agreement are Hadlima® (adalimumab; launched 50mg/mL in March 2021; 100mg/mL approved August 2022), Brenzys® (etanercept; approved September 2016), Renflexis® (infliximab; launched March 2018), Aybintio® (bevacizumab; launched November 2022), and Ontruzant® (trastuzumab; launched November 2022).

Samsung Bioepis had previously entered into an exclusive agreement with Sandoz in September 2023 for the development and commercialisation of SB17 in the US, Canada, EEA, Switzerland and the UK.  Sandoz launched Pyzchiva® in Europe in July 2024 and in the US in February 2025.

Pyzchiva® was approved in Canada in August 2024.  Other ustekinumab biosimilars approved and launched in Canada to date, include JAMP/Alvotech’s Jamteki® (approved November 2023, launched March 2024), Amgen’s Wezlana® (approved December 2023, launched March 2024), Celltrion’s Steqeyma® (approved July 2024, launched August 2024), Fresenius’ Otulfi® (approved January 2025, launched May 2025), Biocon’s Yesintek™ (approved October 2025, launched mid-October 2025) and Dong-A ST/Intas’ Imuldosa™ (approved January 2026, not yet launched).

CSPC Pharmaceutical’s Biosimilar Secukinumab MAA Accepted in China

On 18 June 2026, CSPC Pharmaceutical Group announced that China’s National Medical Products Administration (NMPA) has accepted its marketing authorisation application (MAA) for Secukinumab Injection, biosimilar to Novartis’ Cosentyx®.

Cosentyx® is approved in China for the treatment of plaque psoriasis in patients aged 6 years and older; and for psoriatic arthritis, ankylosing spondylitis, hidradenitis suppurativa and non-radiographic axial spondyloarthritis in adults.  According to the announcement, In phase 1 and 3 studies, CSPC’s biosimilar demonstrated high similarity to Cosentyx® in terms of efficacy, safety, pharmacokinetics, and immunogenicity.

This news follows Celltrion’s announcement earlier in June 2026 that it has filed an application for its secukinumab biosimilar (CT-P55) in Canada, seeking all approved reference indications.  Celltrion is planning additional regulatory filings for CT-P55 in the US, Europe and Korea.

Other secukinumab biosimilars are under development, including Bio-Thera’s BAT2306 (phase 1 trial completed in 2023, phase 3 clinical trial in plaque psoriasis completed in 2024, commercialisation agreement with Dr Reddy’s in November 2025), Taizhou Mabtech Pharmaceutical’s CMAB015 (phase 1 trial completed in 2023) and Livzon Pharmaceutical Group’s LZM012 (phase 3 clinical trial in plaque psoriasis commenced).

Sanofi & Alteogen Confirm Development of Subcutaneous 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 announced in November 2019 for its ALT-B4 technology with an “undisclosed” pharmaceutical company was a deal with Sanofi regarding development of a high-dose subcutaneous formulation of Dupixent® (dupilumab).  ALT-B4 is a recombinant human hyaluronidase enzyme platform (berahyaluronidase alfa) designed to convert intravenous (IV) drugs into subcutaneous formulations.

The Sanofi deal was said by Alteogen in 2019 to potentially be worth up to USD 1.37 billion.  It has been disclosed that Sanofi paid USD13 million upfront in December 2019 and made two subsequent milestone payments, one in March 2020 for an undisclosed amount and a second of USD3 million in April 2023.  No details about the clinical stage of the development have been announced.

Alteogen has since partnered with a number of companies for the use of ALT-B4 in the subcutaneous formulations.  In November 2024, Alteogen signed an exclusive US$300 million licence agreement with Daiichi Sankyo for the development and commercialisation of a subcutaneous injection form of Enhertu® (trastuzumab deruxtecan).  In January 2026, Alteogen entered an exclusive licence agreement with Tesaro, a GSK subsidiary, for the use of ALT-B4 in the development and commercialisation of a subcutaneous formulation of dostarlimab.

Alteogen collaborates with MSD on subcutaneous Keytruda® (pembrolizumab).  MSD’s subcutaneous pembrolizumab was approved in the US, as Keytruda Qlex™, in September 2025 across 38 indications and has also been approved in Europe (November 2025), Canada (February 2026) and Korea (May 2026).

In January 2023, Alteogen entered into an exclusive agreement with Sandoz for the use of ALT-B4 to develop a subcutaneous version of an undisclosed Sandoz biosimilar product, with an option for Sandoz to licence the Alteogen technology for two further products.

Sandoz Opens USD 99M Biosimilar Development Centre in Slovenia

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 facility was first announced in July 2025.

The centre will support end-to-end drug development and is fully integrated into the development network, including bioanalytical and bioassay laboratories in Holzkirchen, Germany and device development in Cambridge, UK.  The Slovenia biosimilar development centre is the first of three major investment projects in Slovenia, with Sandoz planning to invest a total of USD 1.1 billion across the three projects.

The new development centre joins Sandoz’s new facilities for drug production in Lendava, sterile production and packaging in Brnik and a biosimilar site acquired in Toulouse, France.  It follows Sandoz’s creation of a new global biosimilar development, manufacturing and supply unit, which came into effect on 1 April 2026.

According to Sandoz’s CEO, Richard Saynor, the new biosimilar development centre in Slovenia, together with Sandoz’s other manufacturing investments, will “help move biosimilars efficiently into production, supporting our ‘golden decade’ of more affordable healthcare, with approximately USD 320 billion in biologic patent expiries expected over the next decade”.

Pearce IP Appoints Peter O’Sullivan as Executive, Deputy CEO & Head of People and Culture

Pearce IP is pleased to announce the appointment of Peter O’Sullivan as Executive, Deputy CEO & Head of People and Culture.

Peter is an experienced C-suite professional services executive, and joins Pearce IP with more than 30 years’ experience spanning human resources, business, and law.  He holds an MBA, BA and LLB (Hons), is a Graduate Member of the Australian Institute of Company Directors (AICD), and has completed the Harvard Business School Global Executive Leadership Program.

Peter is Deputy CEO across ANZ and will oversee finance, operations, marketing, and human resources.  He will work closely with leadership and teams across the firm to support Pearce IP’s continued growth and strategic objectives.

Most recently, Peter spent 14 years at BDO, where, as Chief People Officer he played a significant role in people, culture, leadership, and organisational strategy during a period of substantial and sustained business growth.  His contribution as an executive leader at BDO was recognised with his appointment to the firm’s Partnership in 2024.

Peter began his career as a commercial litigator at major law firm Blake Dawson Waldron (now Ashurst), before transitioning into senior human resources and executive leadership roles.  His career has included senior human resources roles at Blake Dawson Waldron, the Queensland Department of Emergency Services, SPARQ Solutions, and Bankwest, and non-executive director roles with the Queensland Doctors’ Health Programme and Metro Arts.

Founder and CEO Naomi Pearce said the appointment reflects the next stage of Pearce IP’s evolution.

“Peter is a seasoned leader with qualifications and more than 30 years’ experience in HR, law and business, and I am delighted that he has joined Pearce IP.  As we approach delivery against our 2027 Vision, I am excited to work with Peter as we continue to set the standard for excellence in the provision of legal and IP services.”

Peter said:

“I’m delighted to be joining Pearce IP at such an exciting stage in its journey.  The firm has built a strong culture and reputation, and I look forward to working with Naomi and the team to support continued growth and deliver on Pearce IP’s long-term vision.  I believe great businesses are built on great people, and I’m excited to help strengthen the leadership, culture and operational capability that will underpin the next chapter.”

Peter’s appointment forms part of Pearce IP’s leadership investment as the firm continues delivering against its 2027 Vision and begins shaping its 2037 Vision.


 

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.

 

Outlook Therapeutics’ Resubmitted Ophthalmic Bevacizumab BLA Accepted for Review by FDA

On 16 June 2026, Outlook Therapeutics announced that its resubmitted Biologics License Application (BLA) for ONS-5010/Lytenava™ (bevacizumab-vikg) has been accepted for review by the FDA.  The Prescription Drug User Fee Act (PDUFA) target date is 29 July 2026.

If approved, ONS-5010/Lytenava™ will be the first ophthalmic formulation of bevacizumab-vikg approved by the FDA to treat wet AMD.  Outlook Therapeutics has commenced pre-launch activities in anticipation of the pending approval.

Since its initial BLA submission for ONS-5010/Lytenava™ in 2022, the FDA has issued three Complete Response Letters (CRL) to Outlook (in August 2023, August 2025 and December 2025).  After a Type A meeting in March 2026, Outlook requested a Formal Dispute Resolution (FDR) process.  In May 2026, the FDA granted the appeal, concluding that substantial evidence of effectiveness had been established for Lytenava™ for the treatment of wet AMD, despite the third CRL to the contrary.

Lytenava™ was approved in the EU in May 2024 and in the UK in July 2024.  It was launched in the UK and Germany in June 2025.

Intas Pharmaceuticals reportedly has an ophthalmic bevacizumab biosimilar under development, having received approval from India’s CDSCO in March 2025 to conduct Phase 2/3 trials of bevacizumab (solution for intravitreal injection 25mg/mL) in patients with wet AMD.

Pearce IP BioBlast® for the week ending 12 June 2026

Pearce IP provides weekly reports on global biosimilars activities in the Pearce IP BioBlast®. Significant biosimilar activities for the week ending 12 June 2026 are set out below:


Aflibercept

On 12 June 2026, Amgen provided an update in relation to its phase 3 clinical trial for ABP 938 8 mg, biosimilar to Regeneron/Bayer’s Eylea HD® (aflibercept, 8 mg)… Read more here.

Daratumumab

On 11 June 2026, Xbrane Biopharma and JOINN Biologics US announced that they have entered into a strategic partnership to develop Xbrane’s Xdarzane™, biosimilar… Read more here.

Denosumab

On 10 June 2026, GlycoNex announced that its denosumab biosimilar, SPD8, met the primary endpoint in a Phase 3 osteoporosis study conducted in Japan, demonstrating… Read more here.

 

On 9 June 2026, Mabpharm announced that China’s National Medical Products Administration (NMPA) has approved CMAB807 (Puboli®) (60 mg pre-filled syringe)… Read more here.

Nivolumab

On 11 June 2026, Ono Pharma announced that it submitted a supplemental application for Opdivo® Intravenous Infusion (nivolumab) in Japan, to expand its use for the… Read more here.

Pembrolizumab

On 12 June 2026, the FDA announced that it approved MSD’s Keytruda® (pembrolizumab) or Keytruda Qlex™ (pembrolizumab and berahyaluronidase alfa-pmph) in… Read more here.

Semaglutide

On 10 June 2026, Gedeon Richter and Indian-headquartered Hetero Labs announced that they have entered a global collaboration agreement to jointly develop, register… Read more here.

Serplulimub

On 9 June 2026, Shanghai Henlius Biotech announced that China’s National Medical Products Administration has approved a new indication of Hansizhuang® (serplulimab… Read more here.

Tocilizumab

On 10 June 2026, Organon announced that the FDA has approved its supplemental Biologics License Application (sBLA) for Tofidence® (IV), biosimilar to Genentech’s… Read more here.

Trastuzumab emtansine

On 10 June 2026, GxP News reported that Biocad has commenced patient enrolment for a phase 3 clinical trial of BCD-237 (trastuzumab emtansine), biosimilar to Genentech’s… 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 Attorney (AU, NZ) & Trade Mark Attorney (AU)

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 Launches Bevacizumab & Rituximab Biosimilars in Vietnam

On 15 June 2026, Celltrion announced that it has launched its rituximab and bevacizumab biosimilars in Vietnam.  Truxima®, biosimilar to Roche/Genentech/Biogen’s Rituxan®/MabThera® (rituximab), and Vegzelma™, biosimilar to Roche/Genentech’s Avastin® (bevacizumab) were launched by Celltrion on 9 June 2026, following receipt of marketing authorisation three months earlier.

Celltrion now has four biosimilars on the market in Vietnam, having previously launched Remsima® (infliximab) and Herzuma® (trastuzumab) in August 2025.  Celltrion plans to leverage marketing synergies between the four products to accelerate prescriptions and is planning to introduce follow-up products into the Vietnamese market, including Remsima® SC.

Rituximab was one of the first mAbs to become “biosimilar”, being first approved in the US on 26 November 1997.  There are three rituximab biosimilars currently on the US market: Teva and Celltrion’s Truxima® (launched in May 2020), Pfizer’s Ruxience® (launched in January 2020) and Amgen and Allergan’s RiabniTM (approved by the FDA in December 2020).

The first bevacizumab biosimilar approved in the US was Amgen’s Mvasi® in September 2017, with Mvasi® also being approved in Europe in January 2018.  There are currently five other bevacizumab biosimilars approved in the US: Pfizer’s Zirabev® (June 2019), Amneal’s Alymsys® (April 2022), Celltrion’s Vegzelma™ (September 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 (BLA) for its bevacizumab biosimilar, HLX04, was accepted for review by the FDA.

FDA Approves MSD’s Pembrolizumab/ Belzutifan Combo for Kidney Cancer

On 12 June 2026, the FDA announced that it approved MSD’s Keytruda® (pembrolizumab) or Keytruda Qlex™ (pembrolizumab and berahyaluronidase alfa-pmph) in combination with MSD’s Welireg® (belzutifan) for the adjuvant treatment of adults with renal cell carcinoma with a clear cell component at intermediate high or high risk of recurrence following nephrectomy, or following nephrectomy and resection of metastatic lesions.

The FDA reviewed the combination under Project Orbis, an initiative of the FDA’s Oncology Center of Excellence that provides a framework for the collaborative review of new cancer treatments among international regulatory partners.  For this review, FDA collaborated with the Australian Therapeutic Goods Administration (TGA) and Health Canada.  The application reviews are ongoing at the other regulatory agencies.

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.

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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