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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 26 September 2025

Pearce IP provides weekly reports on global biosimilars activities in the Pearce IP BioBlast®.  Significant biosimilar activities for the week ending 26 September 2025 are set out below:


Adalimumab

22 September 2025 | AU | Amgen’s High-Concentration Adalimumab Biosimilar AU Approved

On 22 September 2025, Australia’s Therapeutic Goods Administration approved Amgen’s high-concentration Amgevita® (100mg/ml), biosimilar to AbbVie’s Humira® (adalimumab), in the following… Read more here.


Aflibercept

25 September 2025 | DE | German Court Grants Cross-Border PI Preventing Launch of Formycon’s Biosimilar Aflibercept

On 25 September 2025, the Munich Regional Court granted Regeneron and Bayer a cross-border preliminary injunction (PI) preventing Formycon from launching FYB203, biosimilar to Regeneron/Bayer’s Eylea®… Read more here.

24 September 2025 | AU | Celltrion’s Application for Biosimilar Aflibercept Indication Extension Under Review in Australia

On 24 September 2025, Australia’s Therapeutic Goods Administration (TGA) updated its online list of prescription medicines for evaluation for the months of July, August and September… Read more here.

23 September 2025 | JP | KR | Sam Chun Dang’s Biosimilar Aflibercept Approved in Japan and Korea

On 23 September 2025, Korea Biomedical Review reported that Sam Chun Dang’s SCD411, biosimilar to Regeneron/Bayer’s Eylea® (aflibercept) was approved in both Japan and Korea… Read more here.


Bevacizumab, Ocrelizumab, Pertuzumab & More

24 September 2025 | NZ | New Zealand’s Pharmac Proposing to Fund Multiple Roche Biologics

New Zealand’s drug funding agency, Pharmac, has opened for public consultation a provisional agreement with Roche to fund a package of Roche drugs, including subcutaneous formulations… Read more here.


Canakinumab

23 September 2025 | RU | First Canakinumab Biosimilar Approved in Russia

On 23 September 2025, GxP News reported that Russian company, Generium, has obtained registration of the first Russian biosimilar to Novartis’ Ilaris® (canakinumab)… Read more here.


Guselkumab

19 September 2025 | US | New Indication Alert: FDA Approves J&J’s Subcutaneous Guselkumab for UC

On 19 September 2025, Johnson & Johnson announced that the FDA has approved a subcutaneous (SC) induction regimen of Tremfya® (guselkumab) for the treatment of adults with moderately to severely active ulcerative colitis (UC) … Read more here.


Nivolumab 

23 September 2025 | CA | Subcutaneous Nivolumab Recommended for Reimbursement in Canada for Solid Tumour Indications

On 23 September 2025, Bristol Myers Squibb announced that the Institut national d’excellence en santé et en services sociaux (INESSS) has issued a positive recommendation for the reimbursement of Opdivo® SC… Read more here.


Omalizumab

26 September 2025 | US | Amneal Submits US BLA for Omalizumab Biosimilar

On 26 September 2025, Amneal Pharmaceuticals announced that it submitted a Biologics License Application (BLA) to the US FDA for ADL-018 (omalizumab), biosimilar to Novartis’ Xolair®… Read more here.


Pembrolizumab

26 September 2025 | CN | Shanghai Henlius Kicks Off Pembrolizumab Biosimilar Trials in China

On 26 September 2025, Shanghai Henlius announced that the first patient has been dosed in its phase 1 multicentre clinical trial for HLX17, biosimilar to MSD’s Keytruda® (pembrolizumab)… Read more here.

24 September 2025 | IN | Intas Required to Revise Biosimilar Pembrolizumab Trial Protocol in India

On 24 September 2025, Medical Dialogues reported that India’s Subject Expert Committee (SEC) of the Central Drugs Standard Control Organisation (CDSCO) has instructed Intas Pharmaceuticals to submit a revised protocol… Read more here.


Pertuzumab

22 September 2025 | IN | Enzene’s Pertuzumab Biosimilar Launched in India

On 22 September 2025, Enzene Biosciences announced the Indian launch of its biosimilar to Roche’s Perjeta® (pertuzumab).  According to Enzene, the biosimilar is being marketed in India by… Read more here.


 

 

About Pearce IP

Pearce IP is a specialist firm offering intellectual property specialist lawyers and attorneys with a focus on the life sciences industries.  Pearce IP and its leaders are ranked in every notable legal directory for legal, patent and trade mark excellence, including: Chambers & Partners, Legal 500, IAM Patent 1000, IAM Strategy 300, MIP IP Stars, Doyles Guide, WTR 1000, Best Lawyers, WIPR Leaders, 5 Star IP Lawyers, among others.

In 2025, Pearce IP was recognised by Australasian Lawyer and New Zealand Lawyer’s 5 Star Employer of Choice, and is the “Standout Winner” for inclusion and culture for firms with less than 100 employees. Pearce IP was awarded “IP Team of the Year” by Lawyers Weekly at the 2021 Australian Law Awards. Pearce IP is recognised by Managing IP as the only leading ANZ IP firm 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 founder of Pearce IP, and is one of Australia’s leading IP practitioners.   Naomi is a market leading, strategic, commercially astute, patent lawyer, patent attorney and trade mark attorney, with over 25 years’ experience, and a background in molecular biology/biochemistry.  Ranked in virtually every notable legal directory, highly regarded by peers and clients, with a background in molecular biology, Naomi is renown for her successful and elegant IP/legal strategies.

Among other awards, Naomi is ranked in Chambers, IAM Patent 1000, IAM Strategy 300, is a MIP “Patent Star”, and is recognised as a WIPR Leader for patents and trade marks. Naomi is the 2023 Lawyers Weekly “IP Partner of the Year”, the 2022 Lexology client choice award recipient for Life Sciences, the 2022 Asia Pacific Women in Business Law “Patent Lawyer of the Year” and the 2021 Lawyers Weekly Women in Law SME “Partner of the Year”.  Naomi is the founder of Pearce IP, which commenced in 2017 and won 2021 “IP Team of the Year” at the Australian Law Awards.

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 and now at Pearce IP.

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.

Nathan Kan

Nathan Kan

Lawyer

Nathan is a lawyer specialising in life sciences, providing legal advice and litigation support across intellectual property and commercial disputes. He is passionate about the intersection of law and science, and during his time with the Science and Technology Law Association at the University of Melbourne, he helped lead events, workshops and publications across STEM fields including life sciences, AI and digital transformation.

US Reimbursement Boost for Fresenius’ Biosimilar Denosumab

On 29 September 2025, Fresenius Kabi announced that the US Centers for Medicare and Medicaid Services (CMS) assigned a permanent billing code for Conexxence® and Bomyntra®, biosimilars to Regeneron/Bayer’s Prolia® and Xgeva® (denosumab), respectively.  This will provide a streamlined reimbursement procedure for the products, effective 1 October 2025.

Conexxence® and Bomyntra® were FDA approved in March 2025 and launched in the US on 1 July 2025.

Fresenius Kabi entered a global settlement with Amgen in respect of its denosumab biosimilars in March 2025.  The settlement resulted in the dismissal of all claims and counterclaims in US BPCIA litigation commenced by Amgen against Fresenius in October 2024.  The global settlement permits European launch of Fresenius’ biosimilars at the end of November 2025.  Conexxence® and Bomyntra® were approved in Europe in July 2025.

Richter/Hikma’s Biosimilar Denosumab Seventh Approved in US

On 29 September 2025, Gedeon Richter and Hikma Pharmaceuticals announced they have secured FDA approval for Enoby™ (RGP-14-P) and Xtrenbo™ (RGP-14-P) (denosumab-qbde), biosimilars to Amgen’s Prolia® and Xgeva® (denosumab), respectively.

Hikma and Richter entered into a licence and commercialisation agreement for RGB-14 in December 2021.  Under the terms of the agreement, Richter is responsible for the development and manufacture of RGB-14, and Hikma is responsible for FDA registration and has exclusive rights to commercialise it in the US.

Richter/Hikma’s denosumab biosimilars are the seventh pair to be approved in the US, following Sandoz’s Jubbonti® and Wyost® (approved March 2024launched June 2025), Samsung Bioepis’ Obodence™ and Xbryk™ (approved February 2025, not yet launched), Celltrion’s Stoboclo® and Osenvelt® (approved March 2025launched July 2025), Fresenius Kabi’s Conexxence® and Bomyntra® (approved March 2025launched July 2025), Shanghai Henlius/Organon’s Bildyos® and Bilprevda® (approved September 2025, not yet launched) and Biocon’s Bosaya™ and Aukelso™ (approved September 2025, not yet launched).

On 25 June 2025, Amgen filed BPCIA litigation in the US District Court for the District of New Jersey against Hikma and Richter, asserting infringement of 32 patents covering denosumab, pharmaceutical compositions of denosumab, methods of manufacturing therapeutic proteins, like denosumab, and denosumab products.  The litigation followed the FDA’s acceptance in December 2024 of Richter/Hikma’s BLA for RGB-14-P and RGB-14-X.  Although Amgen has settled five of its denosumab BPCIA proceedings against other biosimilar manufacturers, the Richter/Hikma proceedings currently remain pending.

Outlook Therapeutics to Resubmit Ophthalmic Bevacizumab BLA to FDA Before End 2025

On 29 September 2025, Outlook Therapeutics announced that it has completed a Type A Meeting with the FDA to discuss the August 2025 complete response letter (CRL) declining Outlook’s BLA resubmission for its ophthalmic formulation of bevacizumab, ONS-5010/Lytenava™, for wet AMD.  Following “a productive discussion with the FDA”, Outlook “expects to resubmit its BLA before the end of calendar year 2025”.

Outlook has already resubmitted its BLA to the FDA once, in February 2025, following receipt of a first CRL from the FDA for ONS-5010 and its submission of a Special Protocol Assessment request in 2023 regarding further clinical trials.  A second CRL (August 2025) recommended Outlook submit additional efficacy data to support its application for ONS-5010.

Lytenava™ received marketing authorisation in the EU in May 2024 and was launched in the UK and Germany for wet AMD in June 2025.  The Scottish Medicines Consortium also accepted Lytenava™ for use within NHS Scotland 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.

Genmab to Acquire Merus in USD 8B Deal

On 29 September 2025, Genmab A/S and Merus N.V. announced that they have entered into an agreement for Genmab to acquire all the shares of Merus in an all-cash transaction worth approximately USD 8 billion, with the deal anticipated to close early in the first quarter of 2026.

The deal will expand Genmab’s biologics portfolio to include Merus’ petosemtamab (MCLA-158), which is currently in Phase 3 development and has been granted two Breakthrough Therapy Designations by the FDA for recurrent or metastatic programmed death-ligand 1 (PD-L1) positive head and neck squamous cell carcinoma indications.

Novartis to Launch US Direct Sales Platform for Secukinumab

On 29 September 2025, Novartis announced that it plans to launch a US direct-to-patient (DTP) platform for Cosentyx® (secukinumab) from 1 November 2025, offering cash-paying patients access to the drug at 55% off the list price.

According to Novartis, Cosentyx® is its top selling product in the US, and the DTP platform will offer the biologic to American patients “at a price that reflects the average savings that insurers and pharmacy benefit managers receive”.

There are a number of secukinumab biosimilars currently under development, including by Celltrion (phase 1 clinical trial completed; global phase 3 trial for CT-P55 in plaque psoriasis approved by the FDA in August 2024), Bio-Thera (phase 3 clinical trial of BAT2306 in plaque psoriasis completed in 2024, and phase 1 trial completed in 2023), Taizhou Mabtech Pharmaceutical (phase 1 trial of CMAB015 completed in 2023) and Livzon Pharmaceutical Group (phase 3 clinical trial of LZM012 in plaque psoriasis currently recruiting).

New Indication Alert: FDA Extends J&J’s Guselkumab to PsO and PsA in Children

On 29 September 2025, Johnson & Johnson announced that the US FDA has approved an indication extension for Tremfya® (guselkumab) for the treatment of severe plaque psoriasis (PsO) and active psoriatic arthritis (PsA) in children aged six and older, weighing at least 40 kg.  J&J submitted the two supplemental Biologics Licence Applications (sBLAs) for these indications in December 2024.

Tremfya® was first approved in the US for PsO (in adults) in July 2017.  Earlier in September 2025, the FDA approved a subcutaneous induction regimen of Tremfya® for the treatment of adults with moderately to severely active ulcerative colitis (UC).  This followed the approval of an intravenous (IV) induction regimen for UC in September 2024.

Biosimilar development of guselkumab is underway.  In September 2025, Polpharma and MS Pharma announced that they entered into a licensing agreement for the commercialisation of PB019, biosimilar guselkumab, in the MENA region.  In 2023, Alvotech and Advanz Pharma entered into a partnership agreement to commercialise a proposed guselkumab biosimilar in the EU, UK and Switzerland.

Here, There Be Trade Mark Dragons…or Double-headed Eagles

It’s not often that the Australian Registrar of Trade Marks looks at disclaimers (which were a thing before the Trade Marks Act 1995 (Cth) came into force), but Hunchy Hills Distillery Pty Ltd [2025] ATMO 180 delivered by Hearing Officer Nicole Worth on 5 September 2025 is one such case.

Spoiler alert: in Australia, disclaimers entered against trade marks generally have no impact on the assessment of deceptive similarity during the examination or opposition stages of the registration process, and this case is no exception.

Disclaimers were previously used under the 1955 Act to identify non-distinctive elements in a trade mark and to indicate to the public the scope of the exclusive rights afforded by a trade mark registration.  Under the 1995 Act, disclaimers are voluntary and – consequently – are rarely used.

The Hunchy Hills case is a short and sweet decision that helps us understand how disclaimers impact the assessment of deceptive similarity under section 44.

Hunchy Hills is a family-owned distillery based in the Sunshine Coast, Queensland.  It produces various types of gins (incidentally, they look fantastic) and sought registration of the Hunchy Hills’ Mark shown in the table below for a range of alcoholic and non-alcoholic beverages, as well as retail services, distillation services, entertainment and cultural services, and for food, drink and accommodation services.

The Earlier Marks were cited as barriers to acceptance of Hunchy Hills’ Mark during examination because the marks in the table each covered goods in Class 32 or 33 and each mark contained a double-headed eagle device.  During the examination process, which lasted across six (!) adverse reports, the Applicant provided evidence that two-headed eagle devices are commonly used in the beverages industry in numerous countries throughout the world and argued that the disclaimers against the Earlier Marks constituted “other circumstances” that would make it proper for the Applicant’s mark to be accepted for registration (s44(3)(b)).  The Examiner declined to accept this position so Hunchy Hills sought a hearing before a delegate of the Registrar.

The Hearing Officer found that Hunchy Hills’ Mark was deceptively similar to each of the Earlier Marks, despite the evidence showing the common nature of the double-headed eagle device for alcoholic and non-alcoholic beverages.  In relation to the disclaimers applied to each of the Earlier Marks, the Hearing Officer held that disclaimers are not to be used to permit the registration of a trade mark that would otherwise not be registrable, regardless of whether they were entered under the 1955 Act or the 1995 Act (citing Lee J in Bausch & Lomb Inc. v Registrar of Trade Marks (1980) 42 FLR 459 at 549 and Davison M and Horak I, Shanahan’s Australia Law of Trade Marks and Passing Off (Law book Co., 7th ed, 2022), [45.515]).

The particular wording of the disclaimers meant that the registered owner of the Earlier Marks only has exclusive rights over double-headed eagles that are depicted in the same manner as shown in the Earlier Marks, but not over other depictions of double-headed eagles.  So, if a trade mark application covered a significantly different looking double-headed eagle, the Earlier Marks may not prevent the different-looking double-headed eagle device mark from achieving registration.  At [30], the Hearing Officer provided the following registered trade marks as examples to illustrate her point:

The takeaway point is…in Australia, disclaimers entered against trade marks generally have no impact on the assessment of deceptive similarity during the examination or opposition stages of the registration process.

 

About Pearce IP

Pearce IP is a specialist firm offering intellectual property specialist lawyers and attorneys with a focus on the life sciences industries.  Pearce IP and its leaders are ranked in every notable legal directory for legal, patent and trade mark excellence, including: Chambers & Partners, Legal 500, IAM Patent 1000, IAM Strategy 300, MIP IP Stars, Doyles Guide, WTR 1000, Best Lawyers, WIPR Leaders, 5 Star IP Lawyers, among others.

In 2025, Pearce IP was recognised by Australasian Lawyer and New Zealand Lawyer’s 5 Star Employer of Choice, and is the “Standout Winner” for inclusion and culture for firms with less than 100 employees. Pearce IP was awarded “IP Team of the Year” by Lawyers Weekly at the 2021 Australian Law Awards. Pearce IP is recognised by Managing IP as the only leading ANZ IP firm 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 founder of Pearce IP, and is one of Australia’s leading IP practitioners.   Naomi is a market leading, strategic, commercially astute, patent lawyer, patent attorney and trade mark attorney, with over 25 years’ experience, and a background in molecular biology/biochemistry.  Ranked in virtually every notable legal directory, highly regarded by peers and clients, with a background in molecular biology, Naomi is renown for her successful and elegant IP/legal strategies.

Among other awards, Naomi is ranked in Chambers, IAM Patent 1000, IAM Strategy 300, is a MIP “Patent Star”, and is recognised as a WIPR Leader for patents and trade marks. Naomi is the 2023 Lawyers Weekly “IP Partner of the Year”, the 2022 Lexology client choice award recipient for Life Sciences, the 2022 Asia Pacific Women in Business Law “Patent Lawyer of the Year” and the 2021 Lawyers Weekly Women in Law SME “Partner of the Year”.  Naomi is the founder of Pearce IP, which commenced in 2017 and won 2021 “IP Team of the Year” at the Australian Law Awards.

Kimberley Evans

Kimberley Evans

Executive, Lawyer (AU) & Trade Mark Attorney (AU), (Head of Trade Marks)

Kim is a lawyer and registered Trans-Tasman trade mark attorney with a wide-ranging and impressive practice background spanning private practice, in-house experience and academic activities. Kim’s clients appreciate her responsiveness, and her ability to provide clear and pragmatic branding advice that is tailored to their commercial objectives and informed by industry developments.

Shanghai Henlius Kicks Off Pembrolizumab Biosimilar Trials in China

On 26 September 2025, Shanghai Henlius announced that the first patient has been dosed in its phase 1 multicentre clinical trial for HLX17, biosimilar to MSD’s Keytruda® (pembrolizumab).

The trial is being conducted in China to evaluate the pharmacokinetic profile, efficacy, safety and immmunogencity of HLX17 in comparison to US-sourced Keytruda® in patients with multiple-resected solid tumours (including non-small cell lung cancer, melanoma, or renal cell carcinoma).

A number of pembrolizumab biosimilars are currently in clinical trials, including by Samsung Bioepis, Amgen, mAbxience, Sandoz, Formycon, Celltrion, Bio-Thera and BioNTech.  Alvotech and Dr Reddy’s have entered into a global collaboration and licence agreement to co-develop, manufacture and commercialise a biosimilar to Keytruda®.  Bioéticos claims to have launched the first pembrolizumab biosimilar in Paraguay in August 2025 under the name Pembrolizumab Bioéticos.

Amneal Submits US BLA for Omalizumab Biosimilar

On 26 September 2025, Amneal Pharmaceuticals announced that it submitted a Biologics License Application (BLA) to the US FDA for ADL-018 (omalizumab), biosimilar to Novartis’ Xolair®.

ADL-018 was developed by Kashiv Biosciences, with Amneal holding exclusive US commercialisation rights for the product under a July 2024 licensing agreement.

Kashiv has also entered into agreements for the commercialisation of ADL-018 in other regions, including with CRISTÁLIA for LATAM markets (August 2025), MS Pharma for MENA markets (August 2025) and Alvotech for the EU, UK, Australia, Canada and New Zealand (AVT23, October 2023).  A marketing application for AVT23 was accepted by the UK’s MHRA in March 2025.

Kashiv commenced Phase III trials of ADL-018 in October 2023 (patient enrolment completed in July 2024) in patients with chronic idiopathic/spontaneous urticaria following completion of Phase I trials in June 2023.

On 19 September 2025, Celltrion announced that it will begin the European launch of its biosimilar omalizumab, Omlyclo®, in Norway.  Omalizumab biosimilars are also being developed by Aurobindo, Teva and Glenmark.

German Court Grants Cross-Border PI Preventing Launch of Formycon’s Biosimilar Aflibercept

On 25 September 2025, the Munich Regional Court granted Regeneron and Bayer a cross-border preliminary injunction (PI) preventing Formycon from launching FYB203, biosimilar to Regeneron/Bayer’s Eylea® (aflibercept).  According to the Juve Patent report, the PI covers 22 European countries, including Germany and is based on a finding of infringement by equivalence of Regeneron’s formulation patent, EP 2 364 691.  The judgment is not yet available in English.

FYB203 received European marketing approval in January 2025 as Baiama® and Ahzantive® and UK approval in February 2025.  FYB203 was developed by Formycon, and Klinge holds the exclusive commercialisation rights.  In mid-January 2025, Formycon/Klinge and Teva Pharmaceuticals entered a collaboration agreement for the semi-exclusive commercialisation of FYB203 (as Ahzantive®) in Europe (excluding Italy) and Israel.  On 17 September 2025, Formycon announced that Klinge had entered a semi-exclusive licence agreement with Horus Pharma, for the commercialisation of FYB203 (under the brand name Baiama®) in selected European countries.

The dispute between Regeneron/Bayer and Formycon in relation to FYB203 is not limited to Germany, with legal proceedings in the US, UK, Italy, Belgium, the Netherlands, and France.  In the US, FYB203 is subject to a preliminary injunction granted in June 2024, resulting from a patent infringement proceeding brought by Regeneron in November 2023, which was upheld on appeal in January 2025.  In the UK, a hearing in the infringement action brought by Regeneron and Bayer against Formycon and Klinge’s FYB203 took place in the High Court (Patents Court) in June 2025.  The UK Court decision is pending.

Regeneron/Bayer Appeal Australian Court’s Refusal to Grant PI and Prevent Launch of Sandoz’s Biosimilar Aflibercept

Regeneron and Bayer have moved swiftly to appeal Justice Rofe’s decision denying Regeneron and Bayer’s application for PI on MOT patent AU2012205599 to restrain Sandoz from launching its biosimilar aflibercept (Afqlir® and Enzeevu®) in Australia.  Our report on her Honour’s decision can be found here.

On 17 September 2025, Regeneron filed an application for leave to appeal Justice Rofe’s decision.  There is no automatic right to appeal from an interlocutory decision of the Federal Court of Australia and Regeneron/Bayer must obtain leave before the Full Court will hear the appeal.  Often the leave application and, if leave is granted, the substantive appeal, are heard at the same time.

The Federal Court has listed the matter for hearing of both the leave application and the appeal on 29 October 2025 before Justices Beach, Burley and Moshinsky.

The case is of considerable interest, particularly given the number of biosimilar competitors, including Samsung Bioepis and Celltrion, that are lining up to enter the Australian aflibercept market.  Actor Pharmaceuticals, which does not yet have an aflibercept biosimilar approved in Australia, also filed revocation proceedings against Regeneron and Bayer in the Australian Federal Court on 5 August 2025, seeking to invalidate AU2012205599, with a first case management hearing in that matter currently scheduled for 8 October 2025.

 

About Pearce IP

Pearce IP is a specialist firm offering intellectual property specialist lawyers and attorneys with a focus on the life sciences industries.  Pearce IP and its leaders are ranked in every notable legal directory for legal, patent and trade mark excellence, including: Chambers & Partners, Legal 500, IAM Patent 1000, IAM Strategy 300, MIP IP Stars, Doyles Guide, WTR 1000, Best Lawyers, WIPR Leaders, 5 Star IP Lawyers, among others.

In 2025, Pearce IP was recognised by Australasian Lawyer and New Zealand Lawyer’s 5 Star Employer of Choice, and is the “Standout Winner” for inclusion and culture for firms with less than 100 employees. Pearce IP was awarded “IP Team of the Year” by Lawyers Weekly at the 2021 Australian Law Awards. Pearce IP is recognised by Managing IP as the only leading ANZ IP firm 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 founder of Pearce IP, and is one of Australia’s leading IP practitioners.   Naomi is a market leading, strategic, commercially astute, patent lawyer, patent attorney and trade mark attorney, with over 25 years’ experience, and a background in molecular biology/biochemistry.  Ranked in virtually every notable legal directory, highly regarded by peers and clients, with a background in molecular biology, Naomi is renown for her successful and elegant IP/legal strategies.

Among other awards, Naomi is ranked in Chambers, IAM Patent 1000, IAM Strategy 300, is a MIP “Patent Star”, and is recognised as a WIPR Leader for patents and trade marks. Naomi is the 2023 Lawyers Weekly “IP Partner of the Year”, the 2022 Lexology client choice award recipient for Life Sciences, the 2022 Asia Pacific Women in Business Law “Patent Lawyer of the Year” and the 2021 Lawyers Weekly Women in Law SME “Partner of the Year”.  Naomi is the founder of Pearce IP, which commenced in 2017 and won 2021 “IP Team of the Year” at the Australian Law Awards.

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.

Intas Required to Revise Biosimilar Pembrolizumab Trial Protocol in India

On 24 September 2025, Medical Dialogues reported that India’s Subject Expert Committee (SEC) of the Central Drugs Standard Control Organisation (CDSCO) has instructed Intas Pharmaceuticals to submit a revised protocol for its proposed biosimilar pembrolizumab Phase I/III clinical trial.

Intas’ proposed clinical trial is intended to be a multicentre study comparing the efficacy, safety, pharmacokinetics and immunogenicity of INTP58 with MSD’s Keytruda® (pembrolizumab), both administered with chemotherapy, in first line treatment of locally advanced or metastatic squamous or non-squamous non-small cell lung cancer.  The SEC raised a number of issues in relation to the trial protocol, including that the study duration should be increased, and the dose of chemotherapy (paclitaxel) should be reduced.

There are a number of pembrolizumab biosimilars already in clinical trials, including those of Samsung Bioepis, Amgen, mAbxience, Sandoz, Formycon, Celltrion, Shanghai Henlius, Bio-Thera and BioNTech.  Alvotech and Dr Reddy’s entered into a global collaboration and licence agreement to co-develop, manufacture and commercialise a biosimilar to Keytruda®Bioéticos claimed to have launched the first pembrolizumab biosimilar in Paraguay in August 2025, under the name Pembrolizumab Bioéticos.

New Zealand’s Pharmac Proposing to Fund Multiple Roche Biologics

New Zealand’s drug funding agency, Pharmac, has opened for public consultation a provisional agreement with Roche to fund a package of Roche drugs, including subcutaneous formulations of biologics previously only funded as IV treatments.  The agreement includes the following biologics:

  • Avastin® (bevacizumab) for ocular conditions only. This represents a rare example of Pharmac funding two suppliers’ brands of the same biologic.  Celltrion’s bevacizumab biosimilar, Vegzelma®, was awarded Principal Supply Status for all reference indications by Pharmac in February 2025.  However, the agreement with Celltrion specifically allowed other brands to be funded for ocular conditions only.
  • Ocrevus® SC (ocrelizumab), alongside IV Ocrevus®. Most patients are expected to switch to Ocrevus® SC.  No ocrelizumab biosimilars have been submitted for approval in New Zealand to date.
  • Phesgo® (pertuzumab and trastuzumab) for subcutaneous treatment of HER2-positive metastatic breast cancer. Roche’s Perjeta® (pertuzumab) and Celltrion’s Herzuma® (biosimilar trastuzumab) are already funded as separate IV infusions for people with HER2-positive metastatic breast cancer.  It is expected that most patients receiving these in combination will now receive Phesgo® as it can be administered faster than the IV infusions, providing the same treatment benefit with less time spent receiving treatment.
  • Vabysmo® (faricimab) for diabetic macular oedema and wet age-related macular degeneration. Funding criteria will be the same as updated criteria for aflibercept (Regeneron’s Eylea®).  Criteria for funding ranibizumab are also being updated.
  • Gazyva® (obinutuzumab) and MabThera® (rituximab) will have funding criteria updated. No MabThera® biosimilar is currently funded for rheumatoid arthritis to date due to Roche patent protection subsisting in New Zealand for that indication.  Sandoz’s biosimilar rituximab, Riximyo®, is funded for all other (off-patent) indications.

Submissions on the provisional agreement may be made until 5.00pm 8 October 2025 (NZ time).

Celltrion’s Application for Biosimilar Aflibercept Indication Extension Under Review in Australia

On 24 September 2025, Australia’s Therapeutic Goods Administration (TGA) updated its online list of prescription medicines for evaluation for the months of July, August and September.  Among the additions is Celltrion’s July 2025 application for an indication extension to Eydenzelt®, biosimilar to Regeneron’s Eylea® (aflibercept 2mg), for all reference indications.

Eydenzelt® was the first aflibercept biosimilar TGA-approved on 31 March 2025 (solely for myopic CNV).  It was followed by Sandoz’s Afqlir® and Enzeevu® on 27 May 2025, and Samsung Bioepis’ Opuviz® on 18 September 2025, which were each approved for all reference indications.  Sandoz’s products were the first aflibercept biosimilars to be considered and recommended for listing on Australia’s Pharmaceutical Benefits Scheme with listing anticipated on 1 December 2025.

Aflibercept is currently the subject of patent infringement and revocation proceedings in Australia against Sandoz, with Actor separately challenging Regeneron/Bayer aflibercept patents.  On 8 September 2025, the Federal Court of Australia published a judgment refusing to award Regeneron and Bayer an interlocutory injunction against Sandoz to prevent the launch of Sandoz’s Afqlir® in light of Regeneron 2032 expiring MOT patent AU2012205599.  Regeneron/Bayer filed an application for leave to appeal that decision on 17 September 2025, with the Full Court to hear the leave application on 29 October 2025.  Regeneron/Bayer are also separately seeking preliminary discovery from Sandoz in relation to a second Regeneron aflibercept 2040 expiring process patent AU2020397865, with a hearing scheduled in that matter on 6 November 2025.

Actor Pharmaceuticals, which does not yet have an aflibercept biosimilar approved in Australia filed revocation proceedings in the Australian Federal Court on 5 August 2025 seeking to invalidate Regeneron’s AU2012205599.  A first case management hearing in that matter is currently scheduled for 8 October 2025.

Pearce IP BioBlast® for the week ending 19 September 2025

Pearce IP provides weekly reports on global biosimilars activities in the Pearce IP BioBlast®.  Significant biosimilar activities for the week ending 19 September 2025 are set out below:


Aflibercept

21 September 2025 | IN | CA | Biocon’s Biosimilar Aflibercept Recommended in India; Publicly Funded in Canada

On 21 September 2025, Medical Dialogues reported that Biocon has received recommendations from India’s Subject Expert Committee (SEC) under the Central Drugs Standard Control Organisation… Read more here.

18 September 2025 | AU | Samsung Bioepis’ Aflibercept Biosimilar Third to be Approved in Australia

On 18 September 2025, Samsung Bioepis’ Opuviz®, biosimilar to Regeneron/Bayer’s Eylea® (aflibercept 2mg), was approved by Australia’s Therapeutic Goods Administration (TGA) in 2 presentations… Read more here.

17 September 2025 | AU | Regeneron/Bayer Appeal Australian Court’s Refusal to Grant PI and Prevent Launch of Sandoz’s Biosimilar Aflibercept

On 17 September 2025, Regeneron filed an application for leave to appeal the decision of Justice Rofe of the Federal Court of Australia refusing to award Regeneron/Bayer a preliminary injunction against Sandoz… Read more here.

17 September 2025 | US | Alvotech Files US PGR Challenging Regeneron’s Method of Treatment Patent for High Dose Aflibercept

On 17 September 2025, Alvotech filed a petition for post grant review of Regeneron’s patent… Read more here.

17 September 2025 | EU | Alteogen’s Biosimilar Aflibercept EU Approved

On 17 September 2025, Alteogen announced that the European Commission has approved Eyluxvi® (ALT-L9), biosimilar to Regeneron/Bayer’s Eylea® (aflibercept)… Read more here.

17 September 2025 | EU | Formycon/Klinge’s Biosimilar Aflibercept to be Commercialised by Horus Pharma in EU

On 17 September 2025, Formycon announced that Klinge Biopharma, the exclusive holder of the global commercialisation rights for Formycon’s FYB203, biosimilar to Regeneron/Bayer’s Eylea® (aflibercept)… Read more here.


Denosumab

19 September 2025 | EU | European Commission Approves Shanghai Henlius/Organon’s Denosumab Biosimilars

On 19 September 2025, Shanghai Henlius and Organon announced that the European Commission has approved Bildyos® and Bilprevda® (HLX14)… Read more here.

19 September 2025 | CuraTeQ Announces Positive Ph 3 Results for Biosimilar Denosumab

On 19 September 2025, Aurobindo Pharma subsidiary, CuraTeQ Biologics, announced positive results from its Phase 3 trial of BP16… Read more here.

18 September 2025 | CA | Celltrion’s Denosumab Biosimilars Second to be Approved in Canada

On 18 September 2025, Celltrion announced that Health Canada has granted approval for Stoboclo® and Osenvelt® (CT-P41), biosimilars to Amgen’s… Read more here.

17 September 2025 | US | FDA Approves Biocon’s Denosumab Biosimilars Bosaya™ and Aukelso™

On 17 September 2025, Biocon Biologics announced that it received FDA approval for denosumab products Bosaya™ and Aukelso™, biosimilars to Amgen’s… Read more here.


Golimumab, Denosumab, Ustekinumab

19 September 2025 | EU | Positive CHMP Opinions for 9 Biosimilars – Good News for Alvotech, Advanz, STADA, Dr Reddy’s, Teva, Intas & Bio-Thera

On 19 September 2025, the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) published the outcomes of its September meeting… Read more here.


Golimumab, Denosumab, Aflibercept

19 September 2025 | JP | Alvotech/Fuji Pharma’s JP Golimumab Biosimilar First Approved Worldwide; Aflibercept & Denosumab Biosimilars Also JP Approved

On 19 September 2025, Alvotech announced that Fuji Pharma, its commercialisation partner in Japan, has received approval from the Japanese Ministry of Health, Labour and Welfare for 3 biosimilars … Read more here.


Omalizumab 

19 September 2025 | NO | Celltrion Launches Biosimilar Omalizumab in Norway; Presents Ph 3 Results from Switching Study

On 19 September 2025, Celltrion announced that it will begin the European launch of Omlyclo®, biosimilar to Genentech’s Xolair® (omalizumab), in Norway… Read more here.


Pembrolizumab

19 September 2025 | US | EU | MSD’s Subcutaneous Keytruda® (Pembrolizumab) Approved in US & Recommended in EU

On 19 September 2025, MSD announced that Keytruda Qlex™ (pembrolizumab and berahyaluronidase alfa-pmph; MK-3475A) has been approved by the FDA for subcutaneous use in adults… Read more here.


Secukinumab

15 September 2025 | MENA | Bio-Thera & Jamjoom Pharma Partner on Secukinumab Biosimilar in MENA

On 15 September 2025, Bio-Thera and Saudi Arabia-headquartered Jamjoom Pharmaceuticals Factory Company announced they have entered a strategic commercialisation… Read more here.


Tocilizumab

22 September 2025 | JP | Celltrion’s Biosimilar Tocilizumab First to be Approved in Japan

On 22 September 2025, Celltrion announced that Japan’s Ministry of Health, Labor and Welfare has approved Avtozma®/CT-P47, biosimilar to Roche’s Actemra® … Read more here.


Ustekinumab

16 September 2025 | JP | Mitsubishi Tanabe’s Co-Promotion of Janssen’s Stelara® to End on 31 December 2025 in Japan

On 16 September 2025, First Word Pharma reported that Mitsubishi Tanabe Pharma Corporation’s (MTPC) contract with Janssen for co-promotion activities for Janssen’s Stelara®… Read more here.

10 September 2025 | NL | Dutch Court Validates Janssen’s Ustekinumab Patent for Treating UC

On 10 September 2025, the District Court of The Hague delivered judgment in Samsung Bioepis’ revocation action against Janssen’s EP 3 883 606 (the Janssen Patent)… Read more here.


 

 

About Pearce IP

Pearce IP is a specialist firm offering intellectual property specialist lawyers and attorneys with a focus on the life sciences industries.  Pearce IP and its leaders are ranked in every notable legal directory for legal, patent and trade mark excellence, including: Chambers & Partners, Legal 500, IAM Patent 1000, IAM Strategy 300, MIP IP Stars, Doyles Guide, WTR 1000, Best Lawyers, WIPR Leaders, 5 Star IP Lawyers, among others.

In 2025, Pearce IP was recognised by Australasian Lawyer and New Zealand Lawyer’s 5 Star Employer of Choice, and is the “Standout Winner” for inclusion and culture for firms with less than 100 employees. Pearce IP was awarded “IP Team of the Year” by Lawyers Weekly at the 2021 Australian Law Awards. Pearce IP is recognised by Managing IP as the only leading ANZ IP firm 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 founder of Pearce IP, and is one of Australia’s leading IP practitioners.   Naomi is a market leading, strategic, commercially astute, patent lawyer, patent attorney and trade mark attorney, with over 25 years’ experience, and a background in molecular biology/biochemistry.  Ranked in virtually every notable legal directory, highly regarded by peers and clients, with a background in molecular biology, Naomi is renown for her successful and elegant IP/legal strategies.

Among other awards, Naomi is ranked in Chambers, IAM Patent 1000, IAM Strategy 300, is a MIP “Patent Star”, and is recognised as a WIPR Leader for patents and trade marks. Naomi is the 2023 Lawyers Weekly “IP Partner of the Year”, the 2022 Lexology client choice award recipient for Life Sciences, the 2022 Asia Pacific Women in Business Law “Patent Lawyer of the Year” and the 2021 Lawyers Weekly Women in Law SME “Partner of the Year”.  Naomi is the founder of Pearce IP, which commenced in 2017 and won 2021 “IP Team of the Year” at the Australian Law Awards.

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 and now at Pearce IP.

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.

Nathan Kan

Nathan Kan

Lawyer

Nathan is a lawyer specialising in life sciences, providing legal advice and litigation support across intellectual property and commercial disputes. He is passionate about the intersection of law and science, and during his time with the Science and Technology Law Association at the University of Melbourne, he helped lead events, workshops and publications across STEM fields including life sciences, AI and digital transformation.

Subcutaneous Nivolumab Recommended for Reimbursement in Canada for Solid Tumour Indications

On 23 September 2025, Bristol Myers Squibb announced that the Institut national d’excellence en santé et en services sociaux (INESSS) has issued a positive recommendation for the reimbursement of Opdivo® SC (nivolumab for subcutaneous injection) in Quebec across Health Canada-authorised solid tumour indications where Opdivo® (nivolumab) for intravenous infusion is reimbursed.

Opdivo® SC was approved for solid tumour indications in Canada and the EU in May 2025, following similar approvals in the US (December 2024) and UK (April 2025).

At least Amgen, Sandoz and Xbrane/Intas have nivolumab biosimilars under development, and Zydus received regulatory approval for its nivolumab biosimilar from India’s CDSCO in July 2024.

First Canakinumab Biosimilar Approved in Russia

On 23 September 2025, GxP News reported that Russian company, Generium, has obtained registration of the first Russian biosimilar to Novartis’ Ilaris® (canakinumab).  The biosimilar, Limiris™, has been approved as a lyophilised powder for subcutaneous injection and is indicated for the treatment of Still’s disease, systemic juvenile idiopathic arthritis, autoinflammatory diseases, and gouty arthritis.

Generium offers a number of biosimilar products in Russia including Elizaria®, biosimilar to Alexion’s Soliris® (eculizumab) (approved April 2019) and Genolar®, biosimilar to Genentech’s Xolair® (omalizumab) (approved February 2022).

There have not been any reports of canakinumab biosimilars approved elsewhere.  However, in May 2025, Alvotech and Advanz expanded their partnership to include the development and commercialisation of a canakinumab biosimilar in Europe.

Sam Chun Dang’s Biosimilar Aflibercept Approved in Japan and Korea

On 23 September 2025, Korea Biomedical Review reported that Sam Chun Dang’s SCD411, biosimilar to Regeneron/Bayer’s Eylea® (aflibercept), was approved in both Japan and Korea in vial and pre-filled syringe (PFS) forms.

The latest approvals follow SCD411’s Canadian approval on 26 June 2025 and European approval in August 2025, also in vial and PFS forms.  At the time of the European approval, SCD considered it may be the first to launch a PFS aflibercept biosimilar in Europe, after being the first to do so in Canada.  SCD reportedly licensed SCD411 to Apotex for the Canadian market (August 2023), to an unnamed distributor for Austria, Germany, Italy, Spain and Switzerland (November 2023), and to a further unnamed distributor for the UK, Belgium, Netherlands, Norway, Portugal, Sweden, Greece, Ireland and Finland (March 2024).

In July 2025, the Seoul Central District Court refused Regeneron/Bayer’s request for an order that SCD submit various documents and information in connection with a lawsuit alleging that SCD’s licence agreement with an unnamed overseas company to supply SCD411 constituted infringement of Regeneron’s Korean Patent 659477.

Alvotech/Fuji Pharma received Japanese approval for biosimilar aflibercept (AVT06) earlier this month (September 2025).  In Korea Samsung Bioepis’ Afilivu® (SB15) (February 2024) and  Celltrion’s Eydenzelt® (CT-P42) (May 2024) have been approved.

Celltrion’s Biosimilar Tocilizumab First to be Approved in Japan

On 22 September 2025, Celltrion announced that Japan’s Ministry of Health, Labor and Welfare has approved Avtozma®/CT-P47, biosimilar to Roche’s Actemra® (tocilizumab), for the treatment of rheumatoid arthritis (RA), juvenile idiopathic arthritis (JIA), Castleman disease (CD), and cytokine release syndrome (CRS).

This marks the first tocilizumab biosimilar approved in Japan, with Celltrion planning to launch “quickly” to secure “first mover advantage”.

In May 2025, Avtozma® became the first approved tocilizumab biosimilar in Australia.  In February 2025, Avtozma® became the third tocilizumab biosimilar approved in the EU, following Fresenius Kabi’s Tyenne®, in both IV and SC forms, in November 2023, and Biogen’s IV Tofidence™, in June 2024.

Avtozma® was also the third tocilizumab biosimilar approved in the US in January 2025, trailing Fresenius Kabi’s Tyenne® (tocilizumab-aazg) (SC formulation, March 2024) and Biogen/Bio-Thera’s Tofidence®/BAT1806 (tocilizumab-bavi) (IV formulation, September 2023).

Enzene’s Pertuzumab Biosimilar Launched in India

On 22 September 2025, Enzene Biosciences announced the Indian launch of its biosimilar to Roche’s Perjeta® (pertuzumab).  According to Enzene, the biosimilar is being marketed in India by “multiple leading pharmaceutical companies”.  This includes Enzene’s parent company, Alkem Laboratories, which is marketing the biosimilar under the name Pertuza®, and Hetero Healthcare, which has announced the launch of the Enzene biosimilar under the name Perzea®.

Other pertuzumab biosimilars approved in India include Intas’ biosimilar (approved December 2024) and Zydus’ Sigrima™ (approved June 2024).  Sigrima™ is the subject of legal action in India by Roche, which is alleging infringement of patents IN268632 and IN464646.

Roche has recently indicated that biosimilar competition to Perjeta® is a bigger concern than it previously anticipated.  As well as the Indian proceedings against Zydus, Roche has also sued Shanghai Henlius and Organon in the US, alleging that their pertuzumab biosimilar, HLX11, infringes multiple US patents.

Amgen’s High-Concentration Adalimumab Biosimilar AU Approved

On 22 September 2025, Australia’s Therapeutic Goods Administration approved Amgen’s high-concentration Amgevita® (100mg/ml), biosimilar to AbbVie’s Humira® (adalimumab), in the following presentations:

  • 20mg/0.2mL (484565) and 40mg/0.4mL (484554) injection solution syringe; and
  • 40mg/0.4mL (484553) and 80mg/0.8mL (486685) injection solution syringe with a pen injector.

There are a number of other high-concentration adalimumab biosimilars approved in Australia, including Celltrion’s Yuflyma® (March 2022), Alvotech/Cipla’s Ciptunex®/Adalicip® (September 2022), Samsung Bioepis’ Hadlima® (February 2023) and Sandoz’s Hyrimoz® (May 2024).

In March 2025, Sandoz’s high-concentration Hyrimoz® (80 mg/0.8 mL injection, 0.8 mL pen) was PBS listed for all Humira® indications, which followed PBS-listing of the 40 mg/0.4 mL injection, 2 x 0.4 mL pen presentation in January 2025.

Biocon’s Biosimilar Aflibercept Recommended in India; Publicly Funded in Canada

On 21 September 2025, Medical Dialogues reported that Biocon has received recommendations from India’s Subject Expert Committee (SEC) under the Central Drugs Standard Control Organisation (CDSCO) to import and market its biosimilar to Regeneron/Bayer’s Eylea® (aflibercept) in India for multiple ophthalmic indications (in 40mg/ml vial form for injection).  Biocon is required to submit a Phase IV (post-marketing) clinical trial protocol to the CDSCO within 3 months of the grant of marketing authorisation.

Biocon also announced on 18 September 2025 that Yesafili® (aflibercept), in vial and prefilled syringe presentations, is now publicly funded on the Ontario Drug Benefit Formulary/Comparative Drug Index for the advanced treatment of patients with retinal diseases.

Yesafili® was reported to be the first aflibercept biosimilar approved in Canada in June 2025 and was launched in July 2025 under a March 2024 settlement between Biocon and Regeneron/Bayer.

Biocon’s Yesafili® was approved in Europe in September 2023 but is not yet on the market.  In April 2025, Biocon and Regeneron settled US BPCIA litigation regarding aflibercept, paving the way for a US launch of Yesafili® in the second half of 2026, or earlier under certain undisclosed circumstances.

MSD’s Subcutaneous Keytruda® (Pembrolizumab) Approved in US & Recommended in EU

On 19 September 2025, MSD announced that Keytruda Qlex™ (pembrolizumab and berahyaluronidase alfa-pmph; MK-3475A) has been approved by the FDA for subcutaneous use in adults across 38 indications, covering most solid tumour indications for Keytruda® (pembrolizumab).  MSD is planning a late September 2025 US launch for Keytruda Qlex™.

According to Business Korea, if Keytruda Qlex™ successfully penetrates the market, Alteogen, the developer of hyaluronidase technology used with the subcutaneous formulation, is expected to generate annual royalty income exceeding 1 trillion won.

The FDA had accepted MSD’s BLA for SC pembrolizumab in March 2025, with a target action date of 23 September 2025.

The good news for MSD comes a day after the European Medicines Agency (EMA) Committee for Medicinal Products for Human Use (CHMP) recommended a change to the marketing authorisation for MSD’s Keytruda®, adopting a new pharmaceutical form, solution for injection, associated with two new strengths (790 mg and 305 mg), together with subcutaneous use as a new route of administration.

MSD was sued by Halozyme in the US on 24 April 2025 in relation to SC pembrolizumab, with Halozyme alleging that it infringes 15 patents owned by Halozyme in relation to MDASE subcutaneous delivery platform.  The lawsuit followed reports in March 2025 that Halozyme had offered MSD an opportunity to licence its MDASE patents.  At the time, a spokesperson from MSD said the enzyme used in SC Keytruda® was “developed independently” from Halozyme and that MSD “strongly believe” that any Halozyme patents that attempt to cover the enzyme variant are invalid.

MSD has filed 14 petitions for post-grant review with the US Patent Trial and Appeal Board challenging the validity of US patents owned by Halozyme, a number of which are asserted in the litigation.  The petitions were filed between November 2024 and June 2025.  Petitions in relation to 5 patents have been instituted (US 11952600 (2 June 2025), US 12018298 (11 June 2025), US 12152262 (16 June 2025), US 12123035 (11 July 2025), US 12110520 (8 September 2025)), while others are pending.

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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