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Biosimilars Deals 2021

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Pearce IP Leaders Recommended in the 2026 Lexology Index for Intellectual Property

Aug 20, 2026

Two of Pearce IP’s leaders have been recommended by the Lexology Index: Intellectual Property 2026 which honours a small number of leading IP lawyers across 88 countries.

CEO and Founder, Naomi Pearce and Executive Helen Macpherson are recommended for Patents, and Copyright respectively.

The Lexology Index: IP is an in-depth guide to the international intellectual property legal market, recognising leading practitioners across patents, trademarks and copyright based on independent research and feedback from clients and peers.

Feedback from Lexology Index research includes:

“Naomi Pearce is a multiple-award winning principal and an inspiration to her team and to other lawyers….The size and strength of Naomi’s team and the quality of the clients and matters speaks volumes.”

Pearce IP’s Deputy CEO, Peter O’Sullivan, says:

“We are delighted to see both Naomi and Helen recognised in the Lexology Index: IP 2026.  Naomi’s deep expertise and strategic insight in complex IP matters, particularly across the life sciences sector, and Helen’s broad IP expertise, including her work in copyright and plant breeders’ rights, reflect the exceptional depth of talent and capability within our team.  Both are trusted advisers to clients navigating complex and commercially important IP challenges.”

 

About Pearce IP

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

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

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

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

 

Naomi Pearce

Naomi Pearce

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

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

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

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

Helen Macpherson

Helen Macpherson

Executive, Lawyer (Head of Litigation –Australia)

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

New Indication Alert: Ono/BMS’ Opdivo® (Nivolumab) IV approved in Taiwan for NSCLC

Aug 19, 2026

On 19 August 2026, Ono announced that it has received additional approval for Opdivo® (nivolumab) Intravenous Infusion from the Taiwan Food and Drug Administration (TFDA), for the neoadjuvant treatment of adult patients with resectable Non-Small Cell Lung Cancer (NSCLC) and no known epidermal growth factor receptor (EGFR) mutations or anaplastic lymphoma kinase (ALK) rearrangements in combination with platinum-doublet chemotherapy, followed by single-agent Opdivo® as adjuvant treatment after surgery.

Opdivo® was previously approved in Taiwan for a number of indications, including, in combination with BMS’ Yervoy® (ipilimumab), for unresectable or metastatic microsatellite instability-high (MSI-High) or mismatch repair deficient (dMMR) colorectal cancer (CRC) and unresectable or metastatic hepatocellular carcinoma, and in combination with cisplatin and gemcitabine, for unresectable or metastatic urothelial carcinoma.

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

Multiple nivolumab biosimilars are under development including Sandoz’s JPB898, Xbrane/Intas’ Xdivane™, Amgen’s ABP 206, Reliance Life Sciences’ RLS-Nivolumab, Enzene’s candidate, and Boan Biotech’s BA1104.

Pearce IP BioBlast® for the week ending 14 August 2026

Aug 18, 2026

Pearce IP provides weekly reports on global biosimilars activities in the Pearce IP BioBlast®.  Significant biosimilar activities for the week ending 14 August 2026 are set out below:

Aflibercept

On 13 August 2026, Bayer announced that China’s National Medical Products Administration (NMPA) has accepted for review its application for Eylea® (aflibercept) 8 mg… Read more here.

 

On 11 August 2026, Mabwell announced that it has entered into licensing and commercialisation agreements with unidentified partners in the Philippines, Vietnam and… Read more here.

Cetuximab, Evolocumab, Belimumab

On 17 August 2026, Sandoz and Shanghai Henlius Biotech announced that they have entered into a major development, manufacturing and commercialisation… Read more here.

Biopharma News

On 13 August 2026, Celltrion announced that the FDA has granted fast track designation to CT-P73, an antibody drug conjugate (ADC) for the treatment of… Read more here.

 

On 10 August 2026, Amneal Pharmaceuticals announced the completion of its acquisition of Kashiv BioSciences.  This follows the companies entering into… Read more here.

About Pearce IP

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

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

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

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

 

Naomi Pearce

Naomi Pearce

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

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

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

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

Chantal Savage

Chantal Savage

Special Counsel, Lawyer

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

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

Maliha Hoque

Maliha Hoque

Paralegal

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

FDA Approves Biocon’s Biosimilar Ustekinumab Autoinjector

Aug 18, 2026

On 18 August 2026, Biocon announced that it has received supplemental FDA approval for Yesintek®, biosimilar to Janssen’s Stelara® (ustekinumab), in a single-dose prefilled autoinjector format (45 mg/0.5 ml and 90 mg/ml).

Biocon first launched Yesintek® in the US in February 2025 (in PFS and vial presentations), following Yesintek®’s original FDA approval in November 2024.  The timing of Biocon’s US launch was governed by a US settlement and licence agreement with Janssen (entered in February 2024), including to resolve an Inter Partes Review Petition.

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

Bio-Thera & Avalon Partner on Biosimilar to Sanofi/Regeneron’s Dupixent® (Dupilumab) in MENA

Aug 18, 2026

On 18 August 2026, Avalon Pharmaceutical and Bio-Thera Solutions announced that they have entered into an exclusive licensing agreement for the commercialisation of Bio-Thera’s BAT2406, biosimilar to Sanofi/Regeneron’s Dupixent® (dupilumab), in MENA.

Under the agreement, China-based Bio-Thera is responsible for the development, manufacturing and supply of BAT2406, while Saudi-based Avalon Pharma is responsible for seeking regulatory approvals and commercialisation.  BAT2406 is currently in Phase I clinical trials.

Bio-Thera has also partnered with Costa-Rican-based SteinCares on BAT2406, entering an exclusive licence and commercialisation agreement in June 2025 for LATAM.

Biosimilar dupilumab is under development by multiple companies, including Samsung Bioepis (SB33 in pre-clinical development), Alvotech and Advanz (AVT19 in early development), Binnopharm and Mabwell (MOU announced December 2025 for Russia), Daewoong Pharmaceutical and Chime Biologics (agreement announced June 2026), and Formycon (FYB208 in early development).

In August 2025, CSPC Pharmaceutical announced that it received approval from China’s National Medical Products Administration (NMPA) to conduct clinical trials of its dupilumab injection.  In January 2026, Chong Kun Dang received approval from the EMA and UK MHRA for its phase 1 clinical trial protocol for CKD-706 (dupilumab).

Sam Chun Dang Settles Aflibercept Disputes with Regeneron & Bayer in Europe, Japan and South Korea

Aug 18, 2026

On 18 August 2026, Korea Biomedical Review reported that Sam Chun Dang (SCD) signed a settlement agreement with Regeneron and Bayer to resolve all patent disputes in Europe, Korea and Japan involving SCD411, biosimilar to Regeneron/Bayer’s Eylea® (aflibercept) 2 mg.  The financial terms of the settlement have not been disclosed.

Under the agreement, the parties will terminate all pending patent proceedings regarding aflibercept in the relevant jurisdictions, including:

It does not appear that the settlement addresses the pending Taiwanese patent infringement litigation commenced in February 2026 by Regeneron against the Taiwanese manufacturer of SCD411 (Mycenax Biotech Biopharmaceutical).

SCD411 was approved in vial and pre-filled syringe forms in Japan and Korea in September 2025.  It was launched in Korea as Vgenfli™ in December 2025, despite the pending patent infringement litigation commenced by Regeneron and Bayer, as no injunction was in place preventing sales.  SCD11 has not yet been launched in Japan, where the product is to be commercialised by Senju Pharmaceutical.

In Europe, SCD11 was approved as Vgenfli™ in August 2025, with Zaklady Farmaceutyczne Polpharma as the marketing authorisation holder.  SCD has announced licence agreements with an unnamed distributor for Austria, Germany, Italy, Spain and Switzerland (November 2023), and a further unnamed distributor for the UK, Belgium, Netherlands, Norway, Portugal, Sweden, Greece, Ireland and Finland (March 2024).

SCD and its US exclusive licensee, Fresenius Kabi, settled US aflibercept litigation with Regeneron/Bayer in February 2026.  The settlement permits Fresenius to launch SCD411/Vygenfree™ in the US at an undisclosed time.  The FDA accepted SCD’s application for SCD411 for review in December 2025 but the biosimilar has not yet been FDA-approved.

Regeneron, Bayer and Apotex, Sam Chun Dang’s commercialisation partner under an August 2023 agreement, settled their Canadian aflibercept litigation in June 2024.  Health Canada approved SCD11 as Aflivu™ in June 2025 and it was launched in July 2025.

 

Sandoz and Shanghai Henlius Enter US$100.5M Strategic Collaboration for Up to 10 Biosimilars Including Cetuximab, Evolocumab and Belimumab

Aug 17, 2026

On 17 August 2026, Sandoz and Shanghai Henlius Biotech announced that they have entered into a major development, manufacturing and commercialisation collaboration agreement, covering up to 10 biosimilars (including monoclonal antibodies and/or antibody-drug conjugates).

There are three products initially covered by the agreement:

  • HLX05-N, biosimilar to Eli Lilly/Merck KGaA’s Erbitux® (cetuximab), which is currently in clinical development;
  • HLX16, biosimilar to Amgen’s Repatha® (evolocumab), which is in “technical development”; and
  • biosimilar belimumab, referencing GSK’s Benlysta®, which is in “early development”.

Sandoz also has an option for HLXTE-HAase1001, a recombinant human hyaluronidase to be used in the development of a subcutaneously administered biosimilar.

Under the terms of the agreement, Henlius will be responsible for biosimilar development and manufacturing, while Sandoz will have certain commercialisation rights for the biosimilars outside of China.  For HLX05-N, Sandoz will have exclusive commercialisation rights in the US, Canada, EU, UK, Switzerland, Japan, Australia and New Zealand, and semi-exclusive rights in certain Asian and other countries.  The exclusive commercialisation territory for HLX16 and the belimumab biosimilar includes all markets worldwide outside China.

Sandoz will pay Henlius an upfront payment, milestone payments and a non-refundable option fee totalling up to US $322 million, with Henlius expected to receive US $100.5 million in 2026.

The companies have previously partnered on HLX13, biosimilar to BMS’ Yervoy® (ipilimumab).  Under an agreement announced in April 2025, Henlius is developing and manufacturing HLX13, while Sandoz has the exclusive commercialisation rights in the US, Europe, Canada, Japan, and Australia.  HLX13 entered clinical trials in November 2025.

FDA Grants Fast Track Designation for Celltrion’s ADCs

Aug 13, 2026

On 13 August 2026, Celltrion announced that the FDA has granted fast track designation to CT-P73, an antibody drug conjugate (ADC) for the treatment of patients with recurrent and metastatic cervical cancer who have previously received platinum based chemotherapy.

Fast-track designation is designed to accelerate the development and review of drugs intended to treat serious diseases and address unmet medical needs.  A company that receives fast track designation for a drug may have more frequent meetings with FDA regarding the development plan and collection of data needed to support drug approval, may submit sections of its BLA/NDA for “rolling review” and the drug may be eligible for accelerated approval and priority review if relevant criteria are met.

Celltrion has two other ADCs, CT-P70 and CT-P71, which have also secured FDA fast-track designation.  CT-P70 is being developed for the treatment of non-small cell lung cancer (NSCLC), while CT-P71 is undergoing evaluation in patients with locally advanced or metastatic urothelial carcinoma.  All three ADCs are in phase 1 clinical trials.

Bayer’s Eylea® (Aflibercept) 8 mg Application Accepted for Review in China for Macular Oedma Following RVO

Aug 13, 2026

On 13 August 2026, Bayer announced that China’s National Medical Products Administration (NMPA) has accepted for review its application for Eylea® (aflibercept) 8 mg (114.3 mg/ml solution) for injection) for the treatment of macular oedma following retinal vein occlusion (RVO).

Eylea® 8 mg is already approved in China for nAMD.  It has been approved to date in more than 60 markets for the treatment of nAMD and diabetic macular oedema (DME), including the US (August 2023).  It is also approved for the treatment of patients with macular oedema following RVO including in the US (November 2025), Europe (January 2026), the UK (February 2026), Korea (February 2026) and Japan (March 2026).

Eylea® 8 mg, known in the US as Eylea HD®, was jointly developed by Bayer and Regeneron.  Regeneron holds the exclusive rights to both 2 mg and 8 mg Eylea® in the US, while Bayer holds those outside the US, where the companies equally share the profits from sales of the products.

Alvotech is developing a high dose aflibercept biosimilar, AVT29.  In June 2024, Alvotech entered into an agreement with Advanz Pharma in relation to the commercialisation of AVT29 in Europe.  Teva holds commercialisation rights for AVT29 (and AVT06, aflibercept 2 mg) in the US.  Alvotech indicated in March 2026 that it expects to file the first regulatory submission for AVT29 sometime in 2026.  In April 2026, Alvotech commenced a phase 3 clinical trial to evaluate the efficacy and safety of AVT29 compared with Eylea HD® in patients with DME, with an estimated completion date of January 2028.

Amgen is also developing an 8 mg aflibercept biosimilar, ABP 938, and commenced a phase 3 clinical trial in May 2026, with an estimated completion date of January 2028.

All of Pearce IP NZ Leaders Ranked in Doyle’s Guide 2026 as Leading Intellectual Property Lawyers

Aug 12, 2026

All of Pearce IP’s New Zealand Executives have been recognised in the 2026 Doyle’s Guide – Leading Intellectual Property Lawyers (New Zealand) rankings.

Paul Johns is one of 11 lawyers honoured as a Leading Intellectual Property Lawyer.

Sally Paterson is one of 21 lawyers recognised as a Recommended Intellectual Property Lawyer.

Julie Ballance, recently retired from Pearce IP, is also recognised for the work she completed at Pearce IP.

Pearce IP launched in the New Zealand market in March 2025 and now holds the equal second-highest number of rankings in the 2026 Doyle’s Guide for New Zealand.

With only a select number of intellectual property lawyers recognised across New Zealand, it is an exceptional result for Pearce IP’s New Zealand practice – particularly less than two years after entering the market.

This result reflects the strength of Pearce IP’s New Zealand business and the reputation our team has built in a remarkably short time.

Naomi Pearce, Founder and CEO of Pearce IP, said:

“These rankings are a wonderful recognition of the exceptional talent we have in our New Zealand team. They demonstrate that expertise, hard work and an unwavering commitment to clients can quickly shake up an established market.

 

To achieve 100% of our Executives ranked, and the equal second highest number of rankings in Doyle’s Guide, in record time, is an accomplishment I am very proud of.

 

Congratulations to Sally and Paul and their teams.”

 

About Pearce IP

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

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

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

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

 

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.

Paul Johns

Paul Johns

Executive, Lawyer (Head of Litigation – New Zealand)

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

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

Pearce IP BioBlast® for the week ending 7 August 2026

Aug 11, 2026

Pearce IP provides weekly reports on global biosimilars activities in the Pearce IP BioBlast®.  Significant biosimilar activities for the week ending 7 August 2026 are set out below:

Aflibercept

On 10 August 2026, Samsung Bioepis announced the European launch of Opuviz®/SB15 (aflibercept), biosimilar to Regeneron/Bayer’s Eylea® 2mg in a…. Read more here.
 
On 3 August 2026, Biocon announced the US launch of Yesafili™ (aflibercept), biosimilar to Regeneron’s Eylea® 2 mg.  Yesafili™ was one of the first approved… Read more here.

Nivolumab

On 3 August 2026, Ono Pharmaceutical reported that Opdivo® (nivolumab) was approved by South Korea’s Ministry of Food and Drug Safety (MFDS) for… Read more here.

Pembrolizumab

On 10 August 2026, Samsung Bioepis announced that it has applied to Korea’s Ministry of Food and Drug Safety for approval of SB27, biosimilar to MSD’s… Read more here.

Semaglutide

On 5 August 2026, Novo Nordisk announced that The Hague District Court granted a preliminary injunction (PI) preventing Ceban Ziekenhuisfarmacie B.V… Read more here.

Vusolimogene oderparepvec

On 6 August 2026, Replimune announced that its vusolimogene oderparepvec-wtpg, formerly known as RP1 but newly branded as Tudriqev™, has received… Read more here.
 
 

About Pearce IP

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

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

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

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

 

Naomi Pearce

Naomi Pearce

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

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

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

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

Chantal Savage

Chantal Savage

Special Counsel, Lawyer

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

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

Maliha Hoque

Maliha Hoque

Paralegal

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

Mabwell Inks Licensing Deal for Aflibercept Biosimilar in Philippines, Vietnam and Malaysia

Aug 11, 2026

On 11 August 2026, Mabwell announced that it has entered into licensing and commercialisation agreements with unidentified partners in the Philippines, Vietnam and Malaysia for 9MW0813, biosimilar to Regeneron/Bayer’s Eylea® (aflibercept) 2mg.

Under the terms of the agreements, Mabwell and its partners will work collaboratively to advance the product’s registration and commercialisation in each country.  The announcement did not disclose the partners, financial terms or expected timeline for launch.

Mabwell’s biosimilar aflibercept was approved by China’s National Medical Products Administration (NMPA) in September 2025 for the treatment of diabetic macular oedema and neovascular (wet) age-related macular degeneration.

Mabwell has previously entered into licensing and commercialisation agreements for its denosumab biosimilars (Maiweijian™/9MW0321 and Mailishu™/9MW0311, biosimilars to Amgen’s Xgeva® and Prolia®) in the Philippines (July 2025 with UNILAB), Vietnam (March 2026 with undisclosed company) and Malaysia (April 2026 with undisclosed company).  Under these agreements, Mabwell is responsible for the development, production and commercial supply of the products whilst the partner is responsible for registration, marketing and commercialisation.

Samsung Bioepis Files First Korean Application for Biosimilar to MSD’s Keytruda® (Pembrolizumab)

Aug 10, 2026

On 10 August 2026, Samsung Bioepis announced that it has applied to Korea’s Ministry of Food and Drug Safety for approval of SB27, biosimilar to MSD’s Keytruda® (pembrolizumab).  According to Samsung Bioepis, this application puts it ahead of competitor pembrolizumab biosimilars in the Korean product approval process.

Samsung Bioepis announced positive results from global phase 1 and 3 clinical trials for SB27 on 29 June 2026, confirming its equivalence with Keytruda®.  At the time, Samsung Bioepis said it was the first developer of a pembrolizumab biosimilar to announce global phase 3 trial results.  The phase 1 and phase 3 trials were commenced in 2024, in an “overlap strategy” designed to accelerate SB27 development, with the studies expected to be completed by the end of 2026.

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

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

Other companies with pembrolizumab biosimilars in clinical trials include Amgen, mAbxience, Sandoz, 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.

Samsung Bioepis Launches PFS Aflibercept Biosimilar in Europe

Aug 10, 2026

On 10 August 2026, Samsung Bioepis announced the European launch of Opuviz®/SB15 (aflibercept), biosimilar to Regeneron/Bayer’s Eylea® 2mg in a pre-filled syringe (PFS) presentation (40 mg/mL).  Opuviz® was the third aflibercept biosimilar to be approved in the EU in November 2024 and was launched in Europe in a vial form in May 2026.

The original launch of Opuviz® followed a settlement agreement between Samsung Bioepis and Regeneron/Bayer announced in January 2026 under which Samsung Bioepis was permitted to launch SB15 in the UK from January 2026, in Europe from April 2026 and in other countries covered by the agreement from May 2026 (excluding Korea where it had already been on the market as Afilivu® since 2024).  Samsung Bioepis has a separate settlement agreement with Regeneron/Bayer for North America, permitting launch of SB15 in the US from January 2027.

Opuviz™ was the third aflibercept biosimilar to be approved in the EU (in November 2024) and has been approved elsewhere, including the UK (April 2025), the US (May 2024), Korea (as Afilivu®) (February 2024) and Australia (September 2025).

Other aflibercept biosimilars launched in UK/Europe, including in PFS form, include Sandoz’s Afqlir® (UK launch in November 2025), Celltrion’s Eydenzelt® (UK/EU launch in December 2025), Biocon’s Yesafili® (UK launch in January 2026), Alvotech’s Mynzepli® (UK launch January 2026) and Formycon/Klinge’s Ahzantive®/Baiama® (EU launch in May 2026).

Amneal Completes US$1.1B Acquisition of Kashiv BioSciences

Aug 10, 2026

On 10 August 2026, Amneal Pharmaceuticals announced the completion of its acquisition of Kashiv BioSciences.  This follows the companies entering into a definitive agreement in April 2026, and is in line with their expectations of a H2/2026 closing.

The acquisition combines Kashiv’s expertise in biosimilar development and manufacturing with Amneal’s scale and commercialisation capabilities.  According to Amneal, it creates “an integrated biosimilars business that can launch multiple biosimilars each year” and extend Amneal’s “growth profile into the next decade”.

The acquisition included a USD $375 million cash transaction and USD $375 million in equity payable at closing, with up to USD $350 million based on achievement of certain regulatory milestones, potential royalties based on commercial milestones, and funding of operations through closing.

Kashiv and Amneal have previously entered strategic partnerships in relation to biosimilars in the US, including Fylnetra™ (biosimilar pegfilgrastim) in May 2022 and ADL018 (biosimilar omalizumab) in 2024.

The acquisition brings together Kashiv’s biosimilar pipeline (including Releuko™ (filgrastim-ayow) (FDA-approved March 2022), abatacept/KSHB002 (in clinical trials), certolizumab pegol and nivolumab (pre-clinical) and pembrolizumab (cell line and process development)) with Amneal’s biosimilar pipeline (including Alymsys® (bevacizumab) (FDA approved April 2022) and the exclusive US rights to mAbxience’s Boncresa™ and Oziltus™ (MB09), biosimilars to Amgen’s Prolia® and Xgeva® (denosumab) (FDA approved December 2025)).

FDA approves Replimune’s RP1 for Advanced Melanoma

Aug 6, 2026

On 6 August 2026, Replimune announced that its vusolimogene oderparepvec-wtpg, formerly known as RP1 but newly branded as Tudriqev™, has received accelerated approval from the FDA for the treatment of adults with unresectable advanced cutaneous melanoma who experienced disease progression on an anti-PD-1 antibody-based regimen.

Tudriqev™ is a is a genetically modified herpes simplex virus, type 1 (HSV-1) oncolytic viral therapy that is administered via direct intra-tumour injection into superficial and deep and/or visceral lesions.

The FDA approval comes despite the FDA’s 30 July 2026 briefing document for Replimune’s third submission of the Biologics License Application (BLA) for RP1 in combination with BMS’ Opdivo® (nivolumab) for the treatment of advanced melanoma.

The FDA’s briefing document stated in relation to Replimune’s IGNYTE study:

  • The study’s “criteria for response assessment confounds interpretation of the reported efficacy results and limits FDA’s ability to verify the reported results”;
  • “The objective response data from the single-arm IGNYTE study are not of sufficient magnitude to overcome concerns about the contribution of effect, particularly in the absence of a reliable historical control, and therefore it cannot be determined whether RP1 contributes to any observed effect when administered in combination with nivolumab”; and
  • “The overall survival analysis from the single-arm IGNYTE study is not interpretable”.

According to Replimune, continued approval of Tudriqev™ may be contingent on verification of its clinical benefit in confirmatory trials.  A confirmatory Phase 3 trial, IGNYTE-3, is ongoing and assessing Tudriqev™ in combination with nivolumab (NCT06264180).

Dutch Court Grants Preliminary Injunction Preventing Sale of Compounded Semaglutide Nasal Spray

Aug 5, 2026

On 5 August 2026, Novo Nordisk announced that The Hague District Court granted a preliminary injunction (PI) preventing Ceban Ziekenhuisfarmacie B.V. (a retail pharmacy based in the Netherlands) from selling a compounded semaglutide nasal spray under the name Semanova.  To date, no nasal spray formulations of semaglutide have been given regulatory approval anywhere in the world.

Novo Nordisk’s European compound patent for semaglutide (EP 1 863 839) expired in March 2026.  In the Netherlands, Novo Nordisk holds a supplementary protection certificate (SPC) extending patent protection over semaglutide until 19 March 2031.

The court found that Ceban’s nasal spray infringed Novo Nordisk’s Dutch SPC for semaglutide.  As a result, the court has ordered Ceban to cease the infringing activities, remove product listings, disclose commercial supply chain information and reimburse Novo Nordisk’s legal costs.

According to JUVE Patent, Ceban’s defence relied on the pharmacy compounding exemption under Article 54c(e) of the Dutch Patent Act, which permits small-scale compounding for individual patients pursuant to a medical prescription.  The court found that Ceban’s resale of nasal sprays to other pharmacies and registration in the Dutch drug database fell outside of this exemption.

In Europe, Novo Nordisk markets semaglutide as Wegovy® for weight loss (subcutaneous injectable (0.25 mg, 0.5 mg, 1 mg, 1.7 mg or 2.4 mg standard dose or 7.2 mg high dose) or oral pill), and as Ozempic® (once-weekly subcutaneous injectable) and Rybelsus® (once-daily oral pill) for the treatment of type 2 diabetes.

Generic semaglutide products are yet to launch in Europe but have launched in India in March 2026 (including by Dr Reddy’s, Zydus, Alkem, Sun Pharma and Glenmark) and Canada in May 2026 (by Apotex and Dr Reddy’s).  Apotex received the first US FDA Tentative Approval for its generic semaglutide ANDA in April 2026, giving it an opportunity to be one of the first to launch generic Ozempic® in the US following expiry of Novo Nordisk’s exclusivity/patents and subject to ongoing US patent infringement litigation.

Pearce IP BioBlast® for the week ending 31 July 2026

Aug 4, 2026

Pearce IP provides weekly reports on global biosimilars activities in the Pearce IP BioBlast®.  Significant biosimilar activities for the week ending 31 July 2026 are set out below:

Insulin Aspart

On 30 July 2026, On 30 July 2026, Chicago-headquartered Meitheal Pharmaceuticals announced that the FDA has approved Garzulys™…. Read more here.

Nivolumab

On 29 July 2026, the EPO published the Board of Appeal’s decision of 6 May 2026 upholding the Opposition Division’s 13 March 2024 revocation… Read more here.

Pertuzumab

On 26 July 2026, Roche and Genentech commenced BPCIA proceedings in the US District Court in New Jersey against Biocon in relation to Biocon’s Bmab 1500… Read more here.

Rituximab

On 1 August 2026, the Economic Times reported that the FDA has approved Dr Reddy’s biosimilar to Genentech’s Rituxan® (rituximab). The product will be… Read more here.

Semaglutide

On 29 July 2026, Sandoz announced that Brazil’s Agência Nacional de Vigilância Sanitária (ANVISA) has approved Owozy® (semaglutide), a generic version… Read more here.

Trastuzumab deruxtecan

On 28 July 2026, AstraZeneca announced that India’s Central Drugs Standard Control Organisation (CDSCO) has approved an indication extension for… Read more here.

Ustekinumab

On 29 July 2026, Biocon announced that it has received Notice of Compliance (NOC) approval from Health Canada for ustekinumab (Yesintek®)… Read more here.

Vedolizumab

On 31 July 2026, Polpharma Biologics and Fresenius Kabi announced that Polpharma’s Biologics License Application (BLA) and Marketing Authorisation… Read more here.
 
On 31 July 2026, judgment was published in relation to procedural matters in proceedings commenced earlier this year in the High Court of… Read more here.

Biopharma News

On 30 July 2026, Seoul Economic Daily reported that Celltrion is partnering with Korean-headquartered G2GBIO to convert antibody drugs to subcutaneous… Read more here.
 
On 29 July 2026, Alvotech announced that the US FDA has closed its inspection of Alvotech’s manufacturing facility in Reykjavik, Iceland with the… Read more here.
 

About Pearce IP

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

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

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

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

 

Naomi Pearce

Naomi Pearce

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

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

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

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

Chantal Savage

Chantal Savage

Special Counsel, Lawyer

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

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

Maliha Hoque

Maliha Hoque

Paralegal

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

New Indication Alert: BMS/Ono’s Opdivo® (Nivolumab) Approved in Korea for NSCLC

Aug 3, 2026

On 3 August 2026, Ono Pharmaceutical reported that Opdivo® (nivolumab) was approved by South Korea’s Ministry of Food and Drug Safety (MFDS) for neoadjuvant treatment of adult patients with resectable non-small cell lung cancer (NSCLC) and no known epidermal growth factor receptor (EGFR) mutations or anaplastic lymphoma kinase (ALK) rearrangements in combination with platinum-doublet chemotherapy, followed by single-agent as adjuvant treatment after surgery.

Ono retains commercialisation rights for Opdivo® in Japan, South Korea and Taiwan under a 2011 agreement with BMS, while BMS has the rights elsewhere in the world.

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

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

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

Biocon’s Yesafili™ (Aflibercept) Launches as Second Eylea® Biosimilar on US Market

Aug 3, 2026

On 3 August 2026, Biocon announced the US launch of Yesafili™ (aflibercept), biosimilar to Regeneron’s Eylea® 2 mg.

Yesafili™ was one of the first approved interchangeable aflibercept (2 mg) biosimilars in the US in May 2024.  Biocon and Regeneron settled US BPCIA litigation regarding aflibercept in April 2025, paving the way for a US launch of Yesafili™ in the second half of 2026.

Yesafili™ is only the second aflibercept biosimilar on the US market, following the launch of Amgen’s Pavblu® in October 2024, after the US Court of Appeals for the Federal Circuit’s denial of Regeneron’s application for an injunction in relation to that biosimilar. The FDA has not designated Pavblu® as interchangeable with Eylea®.

Biocon’s launch of Yesafili™ leads a stream of upcoming aflibercept biosimilar launches in the US resulting from litigation settlements, including Formycon/Klinge’s Ahzantive® (approved June 2024, due to launch Q4/2026), Sandoz’s Enzeevu® (approved August 2024, due to launch Q4/2026), Celltrion’s Eydenzelt® (approved October 2025, due to launch Q4/2026), and Alvotech/Teva’s AVT06 due to launch Q4/2026, subject to regulatory approval).

In January 2026, Biocon reached a settlement and licence agreement with Regeneron and Bayer for Yesafili™ in Europe and ROW, permitting Biocon to commercialise Yesafili™ in Europe/ROW from March 2026, other than in the UK (where it launched in January 2026) and Canada (where it launched in July 2025 as a result of a Canadian settlement).

Dr Reddy’s Biosimilar to Genentech’s Rituxan® (Rituximab) US-Approved Following 2024 Settlement and FDA CRL

Aug 1, 2026

On 1 August 2026, the Economic Times reported that the FDA has approved Dr Reddy’s biosimilar to Genentech’s Rituxan® (rituximab).  The product will be commercialised in the US by Fresenius Kabi.

The FDA approval follows a Complete Response Letter (CRL) issued to Dr Reddy’s by the FDA in April 2024 regarding its biosimilar rituximab BLA.  The CRL related to the results of regulatory inspections at Dr Reddy’s Biologics facility in 2023, as well as “certain aspects pertaining to the BLA”.  Also in 2024, a settlement was reached in relation to patent infringement claims brought in the US District Court for the District of New Jersey by Genentech, Roche and Biogen against Dr Reddy’s and Fresenius Kabi in respect of Dr Reddy’s rituximab.  The terms of the settlement are confidential.

Dr Reddy’s rituximab biosimilar is already commercialised in more than 28 markets, including India (marketed as Reditux®) and Europe (marketed as Ituxredi®), and has also received marketing approval in Switzerland and Canada.

Rituxan® was first approved in the US on 26 November 1997 and was one of the first mAbs to face biosimilar competition.  There are three rituximab biosimilars currently on the US market: Teva and Celltrion’s Truxima® (launched in May 2020, interchangeability status announced July 2026), Pfizer’s Ruxience® (launched in January 2020) and Amgen and Allergan’s Riabni™ (approved by the FDA in December 2020).

Fresenius Kabi, Advanz, Accord & Samsung Bioepis in London Court with Takeda/Millennium Over Vedolizumab Biosimilars

Jul 31, 2026

On 31 July 2026, judgment was published in relation to procedural matters in proceedings commenced earlier this year in the High Court of England and Wales (Patents Court) by each of Fresenius Kabi, Advanz Pharma, Accord Healthcare and Samsung Bioepis (Biosimilar Claimants) against Millennium Pharmaceuticals, a Takeda subsidiary.  The Biosimilar Claimants are seeking to clear the way for the UK launch of their biosimilar vedolizumab products, referencing Takeda’s Entyvio®.

In each of the proceedings, the Biosimilar Claimant has applied for the revocation of various Millenium patents and/or for non-infringement declarations or Arrow declarations (that a particular product/process was obvious at the relevant priority date).  The patents at issue concern dosing regimens in respect of vedolizumab (EP (UK) 3329965, 3311834 and pending patent applications EP4378484 and EP4438625)) and formulations for vedolizumab (EP (UK) 2704798 and 4403579).

The four proceedings are being heard together and the Biosimilar Claimants have agreed to use their “best endeavours” to align the grounds of invalidity they are relying on by 10 September 2026.  A trial is currently scheduled for April 2027.

The July 2026 judgment primarily concerned a dispute between Advanz and Millenium/Takeda in relation to the confidentiality regime applying to information about Advanz’s IV and SC vedolizumab formulations.  The parties had agreed that only UK lawyers and two in-house personnel should have access to Advanz’s confidential information and that the in-house individuals should be prohibited from being involved in claim drafting prior to the grant of a patent.  Advanz argued that the restriction on claim drafting should also extend to claim amendments or auxiliary requests in foreign proceedings or the European Patent Office for granted patents.  In his July 2026 judgment, Mr Justice Mellor concluded that the extended prohibition sought by Advanz should be imposed.

Advanz is the UK, EU and Swiss commercialisation partner for Alvotech’s intravenous vedolizumab biosimilar, AVT16, under a 2023 licence agreement.  In June 2026, Alvotech announced that its BLA for AVT16 was the first to be accepted for review by the FDA.  Alvotech also has a subcutaneous vedolizumab biosimilar under development, AVT80.

Fresenius Kabi is commercialising Polpharma Biologics’ PB016 (vedolizumab) in the UK, under a global licensing agreement (excluding MENA region) entered in August 2025.  On the same date on which the July 2026 judgment was published, Polpharma/Fresenius announced that the Marketing Authorisation Application for PB016 had been accepted for review by the European Medicines Agency (with the corresponding BLA accepted by the FDA).

Accord Healthcare’s parent company, Intas, received approval to conduct a Phase 1 bioequivalence study for its vedolizumab biosimilar, INTP53, in February 2025.  Samsung Bioepis’ vedolizumab biosimilar will be commercialised (except in certain Asian countries) by Sandoz under a global licence, development and commercialisation agreement announced in March 2026.

Polpharma/Fresenius Kabi’s Biosimilar Vedolizumab Accepted for Review in US & EU

Jul 31, 2026

On 31 July 2026, Polpharma Biologics and Fresenius Kabi announced that Polpharma’s Biologics License Application (BLA) and Marketing Authorisation Application (MAA) for PB016 (vedolizumab), biosimilar to Takeda’s Entyvio®, have been accepted for review by the FDA and European Medicines Agency (EMA), respectively.  In both regions, PB016 is delivered in a lyophilised vial for intravenous administration and is indicated for the treatment of adults with moderately to severely active ulcerative colitis and Crohn’s disease.

The biosimilar was developed by Polpharma Biologics, and Fresenius Kabi holds the exclusive commercialisation rights (excluding the MENA region) under a global licensing agreement announced in August 2025.  Polpharma entered into a licensing agreement with MS Pharma for commercialisation of PB016 (and other biosimilars) in the MENA region in September 2025.

In February 2024, Polpharma announced that PB016 demonstrated pharmacokinetic and pharmacodynamic equivalence to Entyvio®.  A phase 3 trial comparing PB016 to Entyvio® in patients with ulcerative colitis was also undertaken.

The first FDA acceptance of a BLA for a vedolizumab biosimilar was in June 2026, for Alvotech’s AVT16 (lyophilised vial for IV administration).  AVT16 will be commercialised by Teva under a strategic partnership entered in August 2020 and expanded in 2023.  Alvotech also has a subcutaneous vedolizumab biosimilar under development (AVT80), with positive results from a PK study for the product announced in February 2026.

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

Celltrion & G2GBIO Collaborate on High Concentration SC Antibody Drug Development

Jul 30, 2026

On 30 July 2026, Seoul Economic Daily reported that Celltrion is partnering with Korean-headquartered G2GBIO to convert antibody drugs to subcutaneous injection formulations.  The companies have signed a strategic memorandum of understanding, including a material transfer agreement, for “ultra-high concentration antibody SC formulation platform technology”.

As part of the collaboration, Celltrion and G2GBIO will evaluate G2GBIO’s InnoBioLAMP platform using Celltrion’s antibody assets and will explore joint development opportunities.  The InnoBioLAMP platform uses microparticle technology to convert intravenous antibody therapies into subcutaneous formulations.

In March 2026, G2GBIO entered into a research collaboration and licence agreement with Samsung Bioepis and its sister company, Epis NexLab, to develop long-acting semaglutide, with an option for Samsung Bioepis to licence another undisclosed G2GBIO asset.

Product specific reports based on extracts from our BioBlast® database

adalimumab | Humira® | AbbVie

aflibercept | Eylea® | Regeneron

bevacizumab | Avastin® | Roche/Genentech

cetuximab | Erbitux® | Eli Lilly/Merck KGaA

daratumumab | Darzalex® | J&J

darbepoetin | Aranesp® | Amgen

denosumab | Prolia®/Xgeva® | Amgen

dupilumab | Dupixent® | Sanofi-Aventis

eculizumab | Soliris® | Alexion

etanercept | Enbrel® | Amgen

faricimab | Vabysmo® | Roche

filgrastim (GCSF) | Neupogen® | Amgen

golimumab | Simponi® | Janssen

guselkumab | Tremfya® | Janssen

infliximab | Remicade® | Johnson & Johnson

ixekizumab | Taltz® | Eli Lilly

lecanemab | Leqembi® | Eisai/Biogen

liraglutide | Victoza® /Saxenda® | Novo Nordisk

natalizumab | Tysabri® | Biogen/Elan

nivolumab | Opdivo® | BMS

olaparib | Lynparza® | AstraZeneca/Merck

omalizumab | Xolair® | Genentech / Novartis

pegfilgrastim | Neulasta® | Amgen

pembrolizumab | Keytruda® | MSD

pertuzumab | Perjeta® | Roche

ranibizumab | Lucentis® | Genentech

regdanvimab | Regkirona® | Celltrion

risankizumab | Skyrizi® | AbbVie

rituximab | Rituxan®/MabThera® | Genentech/Biogen

secukinumab | Cosentyx® | Novartis

semaglutide | Wegovy®/Ozempic® | Novo Nordisk

tocilizumab | Actemra® | Roche

trastuzumab | Herceptin® | Roche/Genentech

ustekinumab | Stelara® | Johnson & Johnson/Janssen

vedolizumab | Entyvio® | Takeda

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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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