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Pearce IP BioBlast® for the week ending 30 January 2026

Pearce IP provides weekly reports on global biosimilars activities in the Pearce IP BioBlast®.  Significant biosimilar activities for the week ending 30 January 2026 are set out below:


Aflibercept

30 January 2026 | EU | UK | Samsung Bioepis & Regeneron/Bayer Strike Ex-US/Canada Settlement for Aflibercept Biosimilar; 2026 Launches Planned
On 30 January 2026, Samsung Bioepis announced that it has secured a settlement and licence agreement with Regeneron and Bayer for the commercialisation of… Read more here.

 

29 January 2026 | EU | UK | JP | CA | 2026 Launches in EU & ROW For Alvotech’s Biosimilar Aflibercept Following Regeneron/Bayer Settlement
On 29 January 2026, Alvotech announced a settlement and licence agreement with Regeneron & Bayer in relation to all remaining patent disputes worldwide… Read more here.

Denosumab

On 19 January 2026, Hikma announced the US launch of Enoby™ and Xtrenbo™ (denosumab-gbde), biosimilars to Amgen’s Prolia® and Xgeva® respectively… Read more here.

Nivolumab

29 January 2026 | IN | BMS Seeks Leave to Appeal Zydus’ Win in Biosimilar Nivolumab Dispute
BMS has applied to the Supreme Court of India for leave to appeal against the 12 January 2026 decision of the High Court of Delhi appellate division, which allowed… Read more here.

 

29 January 2026 | EU | New Indication Alert: CHMP Recommends BMS’ Opdivo® Combo for Classical Hodgkin Lymphoma
On 29 January 2026, the European Medicine Agency’s Committee for Medicinal Products for Human Use (CHMP) recommended authorisation of BMS’s Opdivo®… Read more here.

Omalizumab

On 29 January 2026, Celltrion announced the Canadian approval of its high-dose Omlyclo® (omalizumab), biosimilar to Genentech/Novartis’ Xolair®, in 300mg… Read more here.

Pembrolizumab

30 January 2026 | AU | PBAC Recommends Broad, Multi-Indication Funding for MSD’s Keytruda® (Pembrolizumab)
At its December 2025 Intracycle Meeting (the outcomes of which were published on 30 January 2026), the Australian Pharmaceutical Benefits Advisory Committee… Read more here.

Tocilizumab

30 January 2026 | EU | Celltrion Launches Biosimilar Tocilizumab in Europe
On 30 January 2026, Celltrion announced that it has launched Avtozma®, biosimilar to Roche’s Actemra® (tocilizumab), in major European countries, including Germany… Read more here.

Ustekinumab

28 January 2026 | CA | Health Canada approves Dong-A ST’s Biosimilar Ustekinumab
On 28 January 2026, Korea Biomedical Review reported that Dong-A ST’s Imuldosa®, biosimilar to J&J/Janssen’s Stelara® (ustekinumab), has received marketing approval… Read more here.


Biopharma Deals

26 January 2026 | MENA | MS Pharma & Hetero Partner on 5 Biosimilars in Algeria
On 26 January 2026, MS Pharma announced that it has entered an exclusive agreement with Hetero Group in relation to the commercialisation in Algeria of 5 undisclosed… Read more here.

About Pearce IP

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

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

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

 

Naomi Pearce

Naomi Pearce

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

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

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

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

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.

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.

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