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Pearce IP BioBlast® for the week ending 16 January 2026

by , | Jan 20, 2026

Pearce IP provides weekly reports on global biosimilars activities in the Pearce IP BioBlast®.  Significant biosimilar activities for the week ending 16 January 2026 are set out below:


Aflibercept

16 January 2026 | EU | New Indication Alert: Bayer’s Aflibercept 8mg EU Approved for RVO
On 16 January 2026, Bayer announced that the European Commission has approved Eylea™ 8mg  (aflibercept 8mg, 114.3 mg/ml solution for injection) for macular oedema… Read more here.

Bevacizumab

On 13 January 2026, Shanghai Henlius Biotech announced that its Biologics Licence Application (BLA) for HLX04, biosimilar to Roche/Genentech’s Avastin® (bevacizumab)… Read more here.

Denosumab

9 January 2026 | BO | Boan Biotech’s Biosimilar Denosumab Approved in Bolivia
On 9 January 2026, Boan Biotech announced that it has received regulatory approval from Bolivia’s National Agency of Medicines and Health Technologies (AGEMED) for BA6101… Read more here.

Dupilumab

On 14 January 2026, Korea Biomedical Review reported that Korean-headquartered Chong Kun Dang has received approval from the European Medicines Agency (EMA) and the… Read more here.

Dupilumab, Guselkumab, Ixekizumab, Trastuzumab Deruxtecan, Vedolizumab, Ocrelizumab

14 January 2026 | Samsung Bioepis to Add 6 Biosimilars to Pipeline: Dupilumab, Guselkumab, Ixekizumab, Vedolizumab, Trastuzumab Deruxtecan & Ocrelizumab; 20 Biosimilars by 2030
At the J.P. Morgan Healthcare Conference on 14 January 2026, Samsung Epis Holdings announced the addition of six biosimilar candidates to Samsung Bioepis’ pipeline: dupilumab… Read more here.

Insulin Glargine

14 January 2026 | EU | Sandoz’s Biosimilar Insulin Glargine EU Approved
On 14 January 2026, Sandoz announced that the European Commission has approved Ondibta® (insulin glargine solution for injection in pre-filled pen), biosimilar to… Read more here.

Nivolumab

12 January 2026 | IN | Zydus Clear to Launch Nivolumab Biosimilar in India After BMS Injunction Overturned on Appeal
On 12 January 2026, an appellate Division of the High Court of Delhi issued its judgment overturning the grant of a preliminary injunction awarded to Bristol Myers Squibb (BMS) in July… Read more here.

Nivolumab, Ipilimumab

12 January 2026 | TW | New Indication Alert: BMS/Ono’s Opdivo®/Yervoy® Combo Approved in Taiwan for MSI-High/dMMR CRC
On 12 January 2026, Ono Pharmaceutical announced that the Taiwan Food and Drug Administration has approved a new indication for Opdivo® (nivolumab) intravenous infusion in… Read more here.

Pegfilgrastim

9 January 2026 | CA | CuraTeQ’s Pegfilgrastim Biosimilar Approved in Canada
On 9 January 2026, Aurobindo Pharma announced in a regulatory filing that its subsidiary, CuraTeQ Biologics, has received approval from Health Canada for Dyrupeg®, biosimilar… Read more here.

Ustekinumab

14 January 2026 | KR | Samsung Bioepis’ PFP Biosimilar Ustekinumab Approved in Korea
On 14 January 2026, Samsung Bioepis announced that Korea’s Ministry of Food and Drug Safety has approved a pre-filled pen formulation (PFP) of Epyztek®, biosimilar to J&J/Janssen’s… Read more here.

Biopharma Deals

15 January 2026 | Zydus Acquires Agenus’ Biologics Manufacturing Facilities in US $141M Deal
On 15 January 2026, Zydus Lifesciences Ltd and Agenus Inc. announced the closing of a deal in which Zydus acquired Agenus’ biologics manufacturing facilities in Emeryville and Berkeley… Read more here.
 
 
13 January 2026 | Celltrion Plans 41 Biosimilars By 2038; Opens First US Manufacturing Facility
On 13 January 2026, Celltrion revealed at the 44th Annual J.P. Morgan Healthcare Conference that it plans to commercialise up to 18 biosimilar products by 2030 and 41 products… 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.

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