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Pearce IP BioBlast® for the week ending 24 April 2026

Pearce IP provides weekly reports on global biosimilars activities in the Pearce IP BioBlast®. Significant biosimilar activities for the week ending 24 April 2026 are set out below:


Adalimumab, Omalizumab, Ustekinumab

At the March 2026 PBAC Meeting (outcomes published on 24 April 2026), the Australian Pharmaceutical Benefits Advisory Committee (PBAC) recommended reimbursement… Read more here.

Denosumab

21 April 2026 | CA | Biocon’s Denosumab Biosimilars Approved in Canada
On 21 April 2026, Biocon announced that, on 3 April 2026, Health Canada approved Bosaya™ and Vevzuo™, biosimilars to Amgen’s Prolia® and Xgeva® (denosumab) respectively… Read more here.

Dupilumab

22 April 2026 | US | New Indication Alert: FDA Approves Regeneron/Sanofi’s Dupilumab for Children with Uncontrolled CSU
On 22 April 2026, Regeneron and Sanofi announced that Dupixent® (dupilumab) has been approved by the FDA for the treatment of children aged 2 to 11 years with chronic… Read more here.

Enfortumab vedotin

20 April 2026 | US | FDA Grants Priority Review of Pfizer/Astella’s sBLA for Enfortumab Vedotin Plus Pembrolizumab for MIBC Regardless of Cisplatin Eligibility
On 20 April 2026, Astellas Pharma and Pfizer announced that the FDA granted priority review of the sBLA for Astella Pharma/Pfizer’s Padcev™ (enfortumab vedotin-ejfv) in combination… Read more here.

Fremanezumab, Galcanezumab

On 16 April 2025, the US Court of Appeals for the Federal Circuit published its decision in an appeal by Teva Pharmaceuticals in proceedings commenced in September 2018 alleging… Read more here.

Golimumab

On 20 April 2026, PR Newswire reported that Health Canada has approved JAMP Pharma’s Upgolyv™, biosimilar to Janssen’s Simponi® (golimumab), for the treatment of chronic… Read more here.

Obinutuzumab

21 April 2026 | US | FDA Accepts Roche’s Obinutuzumab sBLA for SLE
On 21 April 2026, Roche announced that the FDA has accepted its supplemental Biologics License Application (sBLA) for Gazyva®/Gazyvaro® (obinutuzumab) for the treatment of… Read more here.

Ranibizumab, Nivolumab, Risankizumab

On 24 April 2026, the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) announced the outcomes of its April 2026 meeting, including positive… Read more here.

Ustekinumab

21 April 2026 | JP | Celltrion’s IV Ustekinumab Biosimilar Approved in Japan
On 21 April 2026, Celltrion announced that the intravenous (IV) formulation of Steqeyma® (ustekinumab), biosimilar to Janssen’s Stelara®, has been approved in Japan… Read more here.

Biopharma Deals

On 27 April 2026, Sun Pharmaceutical Industries Limited and Organon & Co announced that they have entered into a definitive agreement for the acquisition by Sun Pharma of all… Read more here.
 
On 22 April 2026, Amneal Pharmaceuticals and Kashiv BioSciences jointly announced that Amneal will acquire 100% of Kashiv BioSciences.  The deal (which is subject to approval… Read more here.

Biopharma News

On 27 April 2026, Samsung Bioepis published its 13th US Biosimilar Market Report, which has been released every quarter since April 2023.  The report provides an overview of the… 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.

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.

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