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Pearce IP BioBlast® for the week ending 1 May 2026

Pearce IP provides weekly reports on global biosimilars activities in the Pearce IP BioBlast®. Significant biosimilar activities for the week ending 1 May 2026 are set out below:


Bevacizumab

On 1 May 2026, Aurobindo announced that its subsidiary, CuraTeQ Biologics, received Canadian approval for Bevqolva™ (bevacizumab), biosimilar to Genentech’s Avastin®… Read more here.

Pembrolizumab

At its meeting on 22 April 2026, the Subject Expert Committee (SEC) under India’s Central Drugs Standard Control Organisation (CDSCO) recommended approval of Enzene’s… Read more here.

Pembrolizumab, Nivolumab, Abatacept, Certolizumab

During its investor call on 22 April 2026, Amneal confirmed that, following its acquisition of Kashiv Biosciences, it is expecting to have 6 biosimilars launched in the US by 2027… Read more here.

Pertuzumab

On 29 April 2026, the European Commission approved Shanghai Henlius and Organon’s Poherdy® (pertuzumab) as the first biosimilar to Genentech/Roche’s Perjeta®… Read more here.

Ranibizumab

On 30 April 2026, Xbrane announced that it has resubmitted its BLA for biosimilar ranibizumab to the FDA following a Complete Response Letter (CRL) received in October… Read more here.

Semaglutide

Following the March 2026 launch of several generic equivalents of Novo Nordisk’s Ozempic® (semaglutide) in India and the “tentative approval” of Apotex’s generic… Read more here.

Tocilizumab

On 29 April 2026, Gedeon Richter announced that the European Commission has granted marketing authorisation for Tuyory ®, biosimilar to Roche’s RoActemra® (tocilizumab)… Read more here.
 
On 28 April 2026, Celltrion announced the launch of Avtozma®/CT-P47, biosimilar to Roche’s Actemra®(tocilizumab), in Japan.  Avtozma® is the first tocilizumab biosimilar… Read more here.

Trastuzumab

On 30 April 2026, Celltrion announced that it had submitted an application to the European Medicines Agency (EMA) for Herzuma® SC/CT-P6 SC, biosimilar to Roche’s​… Read more here.

Ustekinumab

On 1 May 2026, Janssen/Johnson & Johnson (J&J) announced that, on 15 April 2026, the FDA approved Stelara® (ustekinumab) for the treatment of children two years and older with… Read more here.

Zanidatamab, Tislelizumab

On 27 April 2026, Jazz Pharmaceuticals announced that the FDA accepted for priority review a supplemental Biologics License Application (sBLA) for Ziihera® (zanidatamab-hrii) in… Read more here.

 

About Pearce IP

Pearce IP is a privately owned and independent patent and trade mark attorney firm, specialising in life sciences, pharmaceuticals and biotechnology, with lawyers and attorneys across Australia and New Zealand, supporting clients globally.

As an independent firm, Pearce IP provides partner-led, conflict-free advice to organisations ranging from early-stage innovators to multinational companies.

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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