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Pearce IP BioBlast® for the week ending 18 September 2026

Pearce IP provides weekly reports on global biosimilars activities in the Pearce IP BioBlast®.  Significant biosimilar activities for the week ending 18 September 2026 are set out below:


Emicizumab

On 18 September 2026, Sandoz and mAbxience announced they have entered a licensing, development, manufacturing and commercialisation agreement in relation… Read more here.

Etanercept

In a judgment published on 15 September 2026 (but delivered on 27 August 2026), the Federal Court of Australia found that Pfizer had failed to establish that Samsung… Read more here.

Gerfurliumab, Denecimig, Pembrolizumab, Ocrelizumab

On 18 September 2026, the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) announced the outcomes of its September 2026… Read more here.

Golimumab

On 16 September 2026, Teva filed an application seeking declaratory judgment of non-infringement and invalidity in relation to 14 Janssen patents asserted against… Read more here.

Infliximab

On 15 September 2026, Celltrion announced that it has filed an Investigational New Drug (IND) application with the FDA for a Phase 4 clinical trial of high-dose… Read more here.

Nivolumab

During a presentation on 15 September 2026, Amgen confirmed that it has filed an abbreviated Biologics License Application (aBLA) with the FDA for a biosimilar… Read more here.

 

On 15 September 2026, The Economic Times reported that Dr Reddy’s has launched Nivorz™, biosimilar to BMS’ Opdivo® (nivolumab), in India.  Nivorz™ will be… Read more here.

Omalizumab, Pertuzumab

On 18 September 2026, the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) announced the outcomes of its September… Read more here.

Pembrolizumab

On 16 September 2026, MSD’s subcutaneous pembrolizumab was approved in Japan under the name Keyject™.  Keyject™ (pembrolizumab and berahyaluronidase alfa)… Read more here.

 

As previously reported, since November 2024, MSD has filed a number of petitions for review with the US Patent Trial and Appeal Board (PTAB) challenging the validity… Read more here.

Pembrolizumab, Nivolumab

On 17 September 2026, India-based contract development and manufacturing organisation (CDMO) Shilpa Biologicals announced that it has signed an exclusive licence… Read more here.

Semaglutide

On 18 September 2026, Sandoz announced that Health Canada has approved Sandoz® Semaglutide, a generic version of Novo Nordisk’s Ozempic® (semaglutide)… Read more here.

Trastuzumab deruxtecan, Datopotamab deruxtecan

On 16 September 2026, Daiichi Sankyo announced that Japan’s Ministry of Health, Labour and Welfare has approved Enhertu® (trastuzumab deruxtecan) and Datroway®… Read more here.

Biopharma News

On 21 September 2026, Sandoz Group AG joined the Swiss Market Index (SMI), Switzerland’s leading blue-chip equity index.  The milestone was foreshadowed in an… 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 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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