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Pearce IP BioBlast® for the week ending 7 November 2025

by , , | Nov 11, 2025

Pearce IP provides weekly reports on global biosimilars activities in the Pearce IP BioBlast®.  Significant biosimilar activities for the week ending 7 November 2025 are set out below:


Aflibercept

10 November 2025 | UK | SPC Waiver Win for Alvotech – UK Court Rejects Regeneron/Bayer Injunction Against Alvotech and its CMO
On 10 November 2025, Alvotech announced that the UK High Court has rejected Regeneron/Bayer’s request for an injunction to prevent UK manufacturing activities under the… Read more here.

Bevacizumab

3 November 2025 | US | Outlook Therapeutics Resubmits Ophthalmic Bevacizumab BLA to FDA
On 3 November 2025, Outlook Therapeutics announced that it has re-submitted its Biologics Licence Application (BLA) to the US FDA for its ophthalmic formulation… Read more here.

Denosumab

On 7 November 2025, Boan Biologics announced that the UK Medicines and Healthcare products Regulatory Agency (MHRA) has accepted its marketing… Read more here.
 
6 November 2025 | US | Amgen Commences 2 Further BPCIA Denosumab Litigations – Against Alvotech/Dr Reddy’s & Amneal/mAbxience
On 6 November 2025, Amgen filed two separate BPCIA litigation suits in the US District Court for the District of New Jersey, against each of Dr Reddy’s/Alvotech… Read more here.

Golimumab

6 November 2025 | UK | Alvotech/Advanz’s Golimumab UK Approved
On 6 November 2025, Alvotech and Advanz Pharma announced that the UK Medicines and Healthcare products Regulatory Agency (MHRA) has approved… Read more here.
 
2 November 2025 | US | FDA Issues CRL for Alvotech’s Biosimilar Golimumab
On 2 November 2025, Alvotech announced that the FDA has issued a complete response letter (CRL) for Alvotech’s Biologics Licence Application (BLA) for… Read more here.

Nivolumab

4 November 2025 | First Patient Enrolled in Phase I/III Clinical Trials for Xbrane/Intas’ Nivolumab Biosimilar
On 4 November 2025, Xbrane Biopharma announced that the first patient has been enrolled in the clinical trial of Xdivane™, biosimilar to BMS’ Opdivo® (nivolumab)… Read more here.

Olaparib

On 7 November 2025, Medical Dialogues reported that Zydus Lifesciences has received tentative approval from the FDA for olaparib tablets, 100 mg and 150 mg… Read more here.

Ranibizumab, Brolucizumab

20 October 2025 | KR | Santen Pharmaceuticals Inks South Korea Deal with Novartis for Lucentis® and Beovu®
On 20 October 2025, Santen Pharmaceutical announced that Santen Korea has entered into a promotion and distribution agreement in South Korea with Novartis… Read more here.

Ustekinumab

6 November 2025 | EU | Samsung Bioepis and J&J Settle Dispute Over EU Biosimilar Ustekinumab
On 6 November 2025, Samsung Bioepis announced that it has signed a settlement and licence agreement with Johnson & Johnson (J&J) in relation to the European… Read more here.
 
6 November 2025 | US | Hikma Launches Biosimilar Ustekinumab in the US
On 6 November 2025, Hikma Pharmaceuticals announced its US launch of Starjemza™, biosimilar to J&J/Janssen’s Stelara® (ustekinumab).  This is the first biosimilar… Read more here.

BioPharma Deals

4 November | FR | Sandoz Acquires Continuous Manufacturing Company Just-Evotec for USD 350M
On 4 November 2025, Sandoz and Evotec SE announced they have signed an agreement for Sandoz’s acquisition of 100% of Just-Evotec Biologics EU SAS… 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.

Nathan Kan

Nathan Kan

Lawyer

Nathan is a lawyer specialising in life sciences, providing legal advice and litigation support across intellectual property and commercial disputes. He is passionate about the intersection of law and science, and during his time with the Science and Technology Law Association at the University of Melbourne, he helped lead events, workshops and publications across STEM fields including life sciences, AI and digital transformation.

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