Pearce IP provides weekly reports on global biosimilars activities in the Pearce IP BioBlast®. Significant biosimilar activities for the week ending 1 August 2025 are set out below:
Aflibercept, Denosumab, Tocilizumab
30 July 2025 | AU | Four Celltrion Biosimilars on November PBAC Agenda in AU
On 30 July 2025, Australia’s Pharmaceutical Benefits Advisory Committee (PBAC) published its November 2025 agenda, at which four Celltrion biosimilars will be considered… Read more here.
Denosumab
2 August 2025 | IN | Phase I Clinical Trial Results for Intas’ Denosumab Biosimilar Accepted by CDSCO
As reported by Medical Dialogues, India’s Central Drugs Control Organisation (CDSCO) has reviewed and accepted without objection a final Clinical Study Report (CSR) submitted by Intas… Read more here.
1 August 2025 | AU | Sandoz’s Denosumab and Celltrion’s Ustekinumab & Omalizumab PBS-Listed in AU
On 1 August 2025, the Pharmaceutical Benefits Scheme (PBS) published its Summary of Changes, which includes the following… Read more here.
Nivolumab, Ipilimumab
25 July 2025 | TW | New Indication Alert: Opdivo®/Yervoy® Combo Approved in Taiwan for HCC
On 25 July 2025, Ono Pharmaceutical Co announced the additional approval by the Taiwan Food and Drug Administration (TFDA) of Opdivo® (nivolumab) in combination with Yervoy® (ipilimumab) as… Read more here.
Pertuzumab
25 July 2025 | IN | High Court of Delhi Declines to Order Zydus to Disclose Pertuzumab Biosim Manufacturing Process
On 25 July 2025, the High Court of Delhi issued an interlocutory judgment in ongoing patent infringement litigation brought by Roche to prevent Zydus from launching Sigrima®, biosimilar to… Read more here.
Pertuzumab, Omalizumab
24 July 2025 | Roche Revises Expectations of Biosimilar Competition to Pertuzumab and Omalizumab
Roche’s 2025 second-quarter earnings call included disclosure that it now expects biosimilar competition to Perjeta® (pertuzumab) and Xolair® (omalizumab) in 2026, sooner than previously… Read more here.
Biosimilar Deals
30 July 2025 | FR | Sandoz to Acquire Just-Evotec’s Development & Manufacturing Facility for USD 300M
On 30 July 2025, Sandoz and Evotec announced that they have signed a non-binding term sheet relating to Sandoz’s potential acquisition of Just-Evotec Biologics EU and its J.POD® biologics… Read more here.
29 July 2025 | US | Celltrion Preferred Bidder for US Biologics Manufacturing Plant
On 29 July 2025, in a report to its shareholders, Celltrion announced that it has been designated as the preferred bidder for an undisclosed large-scale cGMP US manufacturing plant owned by a global… 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
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
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
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.