Pearce IP provides weekly reports on global biosimilars activities in the Pearce IP BioBlast®. Significant biosimilar activities for the last three weeks ending 9 January 2026 are set out below:
Adalimumab
On 31 December 2025, Mabwell announced that it has received marketing approval from the Indonesian Food and Drug Authority for its Adalimumab Injection 9MW0113… Read more here.
On 23 December 2025, Biocon Biologics announced that is has secured full and exclusive global rights for Hulio®, biosimilar to AbbVie’s Humira® (adalimumab), from Fujifilm… Read more here.
Aflibercept
Bevacizumab
On 31 December 2025, Outlook Therapeutics announced that the FDA issued a Complete Response Letter (CRL) regarding the second resubmission of its Biologics Licence… Read more here.
Daratumumab
Denosumab
On 1 January 2026, Medical Dialogues reported that Dr Reddy’s has disclosed to various stock exchanges that it has received a Complete Response Letter (CRL) from the FDA in… Read more here.
On 22 December 2025, Amneal Pharmaceuticals and mAbxience announced that the FDA has approved Boncresa™ and Oziltus™ (MB09), biosimilars to Amgen’s Prolia® and… Read more here.
Guselkumab
On 19 December 2025, Johnson & Johnson announced that the European Commission has approved an indication extension for Tremfya® (guselkumab) as a subcutaneous treatment… Read more here.
Ipilimumab
On 25 December 2025, Innovent announced that its Tabosun® (ipilimumab N01 injection), referencing BMS’ Yervoy®, in combination with Tyvyt® (sintilimab, co-developed by Innovent… Read more here.
Mepolizumab
GSK’s Nucala® (mepolizumab) has received approval in China and the UK as an add-on maintenance treatment for adult patients with inadequately controlled COPD characterised by… Read more here.
Nivolumab, Pembrolizumab, Trastuzumab
On 6 January 2026, Biocon Biologics announced that it will unveil three new biosimilars at the 2026 J.P. Morgan Healthcare Conference to be held 12-16 January 2026 in San Francisco… Read more here.
Omalizumab
On 24 December 2025, Celltrion announced that it has secured approval in Korea for an autoinjector presentation (75mg and 150 mg) of Omlyclo®, biosimilar to Novartis’ Xolair®… Read more here.
Pertuzumab, Cetuximab
On 22 December 2025, R-Pharm announced that it has presented its progress on two biosimilar products at the 29th Russian Oncology Congress: Persinthia®, biosimilar to Roche’s… Read more here.
Ranibizumab
On 23 December 2025, Formycon and Bioeq (a joint venture between Formycon and Polpharma Biologics) jointly announced that the FDA approved Nufymco® as an… Read more here.
Ustekinumab
On 6 January 2026, Fresenius Kabi announced that it has introduced a new presentation of Otulfi®, biosimilar to Janssen’s/J&J’s Stelara® (ustekinumab), in a 45 mg/0.5 mL single-dose… Read more here.
On 27 December 2025, Medical Dialogues reported that Aurobindo Pharma’s wholly-owned subsidiary, CuraTeQ, had terminated its agreement with US-based BioFactura Inc regarding… Read more here.
On 23 December 2025, Samsung Bioepis announced that it has received marketing approval in Japan for Nipro™, biosimilar to J&J’s/Janssen’s Stelara® (ustekinumab). Nipro™ delivers… Read more here.
Vedolizumab
On 8 January 2026, Takeda announced that it has entered a global collaboration and licence agreement with Halozyme Therapeutics, Inc, which grants Takeda exclusive rights… 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.