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On 9 October 2025, New Zealand’s Medsafe approved Sandoz’s Afqlir®, biosimilar to Regeneron/Bayer’s Eylea® (aflibercept 2mg), in vial and pre-filled syringe presentations, making Afqlir® the first aflibercept biosimilar approved in New Zealand.

Sandoz’s aflibercept b...

On 9 October 2025, The Hague District Court published its decision in legal proceedings between Samsung Bioepis and Regeneron in relation to Regeneron’s Dutch equivalents of European patents EP 2 364 691 and EP 1 183 353, covering formulations of aflibercept.  The Court fou...

On 8 October 2025, judgment was published in patent infringement proceedings brought by Regeneron/Bayer in the UK seeking to prevent Samsung Bioepis and Formycon/Klinge from launching biosimilars to Regeneron/Bayer’s Eylea® (aflibercept) in the UK after the November 2025 ex...

Between 18 and 23 September 2025, the US Patent Trial and Appeal Board (PTAB) issued final decisions invalidating Johns Hopkins University’s 11,339,219 (IPR2024-00625), 11,649,287 (IPR2024-00647), 11,629,187 (IPR2024-00649) and 11,634,491 (IPR2024-00650) in four inter parte...

On 7 October 2025, Johnson & Johnson announced that the FDA has approved Simponi® (golimumab) for treating children living with moderately to severely active ulcerative colitis (UC), weighing at least 15 kg.  The FDA approval follows J&J’s submission of the sBLA for...

On 6 October 2025, Alfresa Holdings announced that it has entered into agreements with two other Japanese companies, Kidswell Bio Corporation and Chiome Bioscience Inc., to jointly develop biosimilars for unnamed specified products in Japan.

The agreement follows the...

On 6 October 2025, Alvotech announced that the European Medicines Agency (EMA) has accepted its marketing authorisation application (MAA) for AVT23, biosimilar to Genentech/Novartis’ Xolair® (omalizumab).

AVT23 (also known as ADL-018) was developed by Alvotech in col...

On 6 October 2025, Hikma Pharmaceuticals and Celltrion Inc, announced that they have entered exclusive licensing agreements for 6 biosimilars, across the Middle East and North Africa (MENA) region.  The identities of the biosimilars have not yet been disclosed but they are ...