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On 26 September 2025, Amneal Pharmaceuticals announced that it submitted a Biologics License Application (BLA) to the US FDA for ADL-018 (omalizumab), biosimilar to Novartis’ Xolair®.

ADL-018 was developed by Kashiv Biosciences, with Amneal holding exclusive US comme...

On 25 September 2025, the Munich Regional Court granted Regeneron and Bayer a cross-border preliminary injunction (PI) preventing Formycon from launching FYB203, biosimilar to Regeneron/Bayer’s Eylea® (aflibercept).  According to the Juve Patent report, the PI covers 22 Eur...

On 24 September 2025, Medical Dialogues reported that India’s Subject Expert Committee (SEC) of the Central Drugs Standard Control Organisation (CDSCO) has instructed Intas Pharmaceuticals to submit a revised protocol for its proposed biosimilar pembrolizumab Phase I/III cl...

New Zealand’s drug funding agency, Pharmac, has opened for public consultation a provisional agreement with Roche to fund a package of Roche drugs, including subcutaneous formulations of biologics previously only funded as IV treatments.  The agreement includes the followin...

On 24 September 2025, Australia’s Therapeutic Goods Administration (TGA) updated its online list of prescription medicines for evaluation for the months of July, August and September.  Among the additions is Celltrion’s July 2025 application for an indication extension to E...

On 23 September 2025, Bristol Myers Squibb announced that the Institut national d’excellence en santé et en services sociaux (INESSS) has issued a positive recommendation for the reimbursement of Opdivo® SC (nivolumab for subcutaneous injection) in Quebec across Health Cana...

On 23 September 2025, GxP News reported that Russian company, Generium, has obtained registration of the first Russian biosimilar to Novartis’ Ilaris® (canakinumab).  The biosimilar, Limiris™, has been approved as a lyophilised powder for subcutaneous injection and is indic...

On 23 September 2025, Korea Biomedical Review reported that Sam Chun Dang’s SCD411, biosimilar to Regeneron/Bayer’s Eylea® (aflibercept), was approved in both Japan and Korea in vial and pre-filled syringe (PFS) forms.

The latest approvals follow SCD411’s Canadian ap...