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On 16 September 2025, STADA announced that Afiveg®, biosimilar to Regeneron/Bayer’s Eylea® (aflibercept) received European Commission approval as 40mg/ml solution for injection in pre-filled syringes and vials.  The approval follows a positive opinion from the EMA’s CHMP in...

On 15 September 2025, Bio-Thera and Saudi Arabia-headquartered Jamjoom Pharmaceuticals Factory Company announced they have entered a strategic commercialisation agreement for BAT2306, biosimilar to Novartis’ Cosentyx® (secukinumab).

Under the agreement, Bio-Thera wil...

On 11 September 2025, Kashiv BioSciences announced that it has entered into a licensing and supply agreement with Brazilian pharmaceutical company, CRISTÁLIA, to bring ADL-018, biosimilar to Novartis’ Xolair® (omalizumab), to the Latin American market.

Under the agre...

On 10 September 2025, the District Court of The Hague delivered judgment in Samsung Bioepis’ revocation action against Janssen’s EP 3 883 606 (the Janssen Patent), ruling that the method of treatment patent is valid.  The Janssen Patent relates to the use of ustekinumab in ...

On 10 September 2025, Celltrion announced that it will present its global Phase 1 clinical trial results for CT-P55, biosimilar to Novartis’ Cosentyx® (secukinumab), at the upcoming 2025 European Academy of Dermatology and Venereology Congress (EADV) to be held 17-20 Septem...

On 10 September 2025, Celltrion confirmed that it is planning the European launch of Omlyclo® (CT-P39), biosimilar to Genentech’s Xolair® (omalizumab), later this year to secure ‘first mover’ advantage.

Omlyclo® is approved in the EU (May 2024), Korea (June 2024), Au...

On 10 September 2025, Regeneron filed a patent infringement suit against Alvotech and Fisher Clinical Services UK Limited in the High Court of Justice for England & Wales.  The details of the allegations are not yet publicly available, but the dispute is reported to rel...