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On 18 April 2025, Regeneron announced that it received a complete response letter (CRL) from the US FDA regarding the supplemental Biologics Licence Application (sBLA) for Eylea HD® (aflibercept, 8mg injection) with extended dosing intervals (up to every 24 weeks) across al...

On 16 April 2025, EmblemHealth, a US nonprofit health insurer, filed a class action complaint in the US District Court for the District of Massachusetts alleging that AstraZeneca subsidiary, Alexion Pharmaceuticals, has unlawfully delayed the introduction of biosimilar comp...

On 16 April 2025, Shanghai-based CDMO, Chime Biologics, announced that it has entered a strategic cooperation agreement with Polpharma Biologics “to advance the end-to-end development and manufacture” of an undisclosed biosimilar product for the global market.  Under the ag...

On 15 April 2025, Petrovax Pharm announced that it is launching its denosumab biosimilar (Forsedeno®) in the Russian market after the Russian Ministry of Health granted marketing authorisation.  This marks Russia’s first approved denosumab biosimilar to Amgen’s Prolia/Xgeva...

On 15 April 2025, Biocon announced that it has entered a settlement and licence agreement with Regeneron, agreeing to dismiss pending US BPCIA litigation regarding its Eylea® (aflibercept) biosimilar, Yesafili™.  The agreement paves the way for a US launch of Yesafili™ (app...

On 14 April 2025, Sandoz announced that it has filed an antitrust lawsuit against Amgen in the US District Court for the Eastern District of Virginia in relation to etanercept.  Sandoz’s complaint, filed on 11 April, alleges that Amgen has “unlawfully extended and entrenche...

On 14 April, Celltrion announced that it has secured interchangeability designation in the US for its high concentration (100mg/mL) citrate free adalimumab biosimilar, Yuflyma® (adalimumab-aaty).

Celltrion’s high concentration formulation was first approved by the FD...

On 10 April 2025, Aurobindo subsidiary, CuraTeQ Biologics, reported its successful Phase I results for BP16, biosimilar to Amgen’s Prolia® (denosumab).

The Phase I study, which included 204 subjects from Australia and New Zealand, showed that BP16 demonstrated compar...