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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...

On 8 April 2025, The Bio reported that Dong-A ST has launched Imuldosa®, biosimilar to J&J’s Stelara® (ustekinumab) in the UK and Ireland, following its launch in Germany in January 2025.

Imuldosa® (previously known as DMB-3115) was developed jointly by Dong-A So...

Samsung Bioepis has successfully defeated Janssen Biotech’s appeal in the Hague Court of Appeal in which Janssen sought to overturn an earlier ruling that Samsung Bioepis did not infringe Janssen’s Supplementary Protection Certificates (SPC) by manufacturing and stockpiling...