Biocon clears US path for denosumab biosimilars

6 October 2025

India-based Biocon’s (BSE: 532523) biosimilars subsidiary has reached a settlement and license agreement with Amgen (Nasdaq: AMGN) that clears the path for the commercialization of Bosaya (denosumab-kyqq) and Aukelso (denosumab-kyqq) in the USA.

Bosaya 60mg/mL injection in a single-dose prefilled syringe (PFS) and Aukelso 120mg/1.7 mL (70mg/mL injection for subcutaneous use in a single-dose vial, are biosimilars to Amgen’s Prolia and Xgeva, respectively. These products are used in the treatment of osteoporosis and cancer-related bone conditions.

Biocon Biologics and Amgen executed the settlement agreement to resolve the pending patent litigation at the US District Court for the District of New Jersey.

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