Biocon Launches Bosaya and Aukelso (Biosimilar, Prolia & Xgeva) in the US

Shots: Biocon has reported the commercial launch of Bosaya & Aukelso, an interchangeable biosimilar version of Prolia & Xgeva (Denosumab) in the US, following FDA approval in Sep 2025 Bosaya will be available in the 60mg/mL PFS format, while Aukelso will be available as 120mg/1.7 mL (70mg/mL) single-dose vial, both for subcutaneous use Denosumab is a…

ByRidhi Rastogi2 days ago

Biocon Biologics Obtains the US Market Launch Date for Bosaya and Aukelso (Biosimilar, Prolia & Xgeva)

Shots: Biocon Biologics & Amgen have entered into a settlement & license agreement, allowing the US launch of Bosaya (60mg/mL, SC, PFS) & Aukelso (70mg/mL, SC, single-dose vial), provisional interchangeable biosimilars to Prolia & Xgeva (denosumab) by Oct 1, 2025 Clinical data showed both biosimilars matched the reference product in quality, safety & efficacy, plus Bosaya…

ByRidhi RastogiOctober 3, 2025

Biocon Biologics Receives the FDA’s Approval & Provisional Interchangeability Designation for Aukelso and Bosaya (Biosimilars, Xgeva and Prolia)

Shots: The US FDA has approved & granted provisional interchangeability designation to Aukelso (70mg/mL, SC, single-dose vial) & Bosaya (60mg/mL, SC, PFS), biosimilar versions of Amgen’s Xgeva & Prolia (denosumab) Clinical data showed both biosimilars matched the reference product in quality, safety & efficacy, plus Bosaya was approved with Prolia’s REMS to inform about sev. hypocalcemia…

ByRidhi RastogiSeptember 18, 2025

Biocon Launches Bosaya and Aukelso (Biosimilar, Prolia & Xgeva) in the US

Biocon Biologics Obtains the US Market Launch Date for Bosaya and Aukelso (Biosimilar, Prolia & Xgeva)

Biocon Biologics Receives the FDA’s Approval & Provisional Interchangeability Designation for Aukelso and Bosaya (Biosimilars, Xgeva and Prolia)

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