Biocon Gets FDA Observations At Key Biosimilars Facilities
US Agency Finds Multiple Form 483 Deficiencies Across Bengaluru And Malaysia Sites
Biocon has revealed that an FDA inspection of key biosimilars manufacturing facilities in Bengaluru and Malaysia in August has resulted in numerous Form 483 observations across three Biocon Biologics sites.
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Keeping Track: Travere’s Filspari, Chiesi’s Lamzede, Apellis’ Syfovre Headline US FDA Approvals; CRLs For Phathom, Biocon
The latest drug development news and highlights from the Pink Sheet’s US FDA Performance Tracker.
Viatris remains committed to completing the sale of its global biosimilars unit to Biocon Biologics, while continuing efforts to generate up to $9bn in pre-tax proceeds by the end of 2023 from divestments.
Biocon may not be able to make it to the current contracting cycle in the US for its Viatris-partnered biosimilar aspart, but all is not lost, the management indicates. The Indian firm is also buoyant about the prospects of taking its franchise of potentially interchangeable recombinant human insulin to the US.