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Three Years After US Filing, Biocon’s Bevacizumab Remains Out Of Reach

Indian Firm Has Received CRL From FDA, Must Resolve Facility Observations

 
• By Dean Rudge

Following launches in other key developed markets, Biocon’s plans to break into the US bevacizumab market continue to be frustrated, with further bad news from the US Food and Drug Administration.

• Source: Shutterstock

Biocon shelled out billions to take control of the biosimilar joint venture it previously operated with Viatris, but deficiencies observed at several of its key manufacturing facilities continue to hold up US Food and Drug Administration approvals, dwindling further immediate returns on its investment.

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