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Biocon Malaysia Facility Clearance Could Pave Way For US Biosimilar Approvals

Bevacizumab And Insulin Aspart Filings Had Been Held Up By FDA

 
• By Dave Wallace

Biocon Biologics has announced a change in regulatory status for a manufacturing plant in Malaysia that could pave the way for a pair of long-awaited FDA biosimilar approvals, after similar positive news for an Indian site late last year.

Biocon will be hoping for a clear path to approval (Shutterstock)

Biocon Biologics could be set to finally advance a couple of long-pending US biosimilar filings to the approval stage, after the US Food and Drug Administration upgraded its classification of one of the Indian biosimilars giant’s key manufacturing plants in Malaysia.

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