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.
Biocon Malaysia Facility Clearance Could Pave Way For US Biosimilar Approvals
Bevacizumab And Insulin Aspart Filings Had Been Held Up By FDA
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.
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