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Will FDA GMP Observations Stall Biocon’s Run?

 
• By Anju Ghangurde

The FDA has flagged up GMP deviations at Biocon’s Bangalore site, though the company asserts that most of these are procedural blips resulting from ‘heightened’ regulatory expectations. The compliance concerns come ahead of the user fee goal date for Biocon and partner Mylan’s biosimilar trastuzumab next month.

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Biocon Ltd. continues to grapple with GMP challenges – this time an FDA audit has identified 10 deviations at its Bangalore manufacturing site, though the company suggests it is already on course to set things right. The FDA inspection at Biocon’s Bommasandra site in Bangalore was done between May 25 and June 3.

The latest regulatory setback comes in the run up to the anticipated FDA action date for Biocon and partner Mylan NV ’s biosimilar trastuzumab on Sept

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