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FDA Inspection Yields Insight Into Biocon/Mylan Biosimilars Manufacturing Challenges

Executive Summary

Biocon's Bangalore, India, biosimilars manufacturing operation needs quick fix to meet goal dates for pegfilgrastim and trastuzumab in US, even as it works to restore GMP compliance for EU marketing authorization.

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Biocon, Dr Reddy’s Might Be Out Of The Woods On GMP Issue

Two Indian firms – Biocon and Dr Reddy’s – have received crucial establishment inspection reports (EIRs) from the US FDA amid improved compliance levels at their manufacturing sites.

Will FDA GMP Observations Stall Biocon’s Run?

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.

Will GMP Lapses Stall Biocon-Mylan’s Biosimilars Build-Up?

Compliance deviations flagged by French regulator ANSM at Biocon’s Indian site have raised questions around commercialization timelines in the EU for the firm and partner Mylan’s biosimilars, including trastuzumab. The news comes ahead of an FDA advisory panel review later this week for the product. Biocon, though, appears confident of setting compliance woes right quickly.


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