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

Executive Summary

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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Biocon’s facility in Bangalore, India, has failed to pass muster with the US FDA, raising questions on whether this could result in a pushback of commercialization timelines for partner Mylan’s biosimilar pegfilgrastim in the US. The European regulator has also not cleared the Bangalore site. 

GMP Lapses At Biocon’s Indian Site – Jitters for Neulasta Biosimilar Plans?

Biocon’s facility in Bangalore, India, has failed to pass muster with the US FDA, raising questions on whether this could result in a pushback of commercialization timelines for partner Mylan’s biosimilar pegfilgrastim in the US. The European regulator has also not cleared the Bangalore site. 

FDA Inspection Yields Insight Into Biocon/Mylan Biosimilars Manufacturing Challenges

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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