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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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