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

Executive Summary

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. 

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