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Biocon And Mylan Prime Pegfilgrastim Expansion

US FDA Approves Biocon’s sBLA for New Pegfilgrastim Facility

Executive Summary

Biocon-Mylan’s sBLA for pegfilgrastim made at a new Indian site gets an FDA go-ahead, facilitating a "multi-fold" scale up in capacity. But it will be interesting to watch how impactful this could be on market dynamics in the US, where more competition has arrived.

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