Biocon, Mylan get USFDA nod for pegfilgrastim from new Bengaluru facility

"Biocon and Mylan's supplemental biologics licence application (sBLA) for pegfilgrastim drug substance to be manufactured in Biocon's new Biologics manufacturing facility has been approved by the US Food and Drug Administration (USFDA)," the company said in a filing to BSE.

New Delhi: Biotechnology major Biocon on Wednesday said that US health regulator has approved its and Mylan's supplemental biologics licence application for a drug substance to be manufactured at its new facility in Bengaluru.

"Biocon and Mylan's supplemental biologics licence application (sBLA) for pegfilgrastim drug substance to be manufactured in Biocon's new Biologics manufacturing facility has been approved by the US Food and Drug Administration (USFDA)," the company said in a filing to BSE.

This additional approval of its new manufacturing facility for pegfilgrastim in Bengaluru will enable the biotechnology major to enable its arm Biocon Biologics and Mylan to scale up capacity multi-fold and address the growing market opportunities in US and other global markets, the company said.

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Biocon Biologics CEO Christiane Hamacher said, "This approval will help us better meet global patient needs for Fulphila, a high-quality biosimilar pegfilgrastim co-developed with Mylan and manufactured by Biocon Biologics".

Biocon Biologics, through its partner Mylan, has commercialised three of its co-developed biosimilars in developed markets like the US, Canada, the European Union and Australia.

The USFDA had conducted a pre-approval inspection of this new drug substance manufacturing facility from September 10-19, 2019.

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