Biocon, Mylan Get U.S. FDA Nod For Pegfilgrastim Drug Substance Licence
An employee in protective clothing arranges samples inside the research and development center at the Biocon Ltd. campus in Bengaluru, India (Photographer: Dhiraj Singh/Bloomberg)

Biocon, Mylan Get U.S. FDA Nod For Pegfilgrastim Drug Substance Licence

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The United States Food and Drug Administration has approved Biocon Ltd. and Mylan NV’s supplemental biologics licence application for a drug substance to be manufactured at the Indian drugmaker’s new facility in Bengaluru.

"Biocon and Mylan's supplemental biologics licence application for pegfilgrastim drug substance to be manufactured in Biocon's new Biologics manufacturing facility has been approved by the U.S. FDA," Biocon said in an exchange filing on Wednesday.

This additional approval of its new manufacturing facility for pegfilgrastim in Bengaluru will enable Biocon Biologics and Mylan to scale up capacity multifold and address the growing market opportunities in the U.S. and other global markets, the company 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,” Chief Executive Officer Christiane Hamacher said in the exchange filing.

Biocon Biologics, through its partner Mylan, has commercialised three of co-developed biosimilars in developed markets like the U.S., Canada, the European Union and Australia. The U.S. FDA had conducted pre-approval inspection of this new drug substance manufacturing facility from Sept. 10-19, 2019.

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