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US FDA Approves Biocon’s sBLA For Pegfilgrastim New Manufacturing Facility

With the approval of this additional facility, Biocon Biologics and Mylan will be able to address the growing needs of patients for biosimilar Pegfilgrastim in the US

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Biocon announced today that Biocon and Mylan’s supplemental Biologics License Application (sBLA) for Pegfilgrastim  Drug Substance to be manufactured at Biocon’s new Biologics manufacturing facility has been approved by the US Food and Drug Administration (FDA).

With the approval of this additional facility, Biocon Biologics and Mylan will be able to address the growing needs of patients for biosimilar Pegfilgrastim in the US where introduction of the biosimilar has expanded the overall market, increasing access for patients in the US, as well as in other global markets. Fulphila is also approved in other developed markets of EU, Australia and Canada.

This additional approval of its new manufacturing facility for Pegfilgrastim in Bengaluru will enable Biocon Biologics, a subsidiary of Biocon Ltd, and Mylan to scale up capacity multi-fold and address the growing market opportunities in the US and other global markets. The US FDA had conducted a Pre-Approval Inspection of this new Drug Substance manufacturing facility from Sep 10 to Sep 19, 2019. 

Dr. Christiane Hamacher, CEO, Biocon Biologics, 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. 

“Continued penetration of biosimilars will enable higher cost savings for the US healthcare system leading to expansion of patient access to high quality affordable biologics. We are committed to use our science, scale and expertise to shift the access paradigm for patients in need of biosimilars like Pegfilgrastim across the globe,” she added.

Biocon Biologics, through its partner Mylan, has commercialized three of its co-developed biosimilars in developed markets like US, Canada, EU and Australia.  

Fulphila, a biosimilar Pegfilgrastim co-developed by Biocon and Mylan, was the first biosimilar Pegfilgrastim to be approved in the US and was commercially launched in July 2018. It was one of the most successful biosimilar launches in the US.

Biocon Biologics, which houses Biocon’s biosimilars business, is committed to serve the needs of patients, people and partners by providing innovative affordable healthcare solutions going beyond the product. It aims to impact 2.6 million patient lives in FY 20 and aspires to position the company as a global leader.


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