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Biocon Report the US FDA's Approval of sBLA for Fulphila (biosimilar- pegfilgrastim) Manufactured at its New Facility in Bengaluru

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Biocon Report the US FDA's Approval of sBLA for Fulphila (biosimilar- pegfilgrastim) Manufactured at its New Facility in Bengaluru

Shots:

  • The approval of the new manufacturing facility for Fulphila (biosimilar- pegfilgrastim) allows Biocon and Mylan to expand their scale-up capacity- enabling greater patients to access globally. The US FDA had conducted a pre-approval inspection of the new manufacturing facility from Sep 10-19- 2019
  • Biocon is investing in building global-scale- cost-competitive- complex manufacturing facilities addressing the global market opportunities. The approval will meet patient needs for Fulphila across the globe
  • Fulphila is a biosimilar referencing Neulasta- co-developed by Biocon and Mylan and is an approved therapy reduce the duration of febrile neutropenia in multiple countries including the US- EU- Australia and Canada

Click here to­ read full press release/ article | Ref: Biocon | Image: Livemint


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