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

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