Polpharma Biologics Reports the US FDA’s Acceptance of BQ201’s (biosimilar, ranibizumab) BLA for Review to Treat Wet Age-Related Macular Degeneration

October 5, 2021 Auto Bot Acceptance, Biosimilar, Biosimilars, BLA, FDA, ranibizumab 0

Shots:

  • The US FDA has issued a notification to Polpharma Biologics for the acceptance of BQ201’s (biosimilar, ranibizumab) BLA to treat wet AMD with an anticipated PDUFA date in Aug’22
  • The launch of biosimilar ranibizumab may increase market competition, reduce cost & expand patient access with proven analytical & clinical similarity to Lucentis
  • Coherus will exclusively commercialize BQ201 in the US, following the FDA’s approval. Bioeq’s proposed ranibizumab biosimilar BQ201 (formerly FYB201) has been originally licensed from Formycon AG

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

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