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

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

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