Formycon and Bioeq Report the US FDA’s Acceptance of BLA for FYB201 (biosimilar, ranibizumab)

 Formycon and Bioeq Report the US FDA’s Acceptance of BLA for FYB201 (biosimilar, ranibizumab)

Shots:

  • The US FDA has accepted the BLA for FYB201, a biosimilar referencing Lucentis for review and assigned a target action date for the application for Aug’2022
  • Following the approval, Coherus will commercialize FYB201 in the US whereas Formycon will participate economically in US sales through its interest in royalties paid by Coherus to Bioeq
  • Lucentis is used in the treatment of neovascular (wet) macular degeneration and acts by inhibiting VEGF, which is responsible for the excessive formation of blood vessels in the retina

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