Formycon Reports BLA Resubmission Strategy for FYB201 (biosimilar, ranibizumab)

November 6, 2020 Auto Bot Biosimilar, Biosimilars, BLA, Formycon, Lucentis, reports, Strategy 0

Shots:

  • Formycon & Bioeq reported the BLA resubmission strategy for FYB201 (biosimilar referencing Lucentis) has been adjusted
  • With the revised submission strategy, the companies expect a simplification of the approval procedure. The modified submission dossier is anticipated to be filed with the US FDA in H1’21
  • The adjustment of the regulatory strategy while optimizing the commercial supply chain is not expected to have any impact on the timing of the anticipated launch of FYB201 in the US & EU

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

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