Tags : Lucentis

Biosimilars

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

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 […]Read More

Biosimilars

Samsung Bioepis and Biogen Announce EMA Filing Acceptance of SB11

Shots: EMA has accepted to review the MAA for SB11, a proposed biosimilar referencing Lucentis (ranibizumab). If approved, SB11 will join a growing number of biosimilars developed by Samsung Bioepis and commercialized by Biogen In Nov 2019, Samsung Bioepis announced that it entered into a new commercialization agreement with Biogen for two ophthalmology biosimilar candidates: […]Read More