Shots: EMA accepted the review of MAA for SB11 in Oct 2020. If approved, SB11 will add to the biosimilars portfolio developed by Samsung Bioepis and commercialized by Biogen, including […]readmore
Tags : Lucentis
Shots: The US FDA has accepted for review the BLA of SB11, a proposed biosimilar referencing Lucentis (ranibizumab) The EMA has accepted for review the MAA of SB11 in Oct’2020. […]readmore
Shots: The P-III study involves assessing SB11 vs reference ranibizumab in monthly injections (0.5 mg) in 705 patients in a ratio (1:1) with nAMD while only 634 patients continued to […]readmore
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 […]readmore
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 […]readmore
Shots: Bioeq to receive up front, regulatory and launch milestones with equal profit sharing. Coherus to get exclusive rights to commercialize biosimilar candidate referencing Genentech’s Lucentis with its anticipated launch […]readmore
Shots: The EMA’s CHMP has recommended the approval of Lucentis (ranibizumab, 10 mg/ml) for the treatment of ROP in preterm infants with EC’s anticipated decision within three months The submission […]readmore
Shots: The in-vivo study was evaluated on group of rabbits administering bilateral intravitreal injection of Xlucane (ranibisumab, Lucentis biosimilar) vs Lucentis divided in two equal groups, testing its PK and […]readmore