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 three widely prescribed anti-TNF biosimilars in EU: BENEPALI, IMRALDI, and FLIXABI In Nov 2019, Samsung Bioepis entered into a new commercialization agreement with Biogen for […]Read More
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. If approved, SB11 will add to the biosimilars portfolio developed under the collaboration of Samsung Bioepis and Biogen including Benepali, Imraldi & Flixabi In Nov’2019, […]Read More
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 receive treatment up to 48wks. One-year results from the P-III study demonstrated equivalence between SB11 and reference ranibizumab in patients with nAMD The study met […]Read More
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
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
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 in 2021 in the US Bioeq will be responsible for product delivery to the Coherus and will submit BLA to the US FDA in Q4’19 […]Read More
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 is based on P-III RAINBOW study results demonstrating Lucentis is safe & well tolerated in infants with ROP. Post-EU approval, Lucentis (0.2 mg) will be […]Read More
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 tolerability in both the serum and the eyeglass body The results show Xlucane is well tolerated with no ocular inflammation in eyes, with equivalent PK […]Read More
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