Samsung's Byooviz receives EMA approval

September 1, 20210

BYOOVIZ™, a Lucentis biosimilar (ranibizumab), also known as SB1, received Marketing Authorization from European Medicines Agency (EMA) for the treatment of neovascular (wet) age-related macular degeneration (AMD), visual impairment due to diabetic macular edema proliferative diabetic retinopathy, visual impairment due to macular edema secondary to retinal vein occlusion (branch RVO or central RVO) and visual impairment due to choroidal neovascularization in the European Union. Ranibizumab is an anti-vascular endothelial growth factor (VEGF) for retinal vascular disorders, a leading cause of blindness.  

Lucentis’ was first approved in Europe in 2007 for wet AMD. While its USA patent expired last year and in 2020, the U.S. Food and Drug Administration accepted the Biologics License Application for Byooviz and are still awaiting for its approval. Lucentis’ main patents are not due to expire in Europe until next year, however, Samsung Bioepis and Biogen will now roll out the drug as soon the intellectual property on the drug lapses. The product would be a 10-mg/mL injectable solution. 

The approval marks Lucentis’ first biosimilar in Europe. The approval is based on a positive opinion by the Committee for Medicinal Products for Human Use (CHMP) in the month of June which was based on its Phase 3 clinical study, demonstrating equivalence in efficacy for both primary endpoints and showed equivalence to Lucentis in best corrected visual acuity. The treatment differences between groups were stated to be within the predefined equivalence margins for mean changes from baseline in both the standards, best corrected visual acuity (BCVA) and in central subfield thickness (CST). The primary efficacy outcomes’ improvement remained stable and appeared to be comparable between treatment groups at all points up until week 52.  

Samsung Bioepis and Biogen currently have three other anti-TNF biosimilars BENEPALI, IMRALDI and FLIXABI that are approved in Europe and are commercialized in partnership with Biogen. In November 2019, Samsung Bioepis and Biogen entered into a commercialization agreement for two ophthalmology biosimilar candidates, BYOOVIZ (ranibizumab) and SB15 (aflibercept), in the U.S., Canada, Europe, Japan and Australia. While Novartis indicated to have garnered about USD 1.9 billion through sales of Lucentis, Samsung and Biogen are anticipated to erode a large share of this market with the approval of Byoovis. 

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