Samsung Bioepis and Biogen’s Byooviz (biosimilar, ranibizumab) Receives the US FDA’s Approval for the Treatment of Retinal Vascular Disorders

Shots:

• The approval is based on a totality of evidence including analytical, non-clinical/clinical data from the P-III study evaluates the efficacy, safety, PK & immunogenicity of SB11 (0.5mg) vs Lucentis in a ratio (1:1) in 705 patients with wet AMD
• The results showed LS mean change in BCVA from baseline @52wks. (9.79 vs 10.41 letters) & LS mean change in CST (−139.55 vs −124.46 μm) while PK, safety including the incidence of TEAEs & immunogenicity profile were comparable at all timepoints @52wks.
• Byooviz marks the 1st ophthalmology biosimilar approved in the US. In Nov’19, Samsung Bioepis & Biogen had entered into a commercialization agreement for 2 ophthalmology biosimilar i.e., SB11 & SB15

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