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

  | Ref: Globe Newswire | Image: Biogen