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
| Ref: Globe Newswire | Image: Biogen
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