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

September 21, 2021 Auto Bot approval, Biogen, Biosimilar, Biosimilars, FDA, ranibizumab, regulatory, Samsung Bioepis 0

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

Click here to­ read full press release/ article | Ref: Globe Newswire | Image: Businesswire

The post Samsung Bioepis and Biogen’s Byooviz (biosimilar, ranibizumab) Receives the US FDA’s Approval for the Treatment of Retinal Vascular Disorders first appeared on PharmaShots.