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

 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

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

Tuba Khan

Tuba Khan is Senior Editor at PharmaShots. She is curious, creative, and passionate about recent updates and innovation in the Life sciences industry. She covers Biopharma, MedTech, and Digital health segments. Tuba also has an experience of digital and social media marketing and runs the campaigns independently. She can be contacted on tuba@pharmashots.com

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