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
Click here to read the full press release
Tuba was Senior Editor at PharmaShots. She was curious, creative, and passionate about recent updates and innovations in the life sciences industry. She covered Biopharma, MedTech, and Digital health segments. Tuba also had an experience in digital and social media marketing and ran the campaigns independently. She can be contacted at connect@pharmashots.com.
