Shots:

• The positive CHMP opinion is based on a P-III clinical study evaluating Byooviz that demonstrates equivalence in efficacy for both 1EPs with improvements in 1EPs remained stable & appeared comparable b/w treatment groups at all time points @ 52 wks.
• Additionally- if EC grants marketing authorization- Byooviz will be added to the biosimilars portfolio developed by Samsung Bioepis & commercialized by Biogen- that includes 3 anti-TNF biosimilars in the EU i.e Benepali- Imraldi & Flixabi
• In Nov’19- companies have entered into a commercialization agreement for 2 ophthalmology biosimilar candidates- Byooviz (SB11- ranibizumab) & SB15 (aflibercept) in the US- Canada- EU- Japan & Australia

  | Ref: Biogen | Image: Biogen