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Approval Alert: Bioeq and Teva’s FYB201/Ranopto® (ranibizumab)

Dec 7, 2023

Bioeq and Teva jointly announced that Health Canada granted a Notice of Compliance for Ranopto® (ranibizumab), biosimilar to Genentech’s Lucentis® (ranibizumab).  Ranopto® is indicated for the treatment of neovascular (wet) age-related macular degeneration, the treatment of visual impairment due to diabetic macular oedema or choroidal neovascularization, as well as the treatment of visual impairment due to macular oedema secondary to retinal vein occlusion.

FYB201/Ranopto® was developed by Bioeq (a JV between Formycon and Polpharma Biologics). Teva entered into a strategic partnership for the exclusive commercialisation of FYB201 in Canada, Europe and selected other countries in mid 2021. Following successful approvals in the UK (marketed as Ongavia® by Teva) in May 2022, as well as the US (marketed as Cimerli® by Coherus) and the EU (as Ranivisio®) in August 2022, Ranopto® is expected to launch in Canada in Q1 2024.  MS Pharma will commercialise FYB201 in the Middle East and North Africa (MENA) region following approval by the relevant regulatory authorities.

This is the third ranibizumab biosimilar approved in Canada, after Samsung Bioepis’ Byooviz® was approved in March 2022, and Roche’s Susvimo® was approved in September 2022.