On 21 October 2025, Formycon and Teva jointly announced the European launch of FYB201/Ranivisio®, biosimilar to Genentech’s Lucentis® (ranibizumab), in pre-filled syringe (PFS) presentation. The product is the first biosimilar ranibizumab to be offered in a PFS presentation in Europe, and will launch first in France this month, with additional countries, including Germany, to follow in a staggered approach.
FYB201/Ranivisio® was first approved in Europe in August 2022, and was developed by Bioeq (a joint venture between Formycon and Polpharma Biologics), and has been commercialised in the region in vial, and now PFS form, by Teva since 2022. It was approved in the UK (in May 2022, marketed as Ongavia® by Teva), the US (in August 2022, marketed as Cimerli®, to which Sandoz acquired the marketing rights from Coherus in March 2024), Canada (in December 2023, marketed as Ranopto™ by Teva) and MENA (in March 2024, marketed as Ravegza® by MS Pharma).
Other approved ranibizumab biosimilars include Samsung Bioepis’ Byooviz® (EU-approved in September 2021, FDA-approved in September 2021); Lupin’s biosimilar (being marketed in the EU by Sandoz); and STADA/Xbrane’s Ximluci® (EU-approved 9 November 2022).