On 20 November 2025, Formycon and Bioeq jointly announced that their commercialisation partner, Sandoz, has launched Epruvy®, biosimilar to Genentech’s Lucentis®, in Germany. Sandoz is marketing the product, which is indicated for nAMD, macular oedema, diabetic retinopathy and other visual impairments, under licence from Bioeq, a joint venture between Formycon and Polpharma Biologics.
Epruvy® was approved by the European Medicines Agency in September 2024 (as Ranibizumab Midas), following a positive CHMP opinion in July 2024, and is available in vial and pre-filled syringe (PFS) dosage forms. According to Formycon, the PFS is a “first-of-its kind ophthalmic biosimilar presentation in Germany”.
Formycon/Teva’s Lucentis® biosimilar, FYB201/Ranivisio®, was first approved in Europe in August 2022 and has been commercialised in the region in vial form by Teva since 2022. In October 2025, Formycon/Teva announced the launch of the PFS form in France, with additional countries to follow in a staggered approach. FYB201 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 in Europe include Samsung Bioepis’ Byooviz® (EU-approved in September 2021); Lupin’s biosimilar (being marketed in the EU by Sandoz); and STADA/Xbrane’s Ximluci® (EU-approved 9 November 2022).