On 23 December 2025, Formycon and Bioeq (a joint venture between Formycon and Polpharma Biologics) jointly announced that the FDA approved Nufymco® as an interchangeable biosimilar to Genentech’s Lucentis® (ranibizumab).
Nufymco® is the third interchangeable ranibizumab biosimilar approved in the US, following Samsung Bioepis’ Byooviz® (September 2021) and Bioeq/Sandoz’s Cimerli® (August 2022, commercialisation of which has been paused).
Bioeq has further announced that it has entered into a strategic partnership agreement with Zydus Lifesciences in relation to commercialisation of Nufymco® in the US. Under the terms of the strategic partnership, Bioeq is responsible for the development, manufacturing, registration and supply of the finished product, with Zydus responsible for US commercialisation.
Xbrane is also pursuing approval of a ranibizumab biosimilar. In November 2025, Xbrane provided an update on the resubmission of its ranibizumab biosimilar BLA to the FDA following a Complete Response Letter (CRL) received in October 2025. Xbrane expects to be able to resubmit its BLA in March 2026 following completion of corrective action to be taken at the production site of Xbrane’s relevant contract manufacturer.