On 30 April 2026, Xbrane announced that it has resubmitted its BLA for biosimilar ranibizumab to the FDA following a Complete Response Letter (CRL) received in October 2025. In November 2025, Xbrane had indicated that it expected to resubmit its BLA in March 2026. However, following Xbrane’s contract manufacturer receiving “further detailed feedback from the FDA”, Xbrane’s resubmission plans were delayed.
The biosimilar to Genentech’s Lucentis® is co-developed by Xbrane and STADA pursuant to a 2018 agreement, and is the subject of an exclusive licensing agreement with Valorum Biologics, which will be responsible for commercialisation in the US.
There are currently three ranibizumab biosimilars approved in the US. The first approved was Samsung Bioepis’ Byooviz® (September 2021), followed by Sandoz’s Cimerli® (August 2022, rights acquired by Sandoz from Coherus in March 2024) and Formycon’s Nufymco® (December 2025).
Xbrane’s ranibizumab biosimilar has been approved in the EU and UK since November 2022, under the name Ximluci®. It was launched in the EU in April 2023.