On 31 March 2026, 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. 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 have now been delayed to April/May 2026.
According to Xbrane, following resubmission of the BLA for its biosimilar to Genentech’s Lucentis®, an FDA 6-month review process is likely, resulting in an expected Biosimilar User Fee Amendment (BsUFA) date in October/November 2026.
The ranibizumab biosimilar is co-developed by Xbrane and STADA pursuant to a 2018 agreement, and is the subject of an exclusive licensing agreement with US biosimilars specialist 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 Formycon/Sandoz’s Cimerli® (August 2022) 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.