On 21 October 2025, Xbrane announced that the FDA has issued a Complete Response Letter (CRL) regarding its biosimilar ranibizumab, referencing Genentech’s Lucentis®. The CRL follows the December 2024 resubmission of the BLA after the FDA issued a first CRL in April 2024 identifying issues relating to (a) the analytical methods for the reference standard; and (b) pre-approval inspections of manufacturing partner’s sites.
According to Xbrane, the “FDA conducted re-inspections during Q3 2025 of both production sites involved in production of drug substance and drug product respectively. Thorough evidence on corrective actions to the respective observations was submitted by both production sites in due time to the FDA.” However, in the latest CRL, the FDA refers to unresolved observations following the inspection at one of the production sites without further specification, with no other issues related to the BLA mentioned.
In the October announcement, Xbrane also says that it and its contract manufacturers “are now awaiting further communication from FDA” and will work with the production site to resolve the issues and allow re-submission of the BLA as soon as possible.
The 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, who will be responsible for commercialisation in the US under the Lucamzi™ brand.
There are currently two ranibizumab biosimilars approved in the US. The first approved was Samsung Bioepis’ Byooviz® (September 2021), which was followed by Formycon/Sandoz’s Cimerli® (August 2022).