On 27 October 2026, STADA and Xbrane Biopharma (Xbrane) announced that the FDA has approved Lucamzi™ (ranibizumab-blrz), biosimilar to Genentech’s Lucentis®, for the treatment of neovascular (wet) age-related macular degeneration and other serious eye conditions.
The approval follows Xbrane’s announcement on 3 June 2026 that the FDA had accepted its biosimilar ranibizumab BLA, which was given a Biosimilar User Fee Act (BsUFA) action date of 29 October 2026. The ranibizumab biosimilar was co-developed by Xbrane and STADA under a 2018 agreement, and is the subject of an exclusive licensing agreement with Valorum Biologics, which will be responsible for commercialising Lucamzi™ in the US.
Xbrane resubmitted its BLA in April 2026 following an FDA Complete Response Letter (CRL) received in October 2025. This was the second CRL issued in relation to Xbrane’s ranibizumab BLA following 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.
A number of other ranibizumab biosimilars are approved in the US including Samsung Bioepis’ Byooviz® (September 2021, relaunched July 2026), Sandoz’s Cimerli® (August 2022, rights acquired by Sandoz from Coherus in March 2024), Formycon’s Nufymco® (December 2025) and Lupin’s Ranluspec® (June 2026).
Xbrane’s ranibizumab biosimilar has been approved in the EU and UK since November 2022, under the name Ximluci®, and was launched in the EU in April 2023.