On 2 June 2026, the FDA approved Lupin’s Ranluspec® (ranibiziumab-hkdz) as an interchangeable biosimilar of Genentech’s Lucentis®. Ranluspec® is approved in both vial and pre-filled syringe presentations for the treatment of nAMD, macular oedema following retinal vein occlusion, diabetic macular oedema, diabetic retinopathy, and myopic choroidal neovascularization.
The following day, on 3 June 2026, Xbrane announced that the FDA accepted its biosimilar ranibizumab BLA, which has been given a Biosimilar User Fee Act (BsUFA) action date of 29 October 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 Valorum Biologics, which will be responsible for commercialising the product in the US under the name Lucamzi™.
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.
The first ranibizumab biosimilar approved in the US 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®, and was launched in the EU in April 2023. Lupin’s Ranluspec® was approved in the EU in February 2026, where it is being commercialised by Sandoz under an August 2025 agreement.