On 23 February 2026, Sandoz announced that the European Commission has approved Ranluspec®, biosimilar to Genentech’s Lucentis® (ranibizumab). Sandoz is currently planning to launch Ranluspec® in the EU in the second half of 2026.
The EU marketing approval follows a positive CHMP opinion in December 2025 for the biosimilar, which is indicated for the treatment of nAMD, visual impairment due to DME, proliferative diabetic retinopathy, visual impairment due to macular oedema secondary to retinal vein occlusion (RVO) and visual impairment due to choroidal neovascularisation.
Ranluspec® was developed, manufactured and registered by Lupin. Under an August 2025 agreement between Lupin and Sandoz, Sandoz is responsible for marketing and commercialising the biosimilar across the European Union (excluding Germany), Switzerland, Norway, Canada, Australia, Hong Kong, Vietnam and Malaysia. Sandoz is commercialising Epruvy® (ranibizumab) in Germany under a separate agreement with Formycon/Bioeq.
Samsung Bioepis’ Byooviz® (ranibizumab) was the first ophthalmology biosimilar approved in Europe in August 2021 (in vial form) and has been commercially available in several European countries since March 2023. On 2 December 2025, Samsung Bioepis announced that the CHMP had adopted a positive opinion for Byooviz® in pre-filled syringe (PFS) form. Other ranibizumab biosimilars previously approved in Europe include Formycon’s Ranivisio® (approved August 2022, being commercialised in the EU by Teva) and STADA/Xbrane’s Ximluci® (approved November 2022).