On 12 December 2025, the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) announced the outcomes of its December 2025 meeting, including positive opinions for two biosimilars.
Bio-Thera/STADA’s Gotenfia® (BAT2506), biosimilar to Janssen’s Simponi® (golimumab), was recommended for the treatment of rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, axial spondyloarthritis and ulcerative colitis.
Gotenfia®/BAT2506 was developed by Bio-Thera and is being commercialised by STADA in Europe under a May 2024 agreement. Alvotech/Advanz’s Gobivaz® was the first golimumab biosimilar approved in Europe last month (November 2025).
A positive CHMP opinion was also adopted for Lupin’s Ranluspec®, biosimilar to Genentech’s Lucentis® (ranibizumab), 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.
Under an August 2025 agreement, Lupin has partnered with Sandoz, which will market and commercialise Lupin’s ranibizumab biosimilar across the European Union (excluding Germany), Switzerland, Norway, Canada, Australia, Hong Kong, Vietnam and Malaysia.
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).