At its December 2025 meeting, the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) recommended indication extensions for a number of biopharmaceuticals.
Among these, Regeneron/Bayer’s Eylea® 8mg (aflibercept) 114.3 mg/ml solution for injection) was recommended for the treatment of visual impairment due to macular oedema secondary to retinal vein occlusion (branch, central and hemiretinal RVO). Once approved by the European Commission, this will be the third indication for the high dose form of Eylea®, which was previously approved in the EU in January 2024 for treatment of nAMD and diabetic macular oedema. Eylea HD® (as the 8mg product is known in the US) was FDA approved for the RVO indication in November 2025.
Alvotech is developing AVT29, a biosimilar to Regeneron’s Eylea® 8mg. In June 2024, Alvotech entered into an agreement with Advanz Pharma in relation to the commercialisation of AVT29 in Europe. Teva holds commercialisation rights for AVT29 (and AVT06, aflibercept 2mg) in the US.
This month, the CHMP has also adopted a positive opinion for Janssen’s Simponi® (golimumab), for the treatment of paediatric ulcerative colitis. The CHMP decision follows the FDA’s approval of the same indication in October 2025.
Alvotech/Advanz’s Gobivaz® was the first and only EU golimumab biosimilar approved in Europe in November 2025. However, Bio-Thera/STADA’s Gotenfia®/BAT2506 is following closely behind, with a positive CHMP opinion for the biosimilar adopted at the December 2025 EMA meeting.
Other biopharmaceuticals to receive CHMP recommendations at the December 2025 meeting are:
- GSK’s Nucala® (mepolizumab), for chronic obstructive pulmonary disease (COPD); and
- Amgen’s Uplizna® (inebilizumab), for neuromyelitis optica spectrum disorders (NMOSD).