On 20 June 2025, the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) published the outcome of its June meeting, with positive opinions for aflibercept biosimilars of STADA, Polpharma and Advanz Pharma, and Bio-Thera’s biosimilar ustekinumab.
STADA’s Afiveg®, Polpharma’s Eiyzey® and Vgenfli®, and Advanz Pharma’s Mynzepli®, biosimilars to Regeneron/Bayer’s Eylea® (aflibercept), were each recommended (as 40 mg/ml solution for injection in pre-filled syringes and vials) for treatment of nAMD and visual impairment due to macular oedema secondary to retinal vein occlusion/diabetic macular oedema (DME)/myopic choroidal neovascularisation.
There are currently seven aflibercept (2mg) biosimilars approved in Europe: Celltrion’s Eydenzelt® (February 2025), Biocon’s Yesafili® (September 2023), Sandoz’s Afqlir® (November 2024), Samsung Bioepis/Biogen’s Opuviz™ (SB15) (November 2024), Formycon/Klinge’s Baiama® and Ahzantive® (January 2025) and Amgen’s Pavblu® (April 2025). Amgen’s Skojoy® received a positive recommendation for marketing approval from the CHMP in January 2025 but the application was withdrawn in April 2025.
Bio-Thera Solution’s Usympro® (BAT2206), biosimilar to J&J/Janssen’s Stelara® (ustekinumab) also received a positive CHMP opinion, for the treatment of plaque psoriasis, psoriatic arthritis and Crohn’s disease. Bio-Thera and Gedeon Richter entered into a licence and commercialisation agreement for Usympro®/BAT2206 in October 2024, under which Bio-Thera is responsible for the development and manufacturing of the product while Richter has commercialisation rights for the EU, UK and Switzerland. BAT2206 was approved in the US in May 2025 where it is to be commercialised by Hikma Pharmaceuticals under the name Starjemza®.
A sixth biosimilar recommended by the CHMP at its June meeting was Biocon’s Vivlipeg®, biosimilar to Amgen’s Neulasta® (pegfilgrastim), to reduce the duration of neutropenia and the incidence of febrile neutropenia after cytotoxic chemotherapy. The recommendation comes over 6 years after the approval of the first European pegfilgrastim biosimilar, Accord Healthcare’s Pelgraz®, in September 2018.