At its July 2024 meeting, the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) adopted positive opinions for six biosimilars.
Three are biosimilars to Janssen’s Stelara® (ustekinumab): Samsung Bioepis’ Eksunbi, Formycon’s Fymskina (FYB202) and Fresenius Kabi’s Otulfi (FYB202). All are indicated for plaque psoriasis (adult and paediatric), psoriatic arthritis and Crohn’s disease, with Eksunbi and Fymskina additionally indicated for ulcerative colitis.
These CHMP positive opinions follow earlier EU approvals with Alvotech/Stada’s Uzpruvo® approved in January 2024, Samsung Bioepis’ Pyzchiva® in April 2024, and Amgen’s WezenlaTM in June 2024. On 1 July 2024, CHMP also recommended marketing authorisation for Celltrion’s Steqeyma® (CT-P47, ustekinumab). Bio-Thera is behind the race on this molecule, announcing on 24 July 2024 that its MAA for BAT2206 (ustekinumab) was EMA accepted.
Positive CHMP opinions were also adopted at the July 2024 meeting for Dr Reddy’s Ituxredi™, biosimilar to Genentech/Biogen’s Rituxan® (rituximab), Midas Pharma’s Ranibizumab Midas, biosimilar to Genentech’s Lucentis® (ranibizumab) and Prestige Biopharma’s Tuznue®, biosimilar to Roche’s Herceptin® (trastuzumab).
In addition, CHMP adopted positive opinions for two innovator biologics, extended indications for five and issued a negative opinion for one, as reported here.