At its December 2024 meeting, the European Medicine Agency’s Committee for Medicinal Products for Human Use (CHMP) adopted positive opinions for six biosimilars.
Four of these are Celltrion biosimilars: Eydenzelt®/CT-P42 (aflibercept), biosimilar to Regeneron/Bayer’s Eylea®; Osenvelt®/CT-P41 (denosumab), biosimilar to Amgen’s Xgeva®; Stoboclo®/CT-P41 (denosumab), biosimilar to Amgen’s Prolia®; and Avtozma®/CT-P47 (tocilizumab), biosimilar to Roche’s Actemra®.
Biocon’s Yesintek® (ustekinumab), biosimilar to J&J’s Stelara® and CuraTeQ’s Zefylti® (filgrastim), biosimilar to Amgen’s Neupogen® were also given the green light by CHMP at its December 2024 meeting.
Eydenzelt® follows three aflibercept biosimilars already approved in the EU: Biocon’s Yesafili® (September 2023), Sandoz’s Afqlir® (November 2024) and Samsung Bioepis/Biogen’s Opuviz™ (SB15) (November 2024). Formycon/Klinge’s FYB203/Baiama®/Ahzantive® received a CHMP positive opinion in November 2024. Alvotech/Advanz Pharma and Altos Biologics have submitted MAA’s to the EMA for aflibercept biosimilars.
Sandoz’s Jubbonti® and Wyost® were the first denosumab biosimilars to be approved in Europe in May 2024. The EMA has accepted MAAs for denosumab biosimilars including for STADA/Alvotech (AVT03, October 2024), Teva (TVB-009P, October 2024), Gedeon Richter (July 2024), Fresenius Kabi (FKS518, July 2024), and Shanghai Henlius Biotech/Organon (HLX14, May 2024). In November 2024, CHMP adopted positive opinions for Samsung Bioepis’ Obodence™ and Xbryk™ (SB16).
The first tocilizumab biosimilar launched in Europe was Fresenius Kabi’s Tyenne®, in both IV and SC forms, in November 2023. This was followed by the EU-approval of Biogen’s IV tocilizumab, Tofidence™, in June 2024.
Three ustekinumab biosimilars were launched during 2024, STADA/Alvotech’s Uzprovo® and Sandoz’s Pyzchiva® in July 2024, and Celltrion’s SteQeyma® in November 2024. Previously approved ustekinumab biosimilars in Europe include Formycon/Fresenius’ Otulfi®/FYB202 (September 2024), Samsung Bioepis’ Eksunbi™ (September 2024) and Amgen’s Wezenla™ (June 2024). Bio-Thera’s MAA for BAT2206 (ustekinumab) was also accepted by the EMA in July 2024.