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Celltrion biosimilars recommended for EU approval

Published: 16 Dec. 2024, 18:24 Updated: 16 Dec. 2024, 18:27

LEE JAE-LIM
[email protected]

Logo of Celltrion [CELLTRION]

Celltrion received recommendations of approval from the European drug regulator for four of its biosimilar products, the Korean pharmaceutical said on Monday.

The candidates are Eydenzelt, Stoboclo, Osenvelt and Avtozma, which the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) recommended for market authorization within the EU member states.

Eydenzelt references Eylea to treat multiple retinal disorders; Stoboclo and Osenvelt, biosimilars of Prolia and Xgeva, are used for the prevention of bone complications in cancer patients and the treatment of osteoporosis; Avtozma references RoActermra to treat autoimmune diseases such as rheumatoid arthritis and giant cell arteritis.

The CHMP’s recommendations will be referred to the European Commission, which will decide whether to grant final approval for the four biosimilars.

“With CHMP approvals, Celltrion solidifies its leadership in the European biosimilar market, offering one of the most extensive antibody biosimilar portfolios,” said Celltrion Vice President Ha Tae-hun, who is in charge of Europe. “Our vertically integrated model ensures supply chain stability while addressing the specific challenges faced by European healthcare professionals and patients. These approvals underscore our commitment to supporting European healthcare systems by improving access to high-quality, affordable treatments.”

BY LEE JAE-LIM [[email protected]]