Home > Business > Industry

Celltrion asthma drug Omlyclo approved for U.S. release

Published: 10 Mar. 2025, 14:37

LEE JAE-LIM
[email protected]

Logo of Celltrion [CELLTRION]

Celltrion said on Monday that its biosimilar Omlyclo had received market authorization for U.S. release.

The drug, referencing Xolair, can treat multiple allergic conditions including moderate to severe persistent asthma, chronic rhinosinusitis with nasal polyps, chronic spontaneous urticaria and immunoglobulin E-mediated food allergies. Upon the U.S. Food and Drug Administration's approval, Omlyclo will be freely interchangeable with Xolair at pharmacies without requiring a prescription change.

It has also been approved for use in the European Union and Canada.

“Not only has Omlyclo secured first-mover approval in the U.S., the world’s largest pharmaceutical market, but it has also gained interchangeable status, giving it a strong competitive advantage upon its release,” said Celltrion spokesperson in a statement. “We are committed to ensuring Omlyclo’s successful entry into the U.S. and global markets, driving revenue growth.”

Celltrion added four new biosimilars to its U.S. portfolio in the first quarter this year, including Omlyclo, autoimmune disease treatment Avtozma, osteoporosis treatment Stoboclo and Osenvelt, which helps to prevent bone complications in cancer patients.

BY LEE JAE-LIM [[email protected]]