This undated file photo shows the sign of South Korea’s pharmaceutical giant Celltrion Inc. (Image courtesy of Yonhap)
SEOUL, March 10 (Korea Bizwire) — Celltrion Inc., a major South Korean biopharmaceutical firm, said Monday its biosimilar for asthma and other chronic allergic diseases has obtained approval for U.S. sales.
The U.S. Food and Drug Administration (FDA) approved Celltrion’s Omlyclo, a biosimilar drug to Xolair, for treatment of moderate to severe persistent asthma, chronic rhinosinusitis with nasal polyps (CRSwNP), immunoglobulin E (IgE)-mediated food allergy and chronic spontaneous urticaria (CSU), according to Celltrion.
The biosimilar was also granted interchangeability status, enabling it to be substituted for the reference product without intervention by the prescribing health care provider, the company added.
The global market for Xolair was estimated to have reached 6 trillion won (US$4.1 billion), including 3.7 trillion won in the United States, as of 2024.
Celltrion has been making efforts to expand its presence in the U.S. biosimilar market.
In recent months, the Korean drugmaker has obtained approval from the FDA for U.S. sale of several biosimilars, including Avtozma, an autoimmune disease biosimilar to Actemra, Stoboclo and Osenvelt, biosimilar drugs to Prolia and Xgeva.
(Yonhap)
