Key Points
Omlyclo biosimilar receives interchangeability status
Targets moderate to severe persistent asthma
Global Xolair market valued at $4.1 billion
Celltrion aims to commercialize 22 biosimilars by 2030
The US Food and Drug Administration (FDA) approved Celltrion's Omlyclo, a biosimilar drug to Xolair, for the treatment of moderate to severe persistent asthma, chronic rhinosinusitis with nasal polyps (CRSwNP), according to Celltrion.
The drug can also be used to treat immunoglobulin E (IgE)-mediated food allergy and chronic spontaneous urticaria (CSU), Yonhap news agency reported.
The biosimilar was also granted interchangeability status, enabling it to be substituted for the reference product without intervention by the prescribing healthcare provider, the company added.
The global market for Xolair was estimated to have reached 6 trillion won ($4.1 billion), including 3.7 trillion won in the US, as of 2024.
Celltrion has been making efforts to expand its presence in the US biosimilar market. In recent months, the Korean drugmaker has obtained approval from the FDA for the US sale of several biosimilars, including Avtozma, an autoimmune disease biosimilar to Actemra, Stoboclo and Osenvelt, biosimilar drugs to Prolia and Xgeva.
In January, Celltrion received the US FDA approval for Avtozma for the treatment of autoimmune diseases.
The FDA approved Celltrion's Avtozma in both intravenous and subcutaneous formulations. Avtozma can be used as a treatment for multiple autoimmune diseases, including rheumatoid arthritis and giant cell arteritis, as well as Covid-19.
Avtozma was also approved in Europe by the European Commission (EC) in February, Yonhap reported.
The Korean drugmaker aims to commercialise 22 biosimilar products by 2030, up from the current 11.
Celltrion had said Avtozma has great sales potential, noting its original drug, Actemra, raised 2.63 billion Swiss francs ($2.89 billion) globally in 2023.
