Celltrion Secures USFDA Nod for Allergic Asthma Biosimilar
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Synopsis
Celltrion, a prominent South Korean biopharmaceutical company, has received FDA approval for its asthma biosimilar, Omlyclo, effective for chronic allergic diseases. The drug is also interchangeable with the original Xolair, marking a significant milestone in the US market.
Key Takeaways
- Celltrion has received FDA approval for its asthma biosimilar, Omlyclo.
- The drug is indicated for moderate to severe persistent asthma.
- Omlyclo is approved for multiple allergic conditions including IgE-mediated food allergies.
- The biosimilar has received an interchangeability status.
- Celltrion aims to expand its biosimilar portfolio significantly by 2030.
Seoul, March 10 (NationPress) Celltrion, a leading biopharmaceutical company from South Korea, announced on Monday that its biosimilar targeting asthma and other chronic allergic conditions has received approval for distribution in the United States.
The US Food and Drug Administration (FDA) has given the green light to Celltrion's Omlyclo, a biosimilar to Xolair, which is intended for managing moderate to severe persistent asthma, as well as chronic rhinosinusitis with nasal polyps (CRSwNP), as reported by Celltrion.
This medication is also indicated for the treatment of immunoglobulin E (IgE)-mediated food allergies and chronic spontaneous urticaria (CSU), according to the Yonhap news agency.
Furthermore, the biosimilar has received interchangeability status, allowing it to be substituted for the reference product without the need for intervention from the prescribing healthcare provider, the company noted.
The global market for Xolair was projected to reach 6 trillion won ($4.1 billion), with 3.7 trillion won attributed to the US market by 2024.
Celltrion is actively working to boost its footprint in the US biosimilar sector. Recently, the South Korean company has secured FDA approval for several biosimilars, including Avtozma, which targets autoimmune diseases and is a biosimilar to Actemra, among others like Stoboclo and Osenvelt, which are biosimilars to Prolia and Xgeva, respectively.
In January, Celltrion received FDA approval for Avtozma, which is aimed at treating autoimmune diseases.
The FDA approved Avtozma in both intravenous and subcutaneous forms, with applications for a variety of autoimmune diseases, including rheumatoid arthritis and giant cell arteritis, as well as for Covid-19.
Avtozma also received approval from the European Commission (EC) in February, as reported by Yonhap.
The South Korean firm aims to launch 22 biosimilar products by 2030, increasing from its current lineup of 11.
Celltrion believes Avtozma holds significant commercial potential, highlighting that its original counterpart, Actemra, generated 2.63 billion Swiss francs ($2.89 billion) in global sales in 2023.
