Celltrion Announces U.S. FDA Approval for OMLYCLO®, a First-of-Its-Kind Treatment
Celltrion has announced that the U.S. Food and Drug Administration (FDA) has approved OMLYCLO® (omalizumab-igec) as the first and only biosimilar interchangeable with XOLAIR® (omalizumab).
The biosimilar is indicated for the treatment of moderate to severe persistent asthma, chronic rhinosinusitis with nasal polyps (CRSwNP), Immunoglobulin E (IgE)-mediated food allergy, and chronic spontaneous urticaria (CSU).
The approval is based on extensive clinical research, including a global Phase III clinical trial involving 619 adult patients with CSU over 40 weeks. Participants received either 300 mg or 150 mg of OMLYCLO or the reference product every four weeks.
After 12 weeks, those receiving OMLYCLO continued the treatment, while some patients on 300 mg of the reference product were reassigned to either switch to OMLYCLO or continue with the original treatment. Follow-up assessments were conducted up to Week 40 without further dosing. The results confirmed that OMLYCLO demonstrated similar efficacy and safety compared to the reference product during both the treatment and off-dose periods.
Interchangeable biosimilars meet additional regulatory requirements that allow them to be substituted for the reference product without concerns about reduced effectiveness or increased safety risks. This approval is expected to improve access to omalizumab treatment for patients, healthcare providers, and payers while potentially reducing overall healthcare costs.
Celltrion aims to support patients with allergic conditions in the U.S. through its integrated approach to development, manufacturing, and commercialisation. The company remains committed to ensuring affordable and high-quality treatment options for those who need them.
