The U.S. Food and Drug Administration (FDA) has approved Celltrion’s OMLYCLO (omalizumab-igec) as the first and only biosimilar designated as interchangeable with XOLAIR (omalizumab) 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).

“We are proud to achieve the approval of the first biosimilar to omalizumab in the U.S., which will help broaden access to this important medicine for patients with allergic and respiratory conditions, as well as for physicians, payers and providers,” said Hetal Patel, Vice President of Medical Affairs at Celltrion USA. “The interchangeability designation of OMLYCLO reinforces confidence among physicians and patients that there is no decrease in effectiveness or increase in safety risk associated with switching between OMLYCLO and the reference product.”

The FDA approval and designation of interchangeability are based on comprehensive clinical evidence, including results from a global Phase III clinical trial involving 619 adult patients with CSU up to Week 40. The result demonstrated the comparable efficacy and safety of OMLYCLO to reference product during both treatment and off-dose periods.

Other Celltrion Biosimilars Approved by the FDA

In January, the FDA approved Celltrion’s AVTOZMA (CT-P47, tocilizumab-anoh) in both an intravenous (IV) and subcutaneous (SC) formulation as a biosimilar to ACTEMRA.

Also, the FDA recently approved Celltrion’s Stoboclo (CT-P41, denosumab-bmwo) and Osenvelt (CT-P41, denosumab-bmwo) as biosimilars to Prolia (denosumab) and Xgeva (denosumab).