Celltrion, Inc. today announced the U.S. Food and Drug Administration (FDA) has approved a new presentation of OMLYCLO® (omalizumab-igec), the first and only biosimilar designated as interchangeable with XOLAIR® (omalizumab), in a 300mg/2mL solution in a single-dose prefilled syringe for subcutaneous injection. In the U.S., OMLYCLO will be marketed and distributed exclusively by Celltrion USA, Inc.
In March 2025, the FDA approved OMLYCLO in 75 mg/0.5 mL and 150 mg/mL solutions in a single-dose prefilled syringe for subcutaneous injection 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 of the additional 300 mg presentation of OMLYCO underscores our dedication to patients in the U.S., by broadening treatment choices and expanding flexibility, addressing diverse needs of patients with allergic and inflammatory conditions," said Dr. Juby Jacob-Nara, Senior Vice President and Chief Medical Officer at Celltrion USA. "The new dosing option of OMLYCLO can help reduce the number of required injections and ease the overall treatment burden and discomfort for patients with these diseases."
"We are proud of the expansion of OMLYCLO's dosing options, marking another significant milestone in our commitment to increasing access to biologic treatments in the U.S.," said Thomas Nusbickel, Chief Commercial Officer at Celltrion USA. "We remain steadfast in our efforts to support physicians with flexible, high-quality treatment options and ensure that more patients can benefit from best-in-class care."
