Celltrion's Xolair biosimilar nabs US approval for 300mg PFS version

[Lim Jeong-yeo, Edaily Reporter] Celltrion's OMLYCLO, the first and only biosimilar designated as interchangeable with XOLAIR(omalizumab), has received approval from the U.S. Food and Drug Administration(FDA) in a new presentation of 300mg/2mL solution in a single-dose prefilled syringe for subcutaneous injection, the company announced Wednesday. In the U.S., OMLYCLO will be marketed and distributed exclusively by Celltrion USA.

(Cred=Celltrion)

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."

Celltrion's OMLYCLO is the first FDA-approved anti-IgE antibody biosimilar referencing XOLAIR. OMLYCLO 75 mg/0.5 mL, 150 mg/mL and 300 mg/2mL solutions in a single-dose prefilled syringe is approved as interchangeable with the reference product for all indications based on comprehensive data and clinical evidence confirming the therapeutic equivalence to XOLAIR.

OMLYCLO was approved by the FDA and the European Commission(EC) in March 2025 and May 2024, respectively.