OMLYCLO®: First FDA-Approved Interchangeable Biosimilar to XOLAIR® Now Available

Celltrion USA, Inc. has announced the commercial availability of OMLYCLO® (omalizumab-igec), marking a significant milestone as the first and only FDA-approved interchangeable biosimilar to XOLAIR® (omalizumab). This new treatment option is now available in various dosages, including 75 mg/0.5 mL, 150 mg/mL, and 300 mg/2mL, all packaged in single-dose prefilled syringes for subcutaneous injection.

OMLYCLO® is indicated for the treatment of moderate to severe persistent asthma, chronic rhinosinusitis with nasal polyps, IgE-mediated food allergies, and chronic spontaneous urticaria. This approval is expected to enhance treatment options for patients suffering from these allergic and inflammatory conditions.

Dr. Juby Jacob-Nara, Chief Medical Officer at Celltrion USA, emphasized the importance of this launch, stating that it addresses the high costs associated with biologic therapies, which have limited patient access. The introduction of OMLYCLO® aims to improve affordability and expand access to effective treatment options.

The availability of OMLYCLO® is seen as a breakthrough for the allergy and immunology community, providing healthcare providers with the first interchangeable biosimilar option in this therapeutic area. Experts believe that this will significantly benefit patients who have not responded well to standard therapies.

As the healthcare landscape evolves, Celltrion's commitment to developing high-quality biosimilars is expected to play a crucial role in improving patient care and expanding access to essential medications.