Celltrion Gains FDA Approval for New 300mg OMLYCLO® Biosimilar

Celltrion, Inc. has announced that the U.S. Food and Drug Administration (FDA) has granted approval for a new strength of its biosimilar, OMLYCLO® (omalizumab-igec). This 300mg presentation is the first and only biosimilar designated as interchangeable with XOLAIR® (omalizumab). The approval, confirmed on December 3, 2025, allows for a single-dose prefilled syringe for subcutaneous injection, enhancing treatment options for patients with certain allergic and inflammatory conditions.

OMLYCO® was initially approved by the FDA in March 2025 for 75 mg and 150 mg presentations, which are used to treat moderate to severe persistent asthma, chronic rhinosinusitis with nasal polyps (CRSwNP), Immunoglobulin E (IgE)-mediated food allergies, and chronic spontaneous urticaria (CSU). With the introduction of the 300 mg strength, Celltrion aims to provide more flexibility and convenience for patients, as noted by Dr. Juby Jacob-Nara, Senior Vice President and Chief Medical Officer at Celltrion USA.

Dr. Jacob-Nara stated, “The approval of the additional 300 mg presentation of OMLYCLO 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.” She highlighted that the new dosing option can help reduce the number of required injections, thus alleviating the treatment burden for patients.

Thomas Nusbickel, Chief Commercial Officer at Celltrion USA, expressed pride in the expanded dosing options. “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.,” he said. This development aligns with Celltrion’s ongoing mission to support healthcare providers with reliable and high-quality treatment alternatives.

About OMLYCLO® and Its Applications

OMLYCO® is the first FDA-approved anti-IgE antibody biosimilar referencing XOLAIR®. This new formulation is approved as interchangeable with the reference product for all indications, backed by comprehensive clinical data confirming its therapeutic equivalence. The biosimilar was also approved by the European Commission in May 2024, showcasing Celltrion’s global reach in the biopharmaceutical sector.

The indications for OMLYCLO® include treatment for moderate to severe persistent asthma and CRSwNP, among others. However, there are limitations on its use. The product is not indicated for acute bronchospasm or status asthmaticus and should not be relied upon for emergency treatment of allergic reactions, including anaphylaxis.

Safety Information and Considerations

Celltrion emphasizes the importance of monitoring patients for potential adverse reactions, particularly the risk of anaphylaxis. Patients receiving OMLYCLO® should be initiated in a healthcare setting equipped to manage such reactions. Symptoms of anaphylaxis can occur even after the first dose, necessitating careful observation.

In addition to the risk of anaphylaxis, healthcare providers should be vigilant for other serious conditions that may arise during treatment, including malignancies and eosinophilic conditions. The company advises against discontinuing corticosteroids abruptly when initiating OMLYCLO® treatment, as this could exacerbate asthma symptoms.

For further information on OMLYCLO® and its indications, healthcare providers and patients are encouraged to refer to the full prescribing information.

Celltrion’s Commitment to Biopharmaceutical Innovation

Celltrion is a recognized leader in the biopharmaceutical industry, specializing in the research, development, manufacturing, and marketing of innovative therapeutics. The company was among the first to launch monoclonal antibody biosimilars, contributing significantly to the global healthcare landscape. Beyond its biosimilar products, Celltrion is dedicated to advancing its pipeline with novel drugs, supporting a range of therapeutic areas including immunology, oncology, and endocrinology.

Celltrion USA, established in 2018 and based in New Jersey, focuses on expanding access to innovative biologics for U.S. patients. Its portfolio includes several FDA-approved biosimilars across various fields, reaffirming the company’s commitment to improving patient care through accessible and effective treatment options.

For more details, visit Celltrion’s official website and follow their updates on social media platforms.