FDA Approves 300mg Strength of Celltrion's OMLYCLO, First Interchangeable Biosimilar to Xolair
Key Insights
The FDA has approved a new 300mg/2mL prefilled syringe presentation of OMLYCLO (omalizumab-igec (search)), expanding dosing flexibility for patients with allergic diseases.
OMLYCLO remains the first and only biosimilar designated as interchangeable with XOLAIR (omalizumab) for multiple indications including asthma and chronic urticaria.
The new higher-dose formulation can help reduce the number of required injections and ease treatment burden for patients with allergic and inflammatory conditions.
The U.S. Food and Drug Administration has approved a new 300mg/2mL strength of OMLYCLO (omalizumab-igec (search)) in a single-dose prefilled syringe for subcutaneous injection, announced Celltrion Inc. on December 1, 2025. OMLYCLO maintains its distinction as the first and only biosimilar designated as interchangeable with XOLAIR (omalizumab), with the new presentation designed to expand dosing flexibility for patients with certain allergic diseases.
Enhanced Treatment Options
The approval of the 300mg presentation builds upon the FDA's March 2025 approval of OMLYCLO in 75 mg/0.5 mL and 150 mg/mL solutions in single-dose prefilled syringes. The biosimilar is approved for treating moderate to severe persistent asthma (search), chronic rhinosinusitis with nasal polyps (search) (CRSwNP), Immunoglobulin E (IgE (search))-mediated food allergy, and chronic spontaneous urticaria (search) (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 (search). "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."
Clinical Applications and Safety Profile
OMLYCLO is indicated for multiple allergic conditions across different age groups. For moderate to severe persistent asthma (search), it is approved for adults and pediatric patients ≥6 years of age with positive skin test or in vitro reactivity to perennial aeroallergens whose symptoms remain inadequately controlled with inhaled corticosteroids. In chronic rhinosinusitis with nasal polyps (search), the treatment serves as add-on maintenance therapy for adult patients ≥18 years with inadequate response to nasal corticosteroids.
For IgE (search)-mediated food allergies, OMLYCLO is indicated for adults and pediatric patients aged ≥1 year to reduce allergic reactions, including anaphylaxis (search), that may occur with accidental food exposure, used in conjunction with food allergen avoidance. The biosimilar also treats chronic spontaneous urticaria (search) in adults and adolescents ≥12 years who remain symptomatic despite H1 antihistamine treatment.
Safety Considerations
The FDA approval includes a boxed warning for anaphylaxis (search), as omalizumab products have been associated with severe allergic reactions presenting as bronchospasm, hypotension, syncope, urticaria, and angioedema. Anaphylaxis can occur as early as after the first dose but may also develop beyond one year of regular treatment. Healthcare providers must initiate OMLYCLO therapy in healthcare settings and closely observe patients for appropriate periods after administration.
Common adverse reactions vary by indication. In asthma patients ≥12 years, reactions reported in ≥1% include arthralgia, general pain, leg pain, fatigue, dizziness, fracture, arm pain, pruritus, dermatitis, and earache. For chronic rhinosinusitis with nasal polyps (search), reactions in ≥3% of adults include headache, injection site reactions, arthralgia, upper abdominal pain, and dizziness.
Market Access and Distribution
In the United States, OMLYCLO will be marketed and distributed exclusively by Celltrion USA (search), Inc. Thomas Nusbickel, Chief Commercial Officer at Celltrion USA, emphasized the company's commitment to increasing access to biologic treatments, stating, "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."
OMLYCLO was previously approved by the European Commission in May 2024, demonstrating the biosimilar's global regulatory acceptance. The comprehensive data and clinical evidence confirming therapeutic equivalence to XOLAIR supported the interchangeable designation across all approved indications.