Celltrion Gains FDA Approval for 300mg OMLYCLO® Biosimilar

Celltrion, Inc. has received approval from the U.S. Food and Drug Administration (FDA) for a new 300 mg strength of OMLYCLO® (omalizumab-igec). This product is notable for being the first and only FDA-approved interchangeable biosimilar to XOLAIR® (omalizumab). The new formulation comes in a 300 mg/2 mL solution and is delivered via a single-dose prefilled syringe for subcutaneous injection.

The approval was announced on December 3, 2025, and marks a significant step in expanding treatment options for patients with allergic and inflammatory conditions. OMLYCLO will be marketed and distributed in the United States exclusively by Celltrion USA, Inc. The FDA had previously approved OMLYCLO in March 2025 in 75 mg/0.5 mL and 150 mg/mL strengths for various conditions, including moderate to severe persistent asthma and chronic rhinosinusitis with nasal polyps.

Enhancing Patient Care with Expanded Dosing Options

Dr. Juby Jacob-Nara, Senior Vice President and Chief Medical Officer at Celltrion USA, emphasized the importance of this new dosage form. “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,” she stated. This new dosing option can potentially reduce the number of injections required, thereby easing treatment burdens for patients suffering from these conditions.

Thomas Nusbickel, Chief Commercial Officer at Celltrion USA, expressed pride in the expansion of OMLYCLO’s dosing options. He stated, “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.” This sentiment reflects Celltrion’s commitment to enhancing access to biologic treatments in the U.S. healthcare landscape.

About OMLYCLO® and Its Indications

OMLYCO® (omalizumab-igec) is a biosimilar referencing XOLAIR® and is indicated for the treatment of several allergic and inflammatory conditions. It is important to note that OMLYCLO is not intended for the emergency treatment of acute bronchospasm or status asthmaticus and should not be used for the emergency treatment of allergic reactions, including anaphylaxis.

The FDA and the European Commission approved OMLYCLO in March 2025 and May 2024, respectively. The product’s unique formulation allows for therapeutic equivalence to XOLAIR based on comprehensive clinical evidence.

Patients and healthcare providers should be aware of the risks associated with OMLYCLO, particularly the potential for serious allergic reactions, including anaphylaxis. Health care providers are advised to initiate OMLYCLO therapy in a healthcare setting equipped to manage such risks and to monitor patients closely post-administration.

Celltrion is a pioneering biopharmaceutical company dedicated to improving patient outcomes through innovative therapeutics. Established in South Korea, the company specializes in the research, development, manufacturing, and marketing of biosimilars. The introduction of OMLYCLO’s 300 mg presentation is part of Celltrion’s broader strategy to enhance access to biologic treatments worldwide.

The company’s U.S. subsidiary, Celltrion USA, was formed in 2018 and focuses on expanding access to innovative biologics for patients in the United States. With a diverse portfolio of FDA-approved biosimilars, including INFLECTRA® and TRUXIMA®, Celltrion USA is committed to ensuring that high-quality biopharmaceuticals are accessible to patients.

For more information about Celltrion and its products, visit the company’s official website.