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Celltrion's OMLYCLO® Gains FDA Approval for New 300mg Strength

On December 1, 2025, Celltrion, Inc. announced that the U.S. Food and Drug Administration (FDA) approved a 300mg presentation of OMLYCLO® (omalizumab-igec). This updated formulation represents a significant milestone as it is the first and only FDA-approved interchangeable biosimilar to XOLAIR® (omalizumab). This new strength is designed for subcutaneous injection and is available in a single-dose prefilled syringe, broadening dosing flexibility for patients suffering from various allergic conditions.

The approval of the 300mg dosage comes after the previous FDA approvals for the 75mg/0.5mL and 150mg/mL strengths in March 2025. OMLYCLO® is indicated for the management of moderate to severe persistent asthma, chronic rhinosinusitis with nasal polyps (CRSwNP), IgE-mediated food allergies in patients aged one year and older, and chronic spontaneous urticaria (CSU) in individuals aged twelve and above. The extended dosage options are a testament to Celltrion’s commitment to addressing the diverse therapeutic needs of patients across these conditions.

Dr. Juby Jacob-Nara, Senior Vice President and Chief Medical Officer at Celltrion USA, emphasized the significance of this new offering, stating, "The introduction of the 300mg OMLYCLO underscores our dedication to U.S. patients by broadening treatment choices and meeting their varying needs. This new dosing option can help reduce the number of injections required, ultimately easing treatment burdens and discomfort for patients."

Advantages of OMLYCLO® (omalizumab-igec)

The flexibility in dosing is crucial for patients who seek tailored treatment plans, which can lead to better adherence to prescribed therapies. This is particularly important for those managing chronic conditions that require long-term care. Thomas Nusbickel, Chief Commercial Officer at Celltrion USA, expressed pride in the expansion of OMLYCLO’s dosing options, noting that this advancement underlines Celltrion's mission to increase access to effective biologic treatments for U.S. patients.

The new 300mg strength is expected to provide significant benefits, including minimizing treatment disruptions for patients who may have difficulty with more frequent injections. Patients can potentially experience improved quality of life through less frequent dosing without compromising the therapeutic benefits.

What is OMLYCLO®?

OMLYCLO® (omalizumab-igec) is a biosimilar referencing XOLAIR® (omalizumab) and is designed to combat allergic conditions. It works by blocking immunoglobulin E (IgE), a substance in the immune system that causes allergic reactions. The drug was developed to match the efficacy and safety profile of its reference product, making it a crucial element in managing allergic diseases effectively.

Indications for OMLYCLO® include:

• - Moderate to severe persistent asthma: Particularly beneficial for adults and pediatric patients aged six years and older who do not have their symptoms controlled adequately with inhaled corticosteroids.
• - Chronic rhinosinusitis with nasal polyps (CRSwNP): For adults aged eighteen and older, OMLYCLO® serves as an add-on treatment for those who do not respond adequately to nasal corticosteroids.
• - IgE-mediated food allergy: Applicable to both adults and children aged one year and older, this indication focuses on reducing allergic reactions to foods that could lead to anaphylaxis, to be used alongside food allergen avoidance.
• - Chronic spontaneous urticaria (CSU): Suitable for adults and adolescents aged twelve years and older experiencing persistent symptoms despite H1 antihistamine treatment.

Safety and Post-Market Considerations

As with any medication, there are safety considerations associated with OMLYCLO®. Notably, there is a risk of anaphylaxis, which can manifest as bronchospasm, hypotension, or other serious reactions following administration. Hence, it is essential that the therapy is initiated in a healthcare setting where patients can be monitored closely.

Additionally, while patients can benefit from OMLYCLO’s advantages, healthcare professionals must educate them about the signs of potential adverse reactions, ensuring that they seek immediate medical attention should symptoms arise. Also, it’s important to note that OMLYCLO is not indicated for acute bronchospasm or status asthmaticus, nor should patients discontinue corticosteroid treatments abruptly without medical supervision.

Conclusion

With the introduction of the 300mg strength of OMLYCLO®, Celltrion is enhancing patient care by providing physicians and patients with a versatile tool to manage allergic and inflammatory conditions more effectively. This achievement not only reflects the increasing importance of biosimilars in the treatment landscape but also highlights Celltrion's commitment to meeting the evolving needs of healthcare providers and patients alike. As they continue to innovate and expand their products, Celltrion remains a key player in the biopharmaceutical industry, dedicated to improving health outcomes for those they serve.