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Celltrion's OMLYCLO® Gains FDA Approval as Biosimilar

In an important milestone for biopharmaceuticals, the U.S. Food and Drug Administration (FDA) has officially approved OMLYCLO® (omalizumab-igec), developed by Celltrion. This medication stands out as the first and only interchangeable biosimilar that references XOLAIR® (omalizumab). Its approval is not just a win for Celltrion, but a significant leap toward improving access to treatment options for patients struggling with various allergic and respiratory conditions.

Significance of Interchangeability

Interchangeability is a critical designation that provides confidence among healthcare providers and patients regarding the safety and effectiveness of switching from a brand-name drug to its biosimilar. With this approval, OMLYCLO establishes itself as a competitive alternative to XOLAIR, which has been a leading treatment for moderate to severe persistent asthma, chronic rhinosinusitis with nasal polyps (CRSwNP), IgE-mediated food allergies, and chronic spontaneous urticaria (CSU).

Celltrion's Vice President of Medical Affairs, Hetal Patel, emphasized the importance of this approval, stating, "We are proud to achieve the approval of the first biosimilar to omalizumab in the U.S., which will help broaden access to this important medicine for patients with allergic and respiratory conditions as well as for physicians, payers, and providers."

Clinical Evidence

The FDA's decision was strongly supported by comprehensive clinical data gathered from a global Phase III clinical trial that involved 619 adult participants with CSU. The study demonstrated that OMLYCLO was as effective and safe as the reference product across both treatment and off-treatment periods. Participants were administered either OMLYCLO or XOLAIR every four weeks, leading to robust results affirming the biosimilar's therapeutic equivalence.

This thorough examination assures healthcare professionals that patients can safely switch from XOLAIR to OMLYCLO without fear of reduced effectiveness or increased safety risks.

Potential Impact on Healthcare Costs

The advent of OMLYCLO is significant not only for its clinical applications but also for its potential to make asthma and allergy treatments more affordable. According to Thomas Nusbickel, Chief Commercial Officer at Celltrion USA, the approval could meaningfully impact the medical community and patients, providing a high-quality, cost-effective treatment option while alleviating overall healthcare expenses. This aligns with Celltrion's commitment to improving patient access to innovative biologics.

Indications for Use

OMLYCLO is indicated for the treatment of multiple conditions:

• - Moderate to severe persistent asthma in adults and children ages six and up with confirmed reactivity to perennial allergens.
• - Chronic rhinosinusitis with nasal polyps (CRSwNP) as an add-on treatment for adults over 18 years with inadequate response to nasal corticosteroids.
• - IgE-mediated food allergies in individuals aged one year and older, aimed at reducing allergic reactions to food exposure, used in conjunction with allergen avoidance strategies.
• - Chronic spontaneous urticaria (CSU) in those aged 12 and older who are symptomatic despite antihistamine therapy.

Caution: Safety Information

As with any medication, OMLYCLO is not without its risks. The product carries a warning of potential anaphylactic reactions, which may occur after administration and require healthcare providers to be prepared to manage such emergencies. The proactive approach to patient treatment includes monitoring for signs of these severe reactions, particularly given the history of anaphylaxis associated with similar treatments.

Celltrion insists on careful patient selection for self-administration of OMLYCLO, based on criteria designed to mitigate the risks of anaphylaxis, ensuring that patients are fully aware of the signs and symptoms that warrant immediate medical attention.

Conclusion

Celltrion's OMLYCLO® marks a transformative moment in the biopharmaceutical landscape, particularly for those managing asthma and allergies. Its designation as an interchangeable biosimilar reflects both rigorous scientific evaluation and a commitment to patient accessibility, potentially paving the way for more competitive pricing in a crucial area of healthcare. As OMLYCLO becomes available, it heralds new possibilities for patients and providers alike—facilitating better health outcomes and lower treatment costs.

For further information and ongoing updates about Celltrion and its products, please visit Celltrion's Official Website.