FDA Approves Omlyclo as First Interchangeable Omalizumab Biosimilar

The US Food and Drug Administration (FDA) approved Omlyclo (omalizumab-igec) as the first biosimilar to omalizumab designated as interchangeable with omalizumab (Xolair), according to a Celltrion news release.1

Omlyclo is indicated for the treatment of moderate to severe persistent asthma, chronic rhinosinusitis with nasal polyps (CRSwNP), IgE-mediated food allergy, and chronic spontaneous urticaria (CSU) in patients who remain symptomatic despite antihistamine therapy. This approval, based on Phase III clinical trial data involving adult patients with CSU, demonstrates comparable efficacy and safety to Xolair at multiple dosing regimens and supports interchangeability, a designation permitting pharmacy-level substitution without additional prescriber authorization.1

"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," said Hetal Patel, Vice President of Medical Affairs at Celltrion USA, in a news release. "The interchangeability designation of Omlyclo reinforces confidence among physicians and patients that there is no decrease in effectiveness or increase in safety risk associated with switching between Omlyclo and the reference product."1

The FDA approval and designation of interchangeability are based on comprehensive clinical evidence, including results from a global Phase III clinical trial involving 619 adult patients with CSU up to Week 40. Patients were randomized to receive 300 mg or 150 mg of Omlyclo or reference product every 4 weeks.1

From Week 12, patients who received Omlyclo were continued on the treatment, and patients who received 300mg of the reference product were re-randomized in a 1:1 ratio to switch to Omlyclo or to continue reference product. From Week 24, patients were followed up until Week 40 without dosing. The result demonstrated the comparable efficacy and safety of Omlyclo to reference product during both treatment and off-dose periods.1

"The approval of Omlyclo could have a meaningful impact for the medical community and patients, offering a high quality and affordable treatment option, while reducing the burden of healthcare costs," said Thomas Nusbickel, Chief Commercial Officer at Celltrion USA, in the news release. "With our integrated development, manufacturing, and commercialization platform, Celltrion remains committed to alleviating treatment costs and delivering life-changing medicines to support patients with allergic conditions in the U.S."1

Indications for Omylclo include:

• Moderate to severe persistent asthma in adults and pediatric patients ≥6 years of age with a positive skin test or in vitro reactivity to a perennial aeroallergen and symptoms that are inadequately controlled with inhaled corticosteroids.
• CRSwNP in adult patients ≥18 years of age with inadequate response to nasal corticosteroids, as add-on maintenance treatment.
• IgE-mediated food allergy in adult and pediatric patients aged ≥1 year age for the reduction of allergic reactions (Type I), including anaphylaxis, that may occur with accidental exposure to one or more foods. To be used in conjunction with food allergen avoidance.
• CSU in adults and adolescents ≥12 years of age who remain symptomatic despite H1 antihistamine treatment.1

Omlyclo is not indicated for acute bronchospasm or status asthmaticus, emergency treatment of allergic reactions, including anaphylaxis, or other forms of urticaria.1

Reference

1. Celltrion. U.S. FDA approves Celltrion's OMLYCLO® (omalizumab-igec) as the first and only biosimilar with interchangeability designation referencing XOLAIR® [news release]. March 9, 2025. Accessed March 10, 2025. https://www.prnewswire.com/news-releases/us-fda-approves-celltrions-omlyclo-omalizumab-igec-as-the-first-and-only-biosimilar-with-interchangeability-designation-referencing-xolair-301769585.html