FDA Approves Celltrion’s Xolair Biosimilar Omlyclo for Multiple Indications

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The FDA has approved Celltrion’s Omlyclo (omalizumab-igec), the first and only biosimilar to Xolair (omalizumab). Omlyclo is indicated for the treatment of moderate to severe persistent asthma, chronic rhinosinusitis with nasal polyps (CRSwNP), immunoglobulin E (IgE)-mediated food allergy, and chronic spontaneous urticaria (CSU).¹

"We are proud to achieve the approval of the first biosimilar to omalizumab in the US, 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, VP, medical affairs, Celltrion USA, in a press 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."

Approval was based on results from a Phase III clinical trial that included 619 patients with CSU. All patients were randomly assigned to receive either Omlyclo in 300 mg or 150 mg doses or Xolair every four weeks for up to 40 weeks. The study also included a switch at week 12, with patients who had initially been treated with Xolair re-randomized in a 1:1 ratio to either continue receiving Xolair or transition to Omlyclo. Between week 24 and week 40, patients continued follow-up without further dosing.

Adverse events (AEs) varied by indication. In patients with asthma, the most common AEs in those under 12 years of age were arthralgia; general pain; leg pain; fatigue; dizziness; fracture; arm pain; pruritus; dermatitis; and earache. Among patients aged six to <12 years, common AEs included nasopharyngitis; headache; pyrexia; upper abdominal pain; streptococcal pharyngitis; otitis media; viral gastroenteritis; arthropod bites; and epistaxis. In patients with CRSwNP, AEs included headache; injection site reactions; arthralgia; upper abdominal pain; and dizziness. For those with IgE-mediated food allergies, the most common AEs were injection site reactions and pyrexia. Lastly, common AEs for patients with CSU included nausea; nasopharyngitis; sinusitis; upper respiratory tract infections; arthralgia, headache; and cough.

Celltrion warned that Omlyclo is contraindicated in patients with hypersensitivity to any of its ingredients. It has also been associated with anaphylaxis, malignancies, eosinophilia, parasitic infections, and acute asthma symptoms.¹

The approval of Omlyclo marks the second biosimilar manufactured by Celltrion to gain FDA approval in March. Last week, the FDA also approved Stoboclo (CT-P41, denosumab-bmwo) and Osenvelt (CT-P41, denosumab-bmwo), biosimilars to Amgen’s Prolia and Xgeva, respectively.²

According to Medscape, approximately 15% to 20% of people in the United States are likely to develop urticaria during their lifetime. While incidence rates are similar between men and women, women have a slightly higher likelihood of developing the condition. Although urticaria can occur at any age, it is most commonly seen in people in their 40s and 50s.³

A study published in The Clinical Journal of Medicine estimates the global prevalence of CSU to be between 0.5% and 1% of the general population. The study estimated that most cases of CSU occur in individuals between 20 and 40 years of age.⁴

"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, Celltrion USA, in the press 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 US."

References

1. U.S. FDA approves Celltrion's OMLYCLO® (omalizumab-igec) as the first and only biosimilar with interchangeability designation referencing XOLAIR®. PR Newswire. 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-302396468.html

2. FDA Approves Celltrion’s Biosimilars Stoboclo and Osenvelt. PharmExec. March 4, 2025. Accessed March 10, 2025. https://www.pharmexec.com/view/fda-approves-celltrion-biosimilars-stoboclo-osenvelt

3. Urticaria. Medscape. Accessed March 10, 2025. https://emedicine.medscape.com/article/762917-overview#a2

4. Epidemiological and Clinical Characteristics of Adult and Pediatric Patients with Chronic Spontaneous Urticaria. MDPI. Accessed March 10, 2025. https://www.mdpi.com/2077-0383/12/23/7482