Celltrion said it has received approval from the U.S. FDA for its biosimilar Omlyclo, a biosimilar referencing Xolair.
Celltrion secures FDA approval for Omlyclo, the first interchangeable biosimilar to Xolair in the U.S., strengthening its position in the global omalizumab market.
Celltrion secures FDA approval for Omlyclo, the first interchangeable biosimilar to Xolair in the U.S., strengthening its position in the global omalizumab market.
Omlyclo is an antibody biopharmaceutical with the same composition as the original drug, Novartis' Xolair, which has indications that include allergic asthma and chronic idiopathic urticaria. Xolair recorded approximately 6 trillion won ($4.1 billion) in global sales in 2024, with the U.S. market accounting for around 3.7 trillion won.
Based on the results of its global phase 3 clinical trials, Celltrion submitted its Biologics License Application (BLA) to the FDA last year. The approval covers the full-label indications of the reference product, including asthma, chronic rhinosinusitis with nasal polyps (CRSwNP), chronic spontaneous urticaria (CSU), and IgE-mediated food allergies.
With the approval, Omlyclo becomes the first FDA-approved biosimilar to Xolair in the U.S., securing Celltrion a first-mover advantage in the global omalizumab biosimilar market. The company expects this strategic positioning to drive market penetration and sales growth.
Omlyclo has also been designated as an interchangeable biosimilar in the U.S., allowing pharmacists to substitute it for Xolair without requiring prescriber approval. The company expects the designation is expected to facilitate rapid market adoption and increase accessibility for patients.
This approval marks a milestone for Celltrion, which has now added four new products to its U.S. portfolio in the first quarter of 2025, including the autoimmune treatment Aptozma, a biosimilar referencing Acterma (autoimmune disease treatment), and Stoboclo and Osenvelt, a biosimilar referencing Prolia and Xgeva biosimilar (postmenopausal osteoporosis and skeletal-related complication treatment).
“Omlyclo’s approval as the first interchangeable Xolair biosimilar in the U.S. gives us a competitive edge in the early market phase,” a Celltrion official said. “We are committed to ensuring its successful launch and expansion in global markets.”
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Lee Han-soo corea022@docdocdoc.co.kr
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