Celltrion Wins FDA Nod for Xolair Biosimilar OMLYCLO

Celltrion CI

[Song Young-doo, Edaily Reporter] Celltrion’s Xolair(omalizumab) biosimilar OMLYCLO received commercialization approval from the U.S. Food and Drug Administration, the company said Monday. The drug is used to treat asthma and chronic spontaneous urticaria.

Celltrion submitted the FDA application last year based on results from its global Phase 3 clinical trial for CT-P39. The approval covers all indications held by the original drug in the United States, including asthma, chronic rhinosinusitis with nasal polyps, chronic spontaneous urticaria, and immunoglobulin E-mediated food allergies.

OMLYCLO is the first Xolair biosimilar to receive approval in major global markets, including the European Union, South Korea, the United Kingdom, and Canada. With this first-mover status, Celltrion expects to gain a competitive edge in the global omalizumab market.

The biosimilar has also been designated as interchangeable in the United States, meaning pharmacies can substitute it for the original drug without requiring a prescription change from health care providers. Celltrion plans to distribute OMLYCLO nationwide through its local subsidiary, aiming for rapid market penetration and increased market share.

As of 2024, the original drug Xolair has global sales of about 6 trillion won, with the U.S. market alone accounting for roughly 3.7 trillion won (24.7 billion Swiss francs).

With this approval, Celltrion has added four new products to its U.S. portfolio in the first quarter of this year, including OMLYCLO, the autoimmune disease treatment Aptozuma, and the osteoporosis treatment Prolia-Xgeva. The company now holds 10 products in the U.S. market, aligning with its goal of securing a portfolio of 11 biosimilars, a milestone already reached in South Korea and Europe. Celltrion is expediting approval processes for its remaining biosimilar pipeline.

“OMLYCLO has secured first-mover approval in the world’s largest pharmaceutical market and gained interchangeable status, giving us a significant advantage at launch,” a Celltrion spokesperson said. “We will ensure that OMLYCLO establishes a strong presence in the U.S. and global markets to drive revenue growth.”

Celltrion recently announced record-breaking annual sales of 3.5 trillion won for 2023. The company aims to achieve 5 trillion won in annual sales this year and expand its product lineup to 22 by 2030, with a long-term revenue target of 12 trillion won.

송영두 (songzio@edaily.co.kr)