Celltrion announced on the 10th that its biosimilar of the asthma and chronic spontaneous urticaria treatment Zolaire (XOLAIR, generic name omalizumab), named OMLYCLO (development code CT-P39), has obtained product approval from the U.S. Food and Drug Administration (FDA).
The company applied for product approval from the FDA last year based on the global Phase 3 results of CT-P39, obtaining approval for all indications held by the original product in the U.S. The indications include asthma, chronic rhinosinusitis with nasal polyps, chronic spontaneous urticaria, and IgE-mediated food allergy.
In particular, OMLYCLO has become the first Zolaire biosimilar to be approved in the U.S., following Europe, South Korea, the United Kingdom, and Canada. The company noted that it expects to gain an advantage in the global omalizumab market by securing a "first mover" position favorable for market dominance.
Furthermore, OMLYCLO has been recognized as an "interchangeable" biosimilar in the U.S. This means that a pharmacist can substitute it for the original product without needing a change in prescription from healthcare professionals.
Based on this competitive edge, Celltrion plans to sell OMLYCLO across the U.S. through its local corporation and aims to drive sales growth through rapid market share expansion.
The original product of OMLYCLO, Zolaire, is an antibody treatment jointly developed by multinational pharmaceutical companies Novartis and Roche, and as of 2024, its global revenue is expected to reach approximately 6 trillion won. Among this, the U.S. market size is estimated to be about 3.705 trillion won (2.47 billion Swiss francs).
With this approval, Celltrion's product lineup in the U.S. has increased to 10 products. The company has already achieved its earlier goal of an "11-product biosimilar portfolio" in South Korea and Europe. Celltrion plans to finalize the approval procedures for its remaining pipeline products promptly.