Celltrion Receives US Approval for Xolair Biosimilar 'Omliclo'

Maximizing Competitiveness in the 6 Trillion KRW Global Market

Celltrion announced on the 10th that its biosimilar of XOLAIR (active ingredient omalizumab), a treatment for asthma and chronic spontaneous urticaria, named OMLYCLO (development code CT-P39), has received approval from the U.S. Food and Drug Administration (FDA).

Based on the global Phase 3 clinical trial results of CT-P39, Celltrion applied for FDA approval last year and obtained authorization for all indications held by the original drug in the U.S., including asthma, chronic rhinosinusitis with nasal polyps, chronic spontaneous urticaria, and immunoglobulin E (IgE)-mediated food allergy.

In particular, OMLYCLO secured the 'First Mover' status as the first XOLAIR biosimilar approved in the U.S., following prior approvals in major global markets such as Europe (EC), South Korea, the United Kingdom, and Canada. Accordingly, it is expected to gain a competitive edge in the global omalizumab market through early market capture.

Simultaneously, OMLYCLO was recognized as an 'interchangeable' biosimilar in the U.S., meaning that pharmacies can substitute the original product without requiring a prescription change by healthcare providers. Leveraging this competitiveness, Celltrion plans to sell OMLYCLO nationwide through its local subsidiary, driving sales growth through rapid market penetration and increased market share.

The original drug XOLAIR, of which OMLYCLO is a biosimilar, recorded global sales of approximately KRW 6 trillion as of last year. The U.S. market alone is estimated to be about KRW 3.705 trillion (2.47 billion Swiss francs).

With this approval, Celltrion added four products, including OMLYCLO, the autoimmune disease treatment APTOSMA, and the bone disease treatments Prolia and Xgeva, to its U.S. product portfolio in the first quarter of this year, securing a total of 10 products in the U.S. This makes the goal of having 11 biosimilar products in the portfolio, already achieved in South Korea and Europe, increasingly visible in the U.S. Celltrion plans to promptly complete the approval process for the remaining biosimilar pipeline products.

A Celltrion official stated, "Not only has OMLYCLO obtained approval as the first mover in the world's largest pharmaceutical market, the U.S., but it has also secured interchangeable status, allowing us to gain a favorable position in the early market launch." He added, "We will do our best to ensure that OMLYCLO establishes itself in the U.S. and global markets and drives sales growth."

Meanwhile, Celltrion recently announced that it achieved record-high sales of KRW 3.5 trillion last year, meeting its sales target. This year, the company aims to reach annual sales of KRW 5 trillion and plans to secure a total of 22 products by 2030, targeting annual sales of KRW 12 trillion.