Celltrion said on the 3rd that it received additional approval from the U.S. Food and Drug Administration (FDA) for the 300 mg prefilled syringe (PFS) formulation of the chronic spontaneous urticaria treatment "OMLYCLO (omalizumab)."
OMLYCLO is a biosimilar of Xolair, an antibody therapy jointly developed by Novartis of the United States and Roche of Switzerland. Xolair is used to treat asthma and chronic spontaneous urticaria, and recorded global sales of about 6.5 trillion won last year.
With this approval, OMLYCLO now offers three PFS products—75 mg, 150 mg, and 300 mg—identical to the original drug. In particular, the newly approved high-dose 300 mg PFS can provide a sufficient dose with a single administration for patients who previously had to receive multiple low-dose injections, improving treatment convenience.
OMLYCLO won the world's first approval as a Xolair biosimilar in May last year (Europe) and in March this year (United States). It has since completed sequential launches in major countries including Europe (EC), Australia, and Brazil, and in Europe, based on a direct sales system, it posted cumulative sales of about 47 billion won through the third quarter after launch. It is recently securing lead positions in major markets such as Germany, the United Kingdom, France, and Spain.
With this U.S. approval, Celltrion became the only biosimilar company to exclusively secure a full PFS lineup identical to the original across the United States and Europe, which account for about 89% of the global omalizumab market. The company noted that, as there are currently no followers in these two regions that have all three PFS types, the first-mover advantage is expected to grow.
A Celltrion official said, "With the additional approval of the 300 mg PFS formulation, we can offer a new treatment option to U.S. patients," and added, "Based on securing the full PFS lineup, we can provide prescriptions tailored to various patient situations, and we will do our best to expand our global market share on the strength of our product competitiveness."