Celltrion Applies for FDA Approval of Asthma Drug Zolair Biosimilar 'CT-P39' in the US

Celltrion announced on the 11th that it has completed the application for approval of CT-P39, a biosimilar of Xolair, a treatment for asthma and chronic spontaneous urticaria, to the U.S. Food and Drug Administration (FDA).

Incheon Songdo Celltrion Plant 2 exterior view. / Incheon - Photo by Hyunmin Kim kimhyun81@

This approval application covers the major indications of the original drug, including asthma, chronic rhinosinusitis, food allergy, and chronic spontaneous urticaria. Celltrion had previously applied for approval of CT-P39 in Europe, Canada, and South Korea last year.

Notably, this U.S. approval application was made as an interchangeable biosimilar. Once designated as an interchangeable biosimilar, pharmacies can substitute CT-P39, which has been recognized for equivalent efficacy and safety, for Xolair even if the doctor prescribes the original drug Xolair. The company expects this will enable faster market expansion.

Celltrion demonstrated efficacy equivalence and similarity in safety of CT-P39 compared to the original drug in 619 patients with chronic spontaneous urticaria across six European countries, including Poland and Bulgaria.

Xolair, the original drug of CT-P39, recorded global sales of approximately $3.9 billion (about 5 trillion KRW) last year, making it a blockbuster product. The substance patent has already expired, and the formulation patent is set to expire this month in Europe and in November next year in the U.S.

A Celltrion official stated, "CT-P39 demonstrated efficacy equivalence compared to the original drug in global Phase 3 clinical trials and confirmed safety faster than competitors, making it highly likely to be a first mover. We will also expedite the remaining procedures to finalize approval and thoroughly prepare for smooth market penetration after approval."

This content was produced with the assistance of AI translation services.