Celltrion's Truxima Becomes First Rituximab Biosimilar to Achieve Interchangeability Status in the U.S.

Celltrion Global Biopharmaceutical Research Center [Photo=Celltrion]

Celltrion has announced that its blood cancer treatment Truxima (active ingredient: rituximab) has become the first rituximab biosimilar to receive interchangeability status from the U.S. Food and Drug Administration (FDA). This achievement is expected to enhance its competitive edge in the local market alongside securing exclusivity rights.
On July 1, Celltrion confirmed that it has obtained the interchangeability designation for Truxima from the FDA. Truxima is the first biosimilar of rituximab to achieve this status in the United States, and it has also secured exclusivity rights typically granted to the first interchangeable biosimilar.
Truxima is a blood cancer treatment developed by Celltrion. It has received approval in the U.S. for all adult indications held by the original drug, including non-Hodgkin lymphoma (NHL), chronic lymphocytic leukemia (CLL), rheumatoid arthritis (RA), and microscopic polyangiitis (MPA).
Interchangeability status recognizes the potential for switching between the original drug and the biosimilar. This designation presents an opportunity for domestic companies with U.S. approval and local sales experience to expand their access to pharmacies. With this approval, Truxima has been officially recognized as clinically equivalent to the original drug in terms of efficacy and safety, providing a stronger basis for prescriptions.
Truxima has already captured a significant market share in the U.S. According to market research firm IQVIA, as of February this year, Truxima held a 35.8% share of U.S. prescriptions, ranking first.
With the acquisition of this interchangeability status, Celltrion aims to strengthen its position in the U.S. rituximab market and continue expanding its portfolio of follow-up cancer biosimilars.
A Celltrion representative stated, "Truxima has not only achieved the top prescription ranking in the U.S. market but has also secured interchangeability status. We will contribute to expanding treatment accessibility based on verified clinical data and prescription evidence."

* This article has been translated by AI.