Celltrion secures FDA’s 1st interchangeable status for Rituximab biosimilar

Celltrion’s corporate logo / Courtesy of Celltrion

A key cancer treatment developed by Celltrion has become the first rituximab biosimilar to receive interchangeability status from the United States Food and Drug Administration (FDA), a designation expected to strengthen its position in one of the world’s most competitive drug markets.

Celltrion said Wednesday that its blood cancer treatment Truxima (rituximab) has been granted interchangeability status by the FDA, marking the first time a rituximab biosimilar has received such recognition in the United States.

The company said the designation allows Truxima to be substituted for its reference biologic without requiring a new prescription, under conditions permitted by U.S. law, and confirms no clinically meaningful differences in safety or effectiveness.

The FDA decision also grants Truxima exclusivity tied to its status as the first interchangeable biosimilar in its class, according to the company.

Truxima is approved in the United States for all adult indications held by the reference product, including non-Hodgkin's lymphoma, chronic lymphocytic leukemia, rheumatoid arthritis and microscopic polyangiitis.

Celltrion said the designation is expected to strengthen physician confidence in prescribing the drug and improve patient access while helping reduce treatment costs.

The company said Truxima already holds a leading position in the U.S. rituximab market, ranking first in prescription volume with a 35.8 percent share as of February, according to IQVIA data.

That performance makes it the first Korean biosimilar to reach the top position in the United States rituximab market, competing against global pharmaceutical companies and the original biologic.

Celltrion said it plans to use the FDA designation as a catalyst to further strengthen its oncology biosimilar portfolio and expand its presence in the U.S. market.

A Celltrion official said Truxima has already proven its competitiveness through its market leadership and now has secured a differentiated position through interchangeability status.

The official said the company will continue working to expand treatment access and reduce healthcare costs in the United States.

This article was published with the assistance of generative AI and edited by The Korea Times.