Celltrion said on the 1st that its blood cancer treatment Truxima (rituximab) has been granted interchangeability status by the U.S. Food and Drug Administration (FDA).
Truxima is the first rituximab biosimilar in the United States to receive interchangeability designation. With this approval, it also secures exclusivity rights granted to the first interchangeable biosimilar.
Truxima is a blood cancer treatment developed by Celltrion and has already been approved in the United States for all adult indications held by the reference product, including non-Hodgkin’s lymphoma (NHL), chronic lymphocytic leukemia (CLL), rheumatoid arthritis (RA), and microscopic polyangiitis (MPA).
Non-Hodgkin’s lymphoma is one of the most common cancers of the lymphatic system, and rituximab is widely used as a standard therapy for the disease.
Interchangeability status recognizes that a biosimilar can be substituted for the reference product without the intervention of the prescribing physician. With this designation, Truxima has been formally recognized as having no clinically meaningful differences in efficacy and safety when used in place of the originator, strengthening its prescribing credibility.
The approval is expected to further increase physician confidence in prescribing Truxima and contribute to broader patient access and reduced healthcare costs.
According to market research firm IQVIA, Truxima held a 35.8% market share in the U.S. rituximab market as of February this year, ranking first in prescription volume.
Its commercial performance has also remained strong. Truxima generated more than $2 billion in sales in North America, including the United States, last year alone, marking more than 40% growth from the previous year and establishing itself as one of Celltrion’s key revenue drivers.
Celltrion said it plans to use the interchangeability designation as a catalyst to further strengthen Truxima’s competitiveness in the U.S. rituximab market and reinforce its oncology biosimilar portfolio.