Celltrion announced on the 1st that the U.S. Food and Drug Administration (FDA) has granted interchangeable status to Truxima (active ingredient: rituximab), its biosimilar used to treat blood cancers and autoimmune diseases.
With this regulatory milestone, Truxima becomes the first rituximab biosimilar to achieve interchangeable status in the United States. Celltrion confirmed that the drug has also secured the period of marketing exclusivity automatically granted to the first interchangeable biosimilar of its kind.
An interchangeable designation means that the biosimilar can be substituted for the original reference drug at the pharmacy level without the intervention of the prescribing healthcare provider. The FDA's approval recognizes Truxima as having no clinically meaningful differences in safety, purity, and potency compared to the reference product, ensuring identical efficacy even when patients switch between the two.
Truxima is approved in the U.S. for all adult indications held by the original drug. These include non-Hodgkin lymphoma (NHL), chronic lymphocytic leukemia (CLL), rheumatoid arthritis (RA), and microscopic polyangiitis (MPA).
The approval is expected to further bolster Truxima’s leading market presence. According to market research firm IQVIA, Truxima ranked first in the U.S. rituximab market as of February this year, commanding a 35.8% market share based on prescription volume.
Financial data from Hyundai Motor Securities highlights Truxima's significant contribution to Celltrion's portfolio. The drug generated approximately 527.0 billion won in total sales last year, making up 12.7% of the company's total annual revenue of 4.163 trillion won. Out of that total, Truxima's North American sales alone were reported at 300.0 billion won.
"Truxima already ranks number one in prescriptions within the U.S. rituximab market, and it has now become the first to obtain interchangeable status as well," a Celltrion official said.
