[Edaily Reporter SONG YOUNG-DOO ] Celltrion(068270)announced on the 1st that its blood cancer treatment “Truxima” (active ingredient: rituximab) has obtained interchangeability status from the U.S. Food and Drug Administration (FDA).

Truxima is the first rituximab biosimilar to obtain interchangeability status in the United States. As a result, Celltrion has secured the exclusivity granted to the first biosimilar to achieve interchangeability.

Truxima has already received U.S. approval for all adult indications held by the originator drug, including non-Hodgkin lymphoma (NHL), chronic lymphocytic leukemia (CLL), rheumatoid arthritis (RA), and microscopic polyangiitis (MPA).

Interchangeability is a system under which the FDA recognizes that a biosimilar can be substituted for the originator drug without any additional clinical concerns. With this approval, Truxima has been officially recognized as having no clinically significant differences in efficacy and safety when substituted for the originator drug.

Accordingly, the company expects this to not only boost prescribing confidence among healthcare professionals but also have a positive impact on patient access to treatment and the reduction of healthcare costs.

Amid ongoing discussions in the U.S. regarding changes to the biosimilar regulatory environment, Truxima has secured a unique competitive advantage as the only rituximab biosimilar to have been recognized by the FDA as interchangeable, regardless of regulatory changes.

Its market performance has already been proven. According to IQVIA, a pharmaceutical market research firm, Truxima ranked first in the U.S. rituximab market as of February this year, with a 35.8% market share based on prescription volume. Since entering the U.S. market, it has surpassed products from global pharmaceutical companies—including the originator drug—to become the first Korean biosimilar to claim the top market share position in the U.S.

Sales growth continues to accelerate. Last year, Truxima generated over 3000억 won in sales in North America, including the U.S., marking year-over-year growth of more than 40%. It has now established itself as one of Celltrion’s core global products.

Celltrion expects that securing this interchangeability status will further strengthen its competitive edge in the U.S. rituximab market and positively impact the expansion of its portfolio of follow-on oncology biosimilars.

A Celltrion spokesperson stated, “Truxima has proven its competitiveness by ranking first in prescriptions in the U.S. rituximab market, and by securing the first-ever interchangeability status, it has now established a distinct competitive edge.” The spokesperson added, “Based on verified clinical data and prescribing evidence, we will strive to further strengthen the product’s position in the U.S. market and contribute to expanding patient access to treatment and reducing healthcare costs.”