Celltrion said on the 1st that the U.S. Food and Drug Administration (FDA) has designated its blood cancer treatment Truxima (ingredient rituximab) as an "interchangeable" biosimilar that can be prescribed in place of the original medicine.
Among rituximab biosimilars, Truxima is the first to obtain interchangeability status in the United States. As a result, Truxima also secured the exclusivity granted to the first interchangeable biosimilar.
Truxima is a biosimilar of Roche's "Rituxan" and is Celltrion's first blood cancer treatment. In the United States, it is used to treat all adult diseases covered by the original medicine, including non-Hodgkin lymphoma (NHL), chronic lymphocytic leukemia (CLL), rheumatoid arthritis (RA), and microscopic polyangiitis (MPA).
Interchangeability is a status in which the FDA recognizes that substituting between an original medicine and a biosimilar shows no clinical difference in efficacy and safety. With this approval, Truxima has secured an official basis to be substituted and prescribed for the original medicine.
Celltrion expects the new status to boost U.S. providers' confidence in prescribing and to positively affect expanded patient access to treatment and reduced medical costs.
Although discussions on easing biosimilar regulations are continuing in the United States, Truxima's competitive edge is expected to hold. Regardless of any policy changes, Truxima has secured differentiated competitiveness as the only rituximab biosimilar officially recognized by the FDA as substitutable with the original medicine.
Its market performance has already been proven. According to IQVIA, Truxima ranked No. 1 with a 35.8% share by prescription volume in the U.S. rituximab market as of February this year. This is the first case in which a Korea-made biosimilar topped market share in the United States ahead of the original medicine and products from global pharmaceutical companies.
Sales growth is continuing. Truxima generated more than 300 billion won in sales last year in North America, including the United States, growing by more than 40% from a year earlier. It has now become one of Celltrion's core revenue sources.
A Celltrion official said, "Truxima has proven its product competitiveness by ranking No. 1 in prescriptions in the U.S. rituximab market and has now secured the first interchangeability status," and added, "Based on validated clinical data and prescribing grounds, we will do our best to improve patients' access to treatment and ease medical cost burdens."