Kim Byung-ho and Minu Kim
Celltrion Inc. Wednesday announced the U.S. Food and Drug Administration (FDA) has approved Truxima, a monoclonal antibody biosimilar to Rituxan (rituximab) for the treatment of adult patients with non-Hodgkin’s lymphoma.
Truxima is the first rituximab biosimilar to be approved in the U.S. for three non-Hodgkin’s lymphoma indications and may help provide greater accessibility for patients, Celltrion said in a statement.
It also marks the Korean biopharmaceutical firm’s second milestone in the U.S. after it successfully penetrated the world’s largest healthcare market with its autoimmune disease biosimilar Remsima in 2016.
The FDA approval comes after an advisory panel to the agency recommended the drug be cleared for sale last year.
Celltrion’s Remsima, which sells under the brand name of Inflectra in the U.S., the first biosimilar to Remicade, was approved in April 2016 after a panel’s approval recommendation in February of the same year.
With the latest triumph, Celltrion’s position as a first-mover in the biosimilar market is expected to be further strengthened. Rituximab sales amount to about $4.45 billion in the U.S., some 56 percent of worldwide sales.
Truxima now sells in 18 European countries after its first approval in Europe in February last year.
Teva Pharmaceutical Industries Ltd. will be responsible for selling Truxima across the U.S.
As of 01:25 pm on Thursday in Seoul trading, Celltrion shares were trading 2.12 percent, or 5,000 won, higher at 241,000 won.