Celltrion said on Nov. 28 (local time) that it received permission from the U.S. Food and Drug Administration (FDA) to sell rituximab biosimilar (TRUXIMA).
TRUXIMA is an anti-cancer antibody called "biosimilar" that is used to treat non-Hodgkin's lymphoma, a type of blood cancer. The original drug is Mapthera sold by Roche.
With the approval, the company is expected to gain significant market preoccupation by entering the U.S., the world`s largest rituximab market. The U.S. market for rituximab is worth 5 trillion won, accounting for 56% of the global rituximab sales.
In particular, TRUXIMA will be sold in the U.S. market for at least one year without competition from other biosimilars. It is because Sandoz' Rixathon, which is expected to be the U.S. biosimilar competitor, recently gave up entering the U.S. market.
The multinational pharmaceutical company TEVA will be in charge of sales in the U.S. TEVA, which has the sales right of TRUXIMA in North America, has established a strong portfolio and marketing network in the global market for generic and innovative medicines and anti-cancer field.
"The U.S. approval of TRUXIMA is an important milestone not only for all employees of the Celltrion, but also for patients in the U.S. who need a rituximab biosimilar treatment," said a Celltrion official.
