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Celltrion Receives FDA Approval for Biosimilar Truxima
Ready for Entry into U.S. Market
Celltrion Receives FDA Approval for Biosimilar Truxima
  • By Choi Moon-hee
  • November 30, 2018, 10:51
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Celltrion’s anticancer drug Truxima has obtained marketing approval from the U.S. Food and Drug Administration (FDA).

Celltrion has obtained marketing approval for its anticancer drug Truxima from the U.S. Food and Drug Administration (FDA), the company annouced on Nov. 29.

Truxima is a biosimilar to Rituxan developed by Roche, a global pharmaceutical company. It is mainly used for treatment of non-Hodgkin's lymphoma and rheumatoid arthritis, a type of blood cancer. Rituxan's annual sales is worth 8 trillion won (US$7.2 billion), ranking 4th in global drug sales last year. Of the global market, the U.S. market alone is worth about 5 trillion won (US$4.5 billion).

Truxima became the first Rituxan biosimilar sold in the U.S. Due to the nature of biosimilars, the earliest-launching “first mover” tends to dominate the market, which puts Truxima in an advantageous position for sales compared to its competitors. Sales in the U.S. will be handled by local distributor Teva. Once the drug prices and sales network are established, the drug will be available for purchase in the first half of next year at the earliest.

Truxima received approval in Europe last year and has been successful in sales.