Celltrion’s Truxima to go on sale in U.S. on Monday

Celltrion Healthcare will launch sales of Truxima, a biosimilar referencing blood cancer cure Rituximab, in the United States on Monday.

Biosimilars, according to the FDA, are biological products that are approved based on proof that they are highly similar to other FDA-approved products. The drugs have no clinically meaningful differences in terms of safety or effectiveness from the reference product, but they cost less.

Truxima is a biosimilar referencing Rituximab, a cure for non-Hodgkin’s lymphoma and chronic lymphocytic leukemia - both cancers that develop from white blood cells. It is sold under the name Rituxan by Biogen, Genentech in the United States and Hoffmann-La Roche in Canada and Europe. Its patent expired in 2016.

Celltrion’s Truxima is the first Rituximab biosimilar to start sales in the United States, which accounts for 60 percent of the global Rituximab market. Truxima became the first FDA-approved biosimilar to Rituximab last May. According to 2018 data from Iqvia, a U.S. research firm specializing in health information, the U.S. market for Rituximab is worth 5 trillion won a year ($4.3 billion).

Israel-based Teva Pharmaceutical will be in charge of Truxima’s marketing and sales in the United States. The company had signed a deal with Celltrion in October 2016 to commercialize Truxima in the United States and Canada. Teva is already selling blood cancer cure Bendeka in the U.S. market, and Celltrion said its existing distribution channels would benefit sales activities for Truxima.

Truxima is currently being sold across Europe, South America and Asia. During the year’s second quarter, the biosimilar accounted for 38 percent of the European Rituximab market. In the United States, Truxima is Celltrion’s second biosimilar to hit shelves. Remsima, a biosimilar identical to Janssen Biotech’s Remicade, started selling in the country in late 2016.

“We are pleased to announce the launch of the first Rituximab biosimilar, Truxima, with our marketing partner Teva in the U.S.” said Kim Hyoung-Ki, vice chairman at Celltrion Healthcare. “We believe that the introduction of Truxima into the U.S. market will contribute to address the unmet needs of U.S. patients as well.”

BY SONG KYOUNG-SON [song.kyoungson@joongang.co.kr]