Celltrion’s biosimilar receives FDA approvalCelltrion said Thursday its Truxima biosimilar received U.S. Food and Drug Administration (FDA) approval Wednesday local time for sales in the domestic U.S. market.
The approval was issued seven weeks after the 16 members of the Oncologic Drugs Advisory Committee (ODAC) of the FDA voted unanimously for Truxima to be approved for use in the United States, which has been moving to encourage cheaper medicines.
Truxima is used in the treatment of a number of diseases in adult patients, including rheumatoid arthritis and non-Hodgkin’s lymphoma, a type of leukemia. The biosimilar references a pharmaceutical developed by Roche of Switzerland.
The original drug sells under the brand name MabThera in Europe and Korea and Rituxan in the United States. This is the first time a Rituxan biosimilar has been granted U.S. FDA approval. The market for Rituxan in the United States is around 5 trillion won ($4.4 billion), accounting for 56 percent of the revenue for the drug around the world.
“As part of the FDA’s Biosimilars Action Plan, we’re advancing new policies to make the development of biosimilars more efficient and to enable more opportunities for biosimilar manufacturers to make these products commercially successful and competitive,” said FDA Commissioner Scott Gottlieb, in a statement. “Our goal is to promote competition that can expand patient access to important medicines.”
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 became available for purchase in 18 European countries in June after gaining regulatory approval in February last year. According to market researcher Iqvia, Truxima captured 32 percent share of the Rituxan market in Europe as of the second quarter.
Truxima is the second biosimilar product Celltrion is selling in the United States, the biggest pharmaceutical market in the world.
In 2016, Remsima was put on sale by Pfizer in the United States under the name Inflectra. Remsima is an identical copy of Janssen Biotech’s Remicade and is effective in treating various diseases, from rheumatoid arthritis to Crohn’s disease.
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