S. Korea approves sales of domestic anti-cancer biosimilar

By Park Sae-jin Posted : November 17, 2016, 15:18 Updated : November 17, 2016, 15:45

[Courtesy of Celltrion]


South Korea's drug safety agency endorsed sales of a home-made anti-cancer biosimilar at home Thursday, paving the way for Celltrion to seek approval and shipment abroad.

Celltrion, one of the country's leading biopharmaceutical firms, was allowed to sell its new anti-cancer biosimilar, said the Ministry of Food and Drug Safety. A biosimilar is a biopharmaceutical drug created to have similar active properties to a licensed drug.

The company has released three types of biosimilars, including Truxima. "We will concentrate on promoting Truxima, a drug acknowledged by its effectiveness and stability through clinical demonstration," a Celltrion official said.

Truxima is a biosimilar of Rituximab, an antibody primarily found on the surface of immune system B cells. Because the antibody destroys B cells, it is used to treat diseases caused by dysfunctional or excessive immune cells such as leukemia, transplant rejection and autoimmune disorders.

Rituximab is listed by the World Health Organization to be one of the essential medicines.

Celltrion has applied for the permission of articles to the European Medicines Agency in October last year. Many experts believe the drug ministry's decision could affect approval in Europe. The company plans to seek licenses from the US Food and Drug Administration at the first half of next year.

Aju News Park Sae-jin = swatchsjp@ajunews.com
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