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22 biosimilars in clinical trials: watchdog

All News 12:29 April 06, 2017

SEOUL, March 6 (Yonhap) -- A total of 22 biosimilars are currently in clinical trials in South Korea, the country's drug watchdog said Thursday, amid an increase in generic versions of expensive drugs sold on the global market.

According to the Ministry of Food and Drug Safety, the biosimliars are undergoing varying phases of clinical trials, with nine of them by local pharmaceutical companies and seven by multinationals.

A biosimilar, which is almost an identical copy of an original or generic drug, is officially an approved copycat medicine developed after patents for the original biopharmaceuticals expire.

Among the biosimilars is "SAIT101," a biosimilar version of rituximab, by Archigen Biotech -- a joint venture formed by AstraZeneca and Samsung BioLogics, a biopharmaceutical unit of South Korea's top conglomerate Samsung Group. The drug is used in treatment for rheumatoid arthritis.

A number of local biosimilar manufacturers have recently made inroads into the overseas markets.

Most recently, the European Medicines Agency (EMA) accepted Celltrion Inc.'s application to sell its biosimilar to Roche's Mabthera. The antibody biosimilar is used in the treatment of a number of diseases, including rheumatoid arthritis and non-Hodgkin's lymphoma, a type of leukemia.


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