Aprogen Pharmaceuticals said Wednesday that the company’s NI-071 (Original: Remicade), a biosimilar that treats autoimmune diseases, has won a sales approval from Japan’s Ministry of Health, Labour and Welfare.
Two Japanese companies, Nichi-Iko Pharmaceutical and Yakuhan Pharmaceutical, which have partnered with Aprogen 에이프로젠, will be selling the treatment.
“Aprogen has become the third company in Korea to receive biosimilar sales approval in advanced markets following Celltrion 셀트리온 and Samsung Bioepis 삼성바이오에피스,” a company official said. “Although we started later than the two companies, we will increase market share based on competitive price.”
Japan’s Remicade market is known to be worth 1 trillion won ($876.4 million).
The company also plans to proceed and complete phase 3 clinical trials in the U.S. and apply for sales approval in America next year.