Celltrion receives marketing approval of its third biosimilar in Korea

2016.11.17 17:27:46 | 2016.11.17 17:28:47

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Celltrion Inc. announced on Wednesday it has received marketing approval of its biosimilar Truxima (rituximab) from the Ministry of Food and Drug Safety, adding the third antibody biosimilar to its commercial lineup.

Celltrion received marketing approval of Remsima in July 2012 and Herzuma in January 2014 in Korea.

Truxima is indicated for the treatment of patients with non-Hodgkin lymphoma, chronic lymphocytic leukemia and rheumatoid arthritis. Truxima¡¯s reference drug is Rituxan developed by Roche, is a blockbuster drug whose sales reached $7.3 billion ($6.2 million won) last year, the second¡¯s best-selling biologic behind Humira. Global pharmaceutical companies such as Amgen, Pfizer and Boehringer Ingelheim are racing to develop a biosimilar version of Rituxan, but Celltrion is currently gaining the upper hands in the market.

An official at Celltrion said "many multinational pharmaceutical companies tried to develop rituximab but they had to terminate projects due to technical obstacles. We will do utmost efforts to deliver Truxima proven equivalent in efficacy and safety to the original drug to patients as soon as possible.¡±

On Thursday, shares of Celltrion closed at 103,900 won, down 1.14 percent, or 1,200 won, from the previous session.

By Shin Chan-ok

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