Biotech Values

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Celltrion: the Korea Food and Drug Administration (KFDA) approved the first mAb biosimilar of Remicade

A local biopharmaceutical company has won approval to produce the world’s first antibody biosimilar, paving the way for it to enter a new market with lucrative potential.

Celltrion announced yesterday that the Korea Food and Drug Administration (KFDA) approved its product Remsima after seven years of clinical tests and development.

Remsima is a biosimilar version of U.S. Merck’s Remicade, a globally renowned medication for rheumatoid arthritis.

Celltrion is currently awaiting approval of the same product from the European Medicines Agency (EMA). By the end of this year, it hopes to win approval for the drug from around 100 countries.

http://koreajoongangdaily.joinsmsn.com/news/article/article.aspx?aid=2956710&cloc=joongangdaily%7Chome%7Cnewslist2