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jq1234

07/24/12 12:48 PM

#145958 RE: jq1234 #140287

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

DewDiligence

02/12/13 9:24 PM

#156902 RE: jq1234 #140287

According to Celltrion/HSP information you furnished, there are eight FoB’s in the collaboration: Remicade, Herceptin, Rituxan, Enbrel, Erbitux, Synagis, Humira, and Avastin: see page 9 of https://dl.dropbox.com/u/72115812/celltrion_kdb_report_04JAN2012.pdf .

DewDiligence

06/28/13 2:34 PM

#163148 RE: jq1234 #140287

Biosimilar infliximab (Remicade)…Celltrion is partnered with HSP for this product.

Apparently, these companies are no longer partnered on Remicade insofar as they received distinct biosimilar approvals from the CHMP today (#msg-89473615). Unless Celltrion and HSP have some kind of profit-sharing agreement pertaining to both drugs, they would seem to be competitors rather than partners in this instance.