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First biosimilar of Enbrel may come up soon
by Eui Kyoung Yoon (ekyeun@dreamdrug.com)
Published : Jul 16, 2014 15:18:18
Hanwha retries to get marketing approval for its own biosmiliar of Enbrel. Ministry of Food and Drug Safety (MOFDS) said on July 14 that Hanwha sent its new drug application for its biosimilar of Enbrel again.

Hanwha sent its marketing application back in 2012, but it voluntarily cancelled the application after finding that the application review period would be longer than 1 year. It is known that the only issue was a standard test method.

An official of the MOFDS said, “If there is no problem with the standard test method, the application review can be completed in three months.”

It took only six months until Remsima and Herzuma got approved by the MOFDS.

Hanwha plans to market its biosimilar globally. It currently looks for global marketing partners in Europe where Enbrel goes off patent in 2015.
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