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S. Korean firms await approval to sell biosimilars in Europe

All News 10:11 July 19, 2016

SEOUL, July 19 (Yonhap) -- South Korean biotech drugmakers are waiting for a European regulator to approve sales of their biosimilars in the European market, in an effort to make inroads into one of the world's biggest markets for such drugs.

Samsung Bioepis Co., a unit of Samsung Group, said earlier this week that the European Medicines Agency (EMA) has accepted for review the company's application to sell its SB5, a biosimilar copy of AbbVie Inc.'s rheumatoid arthritis drug Humira.

"If approved, SB5 will join Benepali and Flixabi in Europe, which have already started to increase patient access to high-quality treatment options while driving down health care spending," said Christopher Hansung Ko, CEO of Samsung Bioepis, in a statement.

Ko said Samsung Bioepis "will continue to work hard to advance one of the industry's largest biosimilar pipelines."

Samsung Bioepis also applied the EMA to approve sales of its SB9, a biosimilar copy of Sanofi's diabetes drug Lantus.

Another Korean biosimilar maker, Celltrion Inc., had filed an application with the EMA in October last year to sell its Remsima, a biosimilar copy of Pfizer Inc.'s arthritis treatment Remicade.

An official at Celltrion said the company expects to win an approval as early as this year.

Biosimilars are officially approved copycat medicines developed after patents for the original biopharmaceuticals expire.


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