The Korea Herald


Samsung Bioepis seeks approval for Humira biosimilar in Korea

By 이지윤

Published : Sept. 26, 2016 - 15:02

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[THE INVESTOR] Samsung Bioepis is seeking regulatory approval to sell its biosimilar drug referencing AbbVie’s top-selling rheumatoid drug Humira in South Korea.

According to industry sources on Sept. 26, the biopharma development unit of Samsung Group has recently submitted its application to the Korean authorities for the sales approval of its Humira biosimilar, called SB5.

Sources said the final approval could be granted in the first half of next year. 

A researcher works at a lab of Samsung Bioepis. A researcher works at a lab of Samsung Bioepis.

Humira, together with Enbrel and Remicade, are considered the top-selling biotech drugs that block chemicals linked to inflammation.

Samsung Bioepis is already selling its own biosimilar versions of Enbrel and Remicade in South Korea and Europe.

Adding to the three drugs, the company is also waiting for the approval for its SB3, a biosimilar for Roche’s breast cancer drug Herceptin, in South Korea.

By Lee Ji-yoon (