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Korean Drug Ministry releases more biosimilar approval results in English

The South Korean Ministry of Food and Drug Safety this week released an English version of the results of its latest approval evaluation of Korea-made biosimilar drugs.

The ministry started to offer the English versions in August with the aim of helping the companies expedite approval in other countries.

The recent English-language disclosure were of Samsung Bioepis’ two biosimilars for treating rheumatoid arthritis -- Brenzys and Renflexis.

Brenzys is a biosimilar referencing Amgen’s top-selling drug Enbrel (etanercept) while Renflexis is based on Johnson & Johnson’s blockbuster treatment Remicade (infliximab).

Biosimilars refer to cheaper, near-replicas of biologic drugs that have lost patent protection. Multiple companies around the world have been developing biosimilars in line with the approaching patent expiry of some of the world’s top-selling biologics.

In August, the Korean Drug Ministry released English-language approval evaluation results of Celltrion’s two biosimilar drugs, Remsima and Herzuma. The former references Remicade while the latter references Roche’s Herceptin (tastuzumab).

The ministry said it further plans to release its approval evaluation of Celltrion’s Truxima, based on Roche’s lymphatic cancer treatment Rituxan (rituximab), in English. Truxima obtained domestic sales approval in November as the fifth locally-made biosimilar to debut here.

“We will continue to open up the results of our approval evaluation of Korean biosimilars to aid the launch of the drugs in global markets,” the ministry said in a statement.

The Korean Drug Ministry is currently chairing the International Pharmaceutical Regulators Forum, a body consisting of the world’s major drug regulators including the US Food and Drug Administration and the European Medicines Agency.

The Drug Ministry’s English-language approval documents on Korean biosimilars can be viewed by clicking “Pharmaceutical Information” under the “Category Information” tab at

By Sohn Ji-young (