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Samsung Bioepis seeks gov’t approval for cancer biosimilar

By 황유미
  • Published : Sept 20, 2016 - 11:31
  • Updated : Sept 20, 2016 - 14:19
[THE INVESTOR] Samsung Bioepis has sought approval from the Ministry of Food and Drug Safety for its Herceptin biosimilar SB3, according to news reports on Sept. 19.

SB3’s reference drug Herceptin is the sixth most-prescribed breast cancer medicine that has sold over US$6.8 billion worldwide.

Before filing its approval application on Sept. 13, it also sought confirmation from the Intellectual Property Trial and Appeal Board that it was not infringing the patent of the original drug. The decision is yet to be announced.



This will be the first biosimilar for cancer treatment and the third biosimilar to be launched by the bio research and development company, following Benapali/Brenzys and Flixaby/Renflexis, both autoimmune disease drugs.

The biopharmaceutical affiliate of Samsung is also planning to seek approval from the European Medicines Agency, according to industry sources. The company has not officially confirmed the plan.

By Hwang You-mee (glamazon@heraldcorp.com)