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Samsung Bioepis seeks approval for biosimilar of cancer drug in Europe

[THE INVESTOR] Samsung Bioepis’ biosimilar of Roch’s blockbuster cancer drug Herceptinis has been submitted for regulatory review in Europe, the firm said on Oct. 4.

According to Samsung’s biotech unit, European Medicines Agency has accepted for review its application to sell SB3, its biosimilar of Herceptin.

“If SB3 receives an approval in Europe, it will contribute to improving the quality of female patients’ lives as treatment opportunities through breast cancer drug can be enhanced,” the firm’s CEO Ko Han-seung said.




SB3 is the first anti-cancer drug that was submitted for regulatory approval in Europe by Samsung Bioepis.

Swiss-based Roche recorded sales of the drug totaling $3.49 billion in the first half of 2016.

By Park Han-na (hnpark@heraldcorp.com)
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