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Bioepsis biosimilar cancer drug sells in Europe

Mar 10,2018
Korean biopharmaceutical firm Samsung Bioepis said Friday its biosimilar cancer drug Ontruzant has begun selling in Britain following approval from a European regulator.

Global health care company MSD has begun distributing the biosimilar that references Switzerland-based Roche Holding’s Herceptin, also known as Trastuzumab, in the country, Samsung Bioepis said.

In November 2017, the European Commission (EC) accepted Samsung Bioepis’ application to sell the drug designed to treat early breast cancer, metastatic breast cancer and metastatic gastric cancer. EC’s approval opened the way for Ontruzant to be sold in 28 EU member states as well as Norway, Iceland and Liechtenstein, according to the company.

With the marketing authorization of Ontruzant, Samsung Bioepis became the first South Korean drugmaker to receive European approval for a biosimilar referencing Herceptin.

Samsung Bioepis said it has set an industry record by obtaining regulatory approval for four biosimilars - the others being Benepali, Flixabi and Imraldi - in just two years.

The company was established in 2012 in a joint venture between Samsung BioLogics and Biogen. Samsung BioLogics is a biopharmaceutical unit of South Korea’s top conglomerate, Samsung Group.

The market for biosimilars has grown in recent years as they can be sold to customers at a discount. Biosimilars are officially approved copycat medicines developed after patents for the original biopharmaceuticals expire.


Yonhap