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Bioepis gets European approval to sell Ontruzant

Mar 06,2019
Korean biopharmaceutical firm Samsung Bioepis said Tuesday it has won approval from European authorities for the sale of mass dosages of its biosimilar drug Ontruzant.

The European Medicines Agency (EMA) accepted Samsung Bioepis’ application to sell the 420 milligrams biosimilar product referencing Switzerland-based Roche Holding’s Herceptin, also known as Trastuzumab, the company said.

The 150 milligrams product was approved by the EMA in Nov. 2017, which allowed Samsung Bioepis to sell the product in 28 European Union member states, as well as Norway, Iceland and Liechtenstein, according to the company.

“There is demand for both 150 milligrams and 420 milligrams products in Europe,” a company official, who asked not to be named, said. “We expect to provide more treatment opportunities for patients by expanding our product portfolio.”

Samsung Bioepis 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 are provided to customers at discounts. Biosimilars are officially approved copycat medicines developed after patents for the original biopharmaceuticals expire.


Yonhap