UPDATE : Wednesday, March 21, 2018
Samsung Bioepis wins European sales approval for Ontruzant
  • By Lee Han-soo
  • Published 2017.11.20 10:48
  • Updated 2017.11.20 13:55
  • comments 0

The European Commission (EC) has granted marketing authorization for Samsung Bioepis’s Ontruzant, a trastuzumab biosimilar (Original: Herceptin), the company said Monday.

Ontruzant is used to treat patients with early breast cancer, metastatic breast cancer, and metastatic gastric cancer and is the first trastuzumab biosimilar to receive regulatory approval in Europe. Its original, Herceptin, is one of the world’s most purchased medicines with an annual sale of $6.9 billion in 2015.

“Breast cancer remains the most common form of cancer affecting women. We hope Ontruzant will play an important role expanding patient access to trastuzumab across the region,” said Ko Han-sung 고한승, CEO of Samsung Bioepis 삼성바이오에피스. “The company remains dedicated to advancing one of the industry's strongest biosimilar pipelines, through relentless process innovation and an uncompromising commitment to quality.”

MSD, which is known as Merck in the U.S. and Canada, will be in charge of commercializing the drug.

Ontruzant is the fourth biosimilar developed by Samsung Bioepis to receive EC marketing licenses. Samsung Bioepis has also received marketing approvals for Benepali (etanercept), Flixabi (infliximab) and Imraldi (adalimumab) in the EU.


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