EMA Recommends Approval of Herceptin Biosimilar

Samsung Bioepis, a biopharmaceutical company, announced on Sep. 15, 2017 that the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion on Ontruzant (trastuzumab), a biosimilar candidate referencing Roche’s Herceptin (trastuzumab), for treating early breast cancer, metastatic breast cancer, and metastatic gastric cancer. Herceptin is one of Roche’s top-selling drugs with 2016 sales of CHF 6.78 billion (US$7.06 billion).

The CHMP’s positive opinion will now be referred to the European Commission, which will decide whether to grant marketing authorization. If granted, Ontruzant will be commercialized in the European Union by MSD, known as Merck & Co. in the United States and Canada.

“We are proud to see Ontruzant become the first trastuzumab biosimilar recommended for approval in Europe, where breast cancer remains the most common form of cancer affecting women. If approved, we hope [it] will play an important role expanding patient access to trastuzumab across the region,” said Christopher Hansung Ko, president & CEO of Samsung Bioepis, in a company press release.

Source: Samsung Bioepis