Samsung Bioepis' Trastuzumab Biosimilar Gains European Marketing Authorization

Samsung Bioepis announced today that it has received the European Commission's (EC) marketing authorization for its biosimilar trastuzumab, SB3, for the treatment of early breast cancer, metastatic breast cancer, and metastatic gastric cancer. SB3 is the first biosimilar trastuzumab, referenced on Roche’s blockbuster Herceptin, to receive European regulatory approval.

The Korea-based Samsung Bioepis will market the drug as Ontruzant in the European Union, where the biosimilar will be commercialized by MSD (known in the United States and Canada as Merck). The EC’s marketing authorization applies to all 28 EU member states, as well as to the European Economic Area member states of Norway, Iceland, and Liechtenstein.

Christopher Hansung Ko, president and CEO of Samsung Bioepis, hailed today’s news, saying, “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.”

Today’s announcement follows a positive opinion for the biosimilar issued in September 2017 by the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use. It also marks the second regulatory approval for SB3 this month; earlier in November, the Korean Ministry of Food and Drug Safety granted Samsung Bioepis an approval to market the drug in the Republic of Korea under the name Samfenet.

The coming days could hold even more news for trastuzumab biosimilars; India-based Biocon announced today that the FDA has issued its aseptic drug product facility, audited between May and June 2017, an Establishment Inspection Report in relation to its current Good Manufacturing Practice inspection.

Biocon had previously withdrawn an application for its biosimilar trastuzumab (as well as a biosimilar pegfilgrastim) from the EMA after a French National Agency for Medicines and Health Products Safety inspection that found 35 deficiencies at the biosimilar developer’s Bangalore manufacturing plant. The FDA, too, had concerns about the facility, and delayed its decision on the drug shortly ahead of its Biosimilar User Fee Act date of September 3, 2017. The FDA is now expected to make a regulatory decision on Biocon’s trastuzumab biosimilar in early December.