First Trastuzumab Biosimilar Launches in Europe

Merck, operating under the trade name MSD in the European Union, announced today that it has launched Samsung Bioepis’ biosimilar trastuzumab, Ontruzant, in the United Kingdom.

The biosimilar, also known as SB3, references Roche’s Herceptin, and is approved to treat early breast cancer, metastatic breast cancer, and metastatic gastric cancer. The brand-name Herceptin, approved in the European Union in 2000, is among the top-selling drugs in the global marketplace, having earned $6.75 billion in sales in 2016. Until today, the reference drug has remained unchallenged by biosimilar competition in Europe.

Mark Verrill, MA, MB, FRCP, head of the department of medical oncology at the Newcastle upon Tyne Hospitals National Health Service (NHS) Foundation Trust, said in a statement, “This is good news for so many cancer patients and the NHS. The launch of biosimilar trastuzumab provides a high-quality treatment alternative for patients, while offering significant potential savings for the NHS. The biggest category of medicines in oncology is monoclonal antibodies, and the introduction of biosimilars such as trastuzumab could provide a substantial cost saving.”

Denise Blake, MPharm, the senior lead clinical pharmacist at Newcastle Hospitals, added that, while the introduction of the biosimilar into the NHS has the potential to produce a significant cost savings to the health system, "Close collaboration between oncologists, pharmacists and nursing staff is required to ensure a seamless introduction into routine clinical practice."

The European Commission granted a marketing authorization for Ontruzant in November 2017, allowing the biosimilar to be sold in the European Union and the European Economic Area (comprising Norway, Iceland, and Liechtenstein). The authorization followed a September 2017 positive opinion issued by the European Medicines Agency’s Committee for Medicinal Products for Human Use.

Samsung Bioepis has also filed for US regulatory review for the drug; in December 2017, the company announced that it has submitted a Biologics License Application for the biosimilar to the FDA. If eventually approved, the drug will be commercialized in the United States by Merck. Earlier this week, the biosimilar launched in the Republic of Korea, where it is commercialized by Daewoong Pharmaceutical under the brand name Samfenent.