Ontruzant (trastzumab), Birleşik Krallık’ta MSD ve Samsung Bioepis Co arasında küresel biyobenzer geliştirme ve ticarileştirme anlaşması kapsamında onaylanan ilk üründür.
MSD has launched in the UK Europe’s first biosimilar to Roche/Genentech’s Herceptin, providing an alternative option for treating early breast cancer, metastatic breast cancer and metastatic gastric cancer.
Ontruzant (trastzumab) is the first product approved in the UK under a global biosimilars development and commercialisation agreement between MSD and Samsung Bioepis Co.
Clinical trials of the drug have shown it to be highly similar to Herceptin (trastuzumab) in terms of structure, biological activity and efficacy, safety and immunogenicity profile, the firm noted.
In early breast cancer, breast pathologic complete response rates were 51.7 percent with Ontruzant and 42 percent with Herceptin, while overall response rates were 96.3 percent and 91.2 percent, respectively.
Herceptin currently pulls in nearly $7 billion a year in sales. While pricing information for Ontruzant is not yet available, biosimilar versions are expected to be significantly cheaper than their reference products, and thus have the potential to generate substantial savings for healthcare providers.
“The launch of biosimilar trastuzumab provides a high-quality treatment alternative for patients, while offering significant potential savings for the NHS,” said Dr Mark Verrill, head of the Department of Medical Oncology at the Newcastle upon Tyne Hospitals NHS Foundation Trust.
“The biggest category of medicines in oncology is monoclonal antibodies and the introduction of biosimilars such as trastuzumab could provide a substantial cost saving.”
