Ontruzant (trastzumab) is the first biosimilar in Europe to Roche’s Herceptin.
Herceptin is an antibody-based drug from Roche/Genentech that is approved for the treatment of early breast cancer, metastatic breast cancer and metastatic gastric cancer. The first biosimilar to Herceptin, developed by Korean biologics company Samsung Bioepsis, a joint venture between Samsung BioLogics and Biogen established in 2012, received a positive opinion from the European Medicines Agency in September 2017 and approval from the European Commission a month later.
Ontruzant (trastzumab) was recently launched in the UK and is being marketed by MSD, which is known in North America as Merck and Co. MSD has a commercialization agreement with Samsung Bioepsis.
The biosimilar was approved based on the results of clinical studies, which showed that it is highly similar to Herceptin (trastuzumab) with respect to its structure, biological activity and efficacy, safety and immunogenicity profile.
It 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,” he added.
Samsing Bioepsis announced in December 2017, that the US Food and Drug Administration accepted its Biologics License Application (BLA) under the 351(k) pathway for its biosimilar candidate referencing Herceptin®i (trastuzumab), which the company refers to as SB3.