title: New frontiers in oncology: biosimilar monoclonal antibodies for the treatment of breast cancer.
abstract: Trastuzumab is a highly successful monoclonal antibody (mAb) that has been used primarily for the treatment of HER2-positive breast cancer. Because of its success and its impending patent expiry in Europe in 2014, a number of copy versions of trastuzumab have been developed and are currently undergoing a comparability exercise for marketing authorization. Although biosimilar products have been approved in Europe since 2006, including two biosimilar mAbs of infliximab approved in 2013, the use of mAbs such as trastuzumab in the cancer setting has raised a number of new concerns. The requirements for the approval of biosimilar mAbs published by the EMA will be discussed and examined in the context of trastuzumab biosimilars to highlight potential controversies.
authors.affiliation: Department of Gynecology and Obstetrics, Agaplesion Markus Hospital, Wilhelm-Epstein-Str 4, 60431 Frankfurt am Main, Germany.
authors.forename: Marc
authors.initials: M
authors.lastname: Thill
mesh_terms: D000818:Animals; D000911:Antibodies, Monoclonal / Q000627:therapeutic use; D061067:Antibodies, Monoclonal, Humanized / Q000627:therapeutic use; D000970:Antineoplastic Agents / Q000627:therapeutic use*; D059451:Biosimilar Pharmaceuticals / Q000627:therapeutic use*; D001943:Breast Neoplasms / Q000188:drug therapy* / Q000473:pathology; D017277:Drug Approval; D015195:Drug Design; D005060:Europe; D005260:Female; D006801:Humans; D000069285:Infliximab; D000068878:Trastuzumab
chemical_list: D000911:Antibodies, Monoclonal; D061067:Antibodies, Monoclonal, Humanized; D000970:Antineoplastic Agents; D059451:Biosimilar Pharmaceuticals; D000069285:Infliximab; D000068878:Trastuzumab
keywords: CT-P6; Herceptin; biosimilar; biosimilar antibody; breast cancer; monoclonal antibody; trastuzumab