The arrival of biosimilar monoclonal antibodies in oncology: clinical studies for trastuzumab biosimilars.

ABSTRACT: The monoclonal antibody trastuzumab (Herceptin®), which targets the human epidermal growth factor receptor 2 (HER2), is approved for the treatment of early breast and advanced breast and gastric cancer in which HER2 is overexpressed. Several biosimilar versions of trastuzumab are expected to enter the European market over the course of 2018 and 2019. The biosimilar development pathway consists of a comprehensive comparability exercise between the biosimilar candidate and the reference product, primarily focussing on data from analytical studies. Clinical studies for biosimilar candidates follow a different design to those for a new biological, as the aim is not to independently establish clinical benefit, but to confirm biosimilarity between the two agents. The different trastuzumab biosim

SUBMITTER: Barbier L 

PROVIDER: S-EPMC6738325 | biostudies-literature | 2019 Jul

REPOSITORIES: biostudies-literature