Biosimilarity and Interchangeability: Principles and Evidence: A Systematic Review
Ross A McKinnon, Matthew Cook, Winston Liauw, Mona Marabani, Ian C Marschner, Nicolle H Packer, Johannes B Prins
BioDrugs: clinical immunotherapeutics, biopharmaceuticals and gene therapy | ADIS INT LTD | Published : 2018
BACKGROUND: The efficacy, safety and immunogenicity risk of switching between an originator biologic and a biosimilar or from one biosimilar to another are of potential concern. OBJECTIVES: The aim was to conduct a systematic literature review of the outcomes of switching between biologics and their biosimilars and identify any evidence gaps. METHODS: A systematic literature search was conducted in PubMed, EMBASE and Cochrane Library from inception to June 2017. Relevant societal meetings were also checked. Peer-reviewed studies reporting efficacy and/or safety data on switching between originator and biosimilar products or from one biosimilar to another were selected. Studies with fewer tha..View full abstract
Administrative and medical writing support was provided by Ms Donna Bartlett (Allori Pty Ltd, Australia) and Dr. Anja Becher (Sydney, Australia), and was funded through Medicines Australia with specific support from the Australian affiliates of AbbVie, Amgen, Eli Lilly, Janssen, Novo Nordisk, Roche and Sanofi. The sponsors were given the opportunity to review the final version of the article for accuracy pertaining to sponsored products and compliance with individual processes; however, they did not influence the content. The authors were responsible for all content and editorial decisions and received no honoraria related to the development of this manuscript.