Biosimilars: State of Clinical and Regulatory Science

Authors

  • Agnes Victoria Klein Health Canada, Biologics and Genetic Therapies Directorate
  • Jian Wang Clinical Evaluation Division - Haematology/Oncology Centre for the Evaluation of Radiopharmaceuticals and Biotherapeutics, Biologics and Genetic Therapies Directorate Health Canada
  • Brian G. Feagan Epidemiology and Biostatistics Western University London Ontario
  • Mark Omoto QuintilesIMS Toronto, ON, Canada

DOI:

https://doi.org/10.18433/J3VK90

Abstract

On May 12, 2017, various issues and challenges associated with biologics were discussed during a session of the annual joint conference of Canadian Society for Pharmaceutical Sciences and Canadian Chapter of Controlled Release Society at Hyatt Regency Hotel, Montréal, QC, Canada.  An update on the Canadian regulatory guidelines for biosimilars was given, followed by viewpoints expressed by regulatory, academic and industry scientists.  Topics of discussion included: reference biologic drug, clinical considerations, immunogenicity, extrapolation and clarification of terminology, product monograph, international collaboration, switching and interchangeability, naming conventions, clinical and non-clinical evaluation, authorization of indications, statistical equivalence, the nor-switch study and biologics marketplace.

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Author Biography

Agnes Victoria Klein, Health Canada, Biologics and Genetic Therapies Directorate

Senior Medical Advisor

Director General's Office

Biologics and Genetic Therapies Directorate

Health Products and Food Branch

Health Canada

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Published

2018-01-09

How to Cite

Klein, A. V., Wang, J., Feagan, B. G., & Omoto, M. (2018). Biosimilars: State of Clinical and Regulatory Science. Journal of Pharmacy & Pharmaceutical Sciences, 20(1), 332–348. https://doi.org/10.18433/J3VK90

Issue

Vol. 20 (2017): Pages 319-452

Section

Reports

License

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