Gastroenterology Primer on Biosimilars

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CARE™ Primer on Biosimilars

The primer offers information on biologics and biosimilars, with a focus on the basic science, regulatory pathways, clinical data and implications, as well as legal perspectives. 

  • Biologic therapy has revolutionized the treatment of many gastroenterological disorders, and drastically improved patient outcomes.
  • Many biologic therapies used in gastroenterology have gone, or are going off patent, and competitive biosimilars are being introduced. 
  • Biosimilars not only have implications for specialty fields, but also for the general delivery of health care in Canada. 

What follows is a primer on biologics and biosimilars, updated to reflect a gastroenterological perspective. This educational report was created in conjunction with CARE™ Faculty Member Dr. John Marshall (McMaster University), and details the basic science, management and regulatory pathways, legal perspectives and recent clinical data on biosimilars. This report is also informed by various CARE™ faculties and recent biosimilar news.

This Gastroenterology Biosimilars Primer is written as of July 2018 and is subject to update and refinement. It is based upon a multi-disciplinary CARE™ Primer on Biosimilars (produced Fall 2017). For more information on CARE™ visit To access the comprehensive primer visit:

Contributing Authors

John K. Marshall, MD
CARE™ Gastroenterology Faculty
McMaster University


Scott Edwards, B.Sc., Pharm
Dr. H. Bliss Murphy Cancer Centre

Rob Laister, PhD
Princess Margaret Cancer Centre

Jason Thomas, RPh, B.Sc., Pharm
Juravinski Cancer Centre