Gastroenterology Primer on Biosimilars


Supportive 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), with review and input from Usha Chauhan (NP, McMaster University), to provide a nursing perspective. This report details the basic science, management and regulatory pathways, legal perspectives and recent clinical data on biosimilars. It is informed by various CARE™ faculties and recent biosimilar news.

This Gastroenterology Biosimilars Primer is written as of May 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


Usha Chauhan, NP
Supportive CARE™ 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