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).