Biosimilar Library
Written by: CDHF
Updated: April 17th, 2023
All of our biosimilars content in one place to help Inflammatory Bowel Disease (IBD) patients best understand the process of switching from a reference biologic to a biosimilar.
Both biologics and biosimilars have gone through rigorous standards for authorization by Health Canada, to which both have been found safe and effective for use in Inflammatory Bowel Disease (IBD).
CDHF knows having to change any kind of medication can be very stressful. CDHF’s Biosimilar library has many informative resources to help make your transition to your new medication seamless.
Explore Now:
- Transition Pathway Brochure: Get the Basic Facts
- IBD: Switching from a Biologic to a Biosimilar Animation
- What’s Health Canada Saying About Biosimilars?
What is a Biosimilar?
A biosimilar is a drug proven to be highly similar to a biologic drug that has been authorized for sale in Canada (known as the reference biologic drug).
Biosimilars have been approved by Health Canada based on a thorough comparison to a reference biologic drug and may enter the market after the reference biologic drugs’ patents and data protection has expired.
Biosimilar products first entered the Canadian market in 2009. Health Canada has already approved over 30 biosimilars, including some that are used to treat IBD (Crohn’s disease and ulcerative colitis): Inflectra (infliximab), Renflexis (infliximab), Avsola (infliximab), Hadlima (adalimumab), Idacio (adalimumab), Hyrimoz (adalimumab), Amgetiva (adalimumab) and Hulio (adalimumab).
Quality and Safety Around Biosimilars
To be approved in Canada, a biosimilar must be proven to have no clinically meaningful differences to the reference biologic. This means, studies of the biosimilar MUST show that there are no differences in outcomes for patients taking a biosimilar, compared to those taking a reference biologic drug. Rigorous standards for authorization by Health Canada mean that patients and health care providers can have the same confidence in the quality, safety and efficacy of a biosimilar.
Transitioning to a Biosimilar is Safe and Effective
Health Canada supports switching from a biologic to a biosimilar and considers that a one-time switch from a reference biologic drug to a biosimilar to be acceptable. Health Canada also recommends that the decision to switch be made by the physician/prescriber and patient, taking into account any policies of the relevant jurisdiction.
Transition Pathway Brochure: Get the Basic Facts
IBD: Switching from a Biologic to a Biosimilar
CDHF Talks: Your New Infusion Clinic ‘Not the Same but Very Similar’
Watch our CDHF Talks about biosimilar infusion clinics where Dr. Sean Pritchett, MD, Dr. Yvette Leung, Gastroenterologist, Athena Robitaille, BScN, RN, and Katelyn Syms, BScN, RN answer all of the questions you may have in regards to your new infusion clinic, and take you through a typical infusion at a real infusion clinic
What’s Health Canada Saying about Biosimilars?
What’s Health Canada Saying about Biosimilars: Infographic
Download the PDF What Health Canada is saying about biosimilars!
Other Relevant Resources:
- Health Canada Factsheet on Biosimilars
- Government of Canada | Guidance Documents: Information and Submission Requirements for Biosimilar Biologic Drug
- Canadian Originator Biologics Coalition
- Biosimilars Working Group
- Crohn’s and Colitis Canada
- Biosim Exchange
- CADTH Biosimilar Drugs | Fact Sheet
- Health Canada, Biosimilar Biologic Drugs in Canada | Fact Sheet
- Government of Canada | Guidance Documents: Information and Submission Requirements for Biosimilar Biologic Drug
