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University of Toronto

Foundations of Originator and Biosimilar Biologics: for Patients and Caregivers

University of Toronto via edX


- This course aims to provide knowledge and skills for patients on the topic of biosimilars, a class of biologic drugs or medical therapies that are highly similar to an existing originator medication that is off patent.

- Biosimilars represent a rapidly growing area in pharmaceutical development, treatment options, and patient care that require an evidence-informed implementation approach.

- As awareness and use of biosimilars increases globally, this course will provide information and guidance to support patient understanding of the effective and safe use of biosimilars in clinical settings.

- The course will focus on enhancing knowledge and skills for patients and caregivers related to biosimilars.

- The course will utilize a modular approach to provide content that is accessible and informative to all learners, and provide an introduction to biosimilar medications including what they are, regulatory processes, access, and discussing biosimilars with your healthcare provider.


Module 1 - Understanding Biologics and Biosimilars

Learning Objectives:
1. Describe biologic medications, including how they are made and how they are used in clinical practice

2. Describe biosimilar biologics, including how they differ from other generic medications and why they are used in clinical practice

3.Compare and contrast biologic and biosimilar medications

Module 2 - Regulatory Approval Process

Learning Objectives:
1. Describe Health Canada's approval process for biosimilar biologic use and sale in Canada

2. Describe the safety and monitoring activities of biosimilar biologics, including the similarities between originator and biosimilar biologics

3. Explain the purpose of and the steps to find a product monograph on biosimilars

4. Describe the indications for originator and biosimilar biologics

5. Distinguish between interchangeability and switching between originator and biosimilar biologics.

Module 3 - Patient Access

Learning Objectives:
1. Understand the significance and use of biosimilars in certain people livin with diseases

2. Describe how biosimilar biologics are paid for in Canada

3. Describe Patient Support Programs (PSPs) and their role in helping patients coordinate cost and administration of biosiilar biologics

4. Describe the administration of biologics and possible changes when a patient is switched to a biosimilar

Module 4 - Discussing Biosimilars with your Health care Provider

Learning Objectives:
1. Explain how biosimilar use is monitored in Canada with respect to side effects and adverse drug reactions

2. Describe common facts about biosimilar biologics to become more familiar with them

3. Gain confidence in talking to your healthcare provider and others about biosimilar biologics

Taught by

Kathy Vu


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