Foundations in Biosimilars and Biologics

- 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 present 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

1 Biologic medications
2 Biosimilar medications
3 Producing biologic and biosimilar medications
4 Inherent variability
5 Comparability

Learning Objectives:
1. Describe biologic medications, including how they are made and how they are used in clinical practice
2. Describe biosimilar medications including how they differ from biologics and other generic medications and why they are used in clinical practice
3. Compare and contrast biologic and biosimilar medications

Module 2 - Regulatory Approval Process

1 Regulatory Approval of Biosimilars
2 Drug Indications

Learning Objectives:
1. Describe the approval process for biosimilars in Canada
2. Describe situations where biosimilars may and may not be used in place of biologics

Module 3 - Patient Access

1 Biosimilar use in clinical practice
2 Access and coordination of care

Learning Objectives:
1. List the advantages and disadvantages of biosimilars in clinical practice
2. Describe Patient Support Programs (PSP) and their role in helping patients coordinate cost and administration (injecting) biosimilars
3. Describe how biosimilars are funded in Canada

Module 4 - Discussing Biosimilars with your HCP

1 Monitoring
2 Communicating with your healthcare provider

Learning Objectives:
1. List common questions you should ask your healthcare providers (doctors, nurses and pharmacists) about biosimilars
2. Describe how biosimilar use is monitored in Canada with respect to side effects and adverse drug reactions

Additional Course Resources

• Currently marketed biosimilars and their reference biologics (link to Health Canada drug database)
• pCOBI infographics/brochures
• Videos/blogs (ex. From patient reps)
• Links to provincial / territorial resources
• Links to additional resources