• Improve knowledge of biologic and biosimilar medicines

• Understand scientific and clinical evidence to support appropriate cost-effective application of biosimilars

• Address misconceptions regarding use of biosimilars

• Identify the benefits and significance of biosimilar use in clinical practice and across jurisdictions

• Discuss implications of biosimilar use for clinical practice and patient education

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