Advanced Knowledge and Skills of Originator and Biosimilar Biologics: For Healthcare Providers

- This course aims to provide education and training, as well as advance knowledge and skills, for health care professionals 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 the effective and safe use of biosimilars in clinical settings among health care providers.

- The course will focus on enhancing knowledge and skills to affect change in attitude and behaviour of health care providers related to biosimilars.

- The course will utilize a modular approach to provide content that is accessible and informative to all learners, including pharmacists, physicians, nurses, students and young professionals, industry, and policy-makers.

- This course may be eligible for continuing education credits through professional accreditation bodies.

- The course will also provide learners with opportunities to develop skills in each of these knowledge areas, with the overall aim of improving patient-provider communication and perceptions of biosimilar use and establishing a consistent foundation among health care providers for communicating with patients about biosimilar treatment.

- This course will build off of the material in BSS101 to provide advanced knowledge and skills related to use and implementation of biosimilar medications in clinical settings.

• Improve knowledge of biologic and biosimilar medicines

• Understand scientific and clinical evidence to support appropriate cost-effective application of biosimilars across oncology, rheumatology, gastrointestinal disease, and other medical conditions

• 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 to optimize patient care and wellness

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

3 Pharmacovigilence

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

3. Describe how biosimilar use is monitored in Canada with respect to side effects and adverse drug reactions

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

3 Barriers and enablers for successful biosimilar implementation

Learning Objectives:

1. List common questions that you should be prepared to discuss with your patients about biosimilars

2. Describe barriers and enablers to successful biosimilar implementation

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