Advanced Knowledge and Skills of Originator and Biosimilar Biologics: For Health Care Providers

Module 1 - Understanding Biologics and Biosimilars

Learning Objectives:

1. Describe biologic medications, including how they are manufactured and how they are used in clinical practice

2. Describe biosimilar biologics, how they differ from generics and how they are used in clinical practice

3. Define inherent variability and comparability.

4. Discuss the requirements and process for demonstrating comparability of biosimilar biologics

5. Describe why biosimilar medications are important now

Module 2 - Regulatory Approval Process

Learning Objectives:
1. Describe the approval process for biosimilars in Canada, including general considerations for new drugs and special considerations for biologics

2. Compare and contrast the approval process for biosimilar biologics and originator biologics

3. Examine the safety and efficacy of biosimilars

4. Describe pharmacovigilience and adverse reporting mechanisms for originator and biosimilar biologics in Canada

5. Describe the authorization of specific indications for biosimilars

6. Distinguish interchangeability and switching in relation to biosimilars

Module 3 - Instilling confidence in patients about their care plan & ethical considerations

Learning Objectives:

1. Develop an awareness of ethics and ethical principles

2. Appreciate the ethical issues related to biosimilar biologics

3. Understand the factors that contribute to a trustworthy clinician-patient therapeutic relationship

4. Identify the communication skills needed to cultivate a trusting clinician-patient relationship, including with patients from diverse communities

5. Consider the broader structural influences on therapeutic trust within the context of biosimilar biologics

Module 4 - Discussing Biosimilars with your Patients

Learning Objectives:
1. Understand how patient expectations and beliefs impact treatment changes

2. Describe strategies to elicit patient perspectives on switching medications

3. Apply proven principles of patient-physician communication and motivational interviewing to discussions about switching medications

4. Identify strategies to create a positive mindset in patients for switching medications