This course is sponsored by an unrestricted education grant from Merck Canada Inc.
This series is designed to give learners a better understanding of these emerging products and their place in the biologic-based drug therapies. Topics covered include similarities between biosimilar and innovator biological products, evolving clinical evidence of their use, their economic impact, and the important role of pharmacists to support a viable biosimilar market in Canada among others. At the end of the session, learners will be equipped with the knowledge and tools to engage and inform eligible and appropriate patients in a conversation to start or transition to a biosimilar product.
This course is CCCEP accreditated for 2.0 CEUs (file # 1092-2018-2537-I-P). Accreditation expiry 2019-07-27.
There are four parts in the Biosimilars Course. This will be followed by an assessment with 13 multiple choice questions with a passing grade of 70%. Multiple attempts will be permitted.
Part 1: Preclinical Requirements for Approval and Development: The Science of Quality by Design by Ismael Samudio.
Explain how biosimilarity is exemplified for a protein biologic
Explain the relevance of each biosimilarity parameter to the therapeutic characteristics of the protein biologic
Part 2: Biosimilars: Research & Clinical Update – Dr. John M. Esdaile
Provide an overview of biosimilars research and clinical updates
Review current data on “switching” from originators to their biosimilars
Provide insights on “real world” clinical experience with biosimilars
Provide summary of key clinical perspective “takeaways”
Part 3: Where the Biosimilars Rubber Hits the Road – With Patients – Cheryl Koehn
Provide an overview of biosimilar policies in the EU, USA and Canada
Explaining and Mitigating the biosimilar “Nocebo” effect
Uncovering the societal benefits of biosimilars
The biosimilars transition conversation – key questions and information pieces patients want
Part 4: Pharmacist Opportunities with Biosimilars – Derek Desrosiers
Understand regulator interchangeability recommendations in Canada and the USA
Understand possible implications for consideration when switching from a biologic to a biosimilar
Know that some evidence exists to support interchangeability in specific circumstances
Understand the steps to take in making a switch and the role of the pharmacist in the interchangeability process