Biosimilars in Canada

If you can't answer these questions:
  • What is the difference between a generic and a biosimilar?
  • How does Health Canada view biosimilars?
  • What does “The Process is the Product” mean?
  • How will the introduction of biosimilars affect healthcare in Canada?

... do you know if the launch of Biosimilars will affect you?

Whether or not you represent a biologic product, continuing education in this fascinating and growing field in Canadian Healthcare is an opportunity for your professional development.

Patents protecting the first generation of biologics are beginning to expire, and the number of “biosimilar” drugs will continue to represent a greater share of the ~100 billion dollar global market. The path to market for these agents is different than that for generic, small molecule drugs. Production of biosimilars represents a broad set of challenges, with implications for the drug’s therapeutic value and safety profile.

The Advent of Subsequent Entry Biologics: Biosimilars in Canada is designed to help you better understand the world of SEBs and provide clarity in this emerging field where little is currently understood. Be on the cutting edge...

Biosimilars
Product Details

Course Name
Biosimilars in Canada

Category
Applied Skills

Package
2 modules in 1 binder
Number of pages: 255
Suggested number of hours of study: 26
Timeline: 6 months to complete the entire course

C.E. Units
2.6 (What is this?)

NOTE: Ce cours est disponible en anglais seulement

Registration

Register for this course using our secured online registration form

Price:
$1,062.00
Corporate Members: $531.00
Corporate Non-Members: $2,655.00

Information
For credit card payment process, shipping costs and return policy click here

Exam Information

Type of Exam
Multiple Choice

Number of questions
50 questions

Time Limit
1 hour

Passing Grade
60%

Objectives

Upon completion of this program, you will be able to describe:
  • The complexity of biologics vs small molecule drugs
  • Comparisons of biosimilars to innovator biologics
  • Health Canada’s position on and requirements for SEBs, and approval of a biologic for multiple indications
  • Definitions of biosimilarity, bioequivalence, interchangeability, and substitution
  • How “manufacturing drift” can affect biosimilarity
  • The interpretation of biosimilarity data
  • How biosimilars can affect patient safety
  • Global definitions and regulatory environments
  • Implications for public and private coverage
  • Cased-based examples of how small differences between a biosimilar and an innovator biologic may impact efficacy and patient safety
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