Regulation of Biosimilars

The biosimilar approval process is complex and evolving. As a result, regulatory agencies and manufacturers have to collaboratively understand the issues arising from biologic products that are similar but not identical, that will insure their safety and efficacy.

This first part of the course will examine the structural complexity of biologics and the challenges associated with their production processes. The remainder of the course will review current guidance and discuss the quality, nonclinical and clinical aspects of biosimilar development in three major regulatory jurisdictions, namely the EU, US and Canada.




  • At A Glance
  • Learning Objectives
  • Lesson Titles
  • Registration Options

At A Glance

  • Target Audience: This course is for regulatory professionals interested in biosimilar development and regulatory approval strategies.
  • Learning LevelBasic
  • Total Length of Course: 2–4 Hours
  • RAC Credits: 2
  • Cost: Member $250; Nonmember $345
  • Format: PC and Tablet (iPad and Android)
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Learning Objectives

Upon completion of this course, participants will be able to:

  • Appreciate the complexities inherent in biological drug products and their production processes which contribute to the technical challenges associated with the development of a biosimilar
  • Outline the regulatory approval pathways for biosimilars in the EU, US and Canada
  • Describe the requirements for analytical comparability testing and elements in the quality section of the biosimilar regulatory approval applications
  • Discuss the considerations for design of a successful nonclinical testing program for biosimilars
  • Highlight key factors in designing a global biosimilar clinical development program, identifying the common requirements for the EU, US and Canada

Lesson Titles

  • Lesson 1: Development History and Complexities of the Production Process of Biological Drugs
  • Lesson 2: History and Legal Aspects of Biosimilars
  • Lesson 3: Quality Considerations
  • Lesson 4: Nonclinical and Clinical Requirements for Biosimilars

Registration Options

This course is available for purchase as follows: