Regulation of Biosimilars
Biological products are proteins that are derived from cells or tissues. Biosimilars are biological products that have been demonstrated to have sufficient similarities to a previously approved biological drug, and therefore can gain approval with a reduced clinical and nonclinical data package. Unlike small molecule generics, the complexity of a biologic does not permit the production of an exact copy of the approved product. Not surprisingly then, the biosimilar approval process is more complex and is still evolving, as regulatory agencies and manufacturers work to collaboratively understand the issues arising from biologic products that are similar but not identical.
This first part of the course will examine the sources of complexity in biologics and their production processes. The remainder of the course will provide an overview of the current guidance documents available to address the regulatory approval pathways for biosimilars, and compare the quality, nonclinical and clinical aspects of biosimilar development in three major regulatory jurisdictions, namely the EU, US and Canada.
At a Glance
- Target Audience: This course is for regulatory professionals interested in biosimilar development and regulatory approval strategies.
- Learning Level: Basic
- Total Length of Course: 2 Hours
- RAC Points: 2
- Pharmaceutical Certificate Elective
- Enrollment Period: 12 months
Learning Objectives
Upon completion of this course, participants should 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
This course is also included in:
