Biologics are medicinal products derived from living organisms and include macromolecules such as naturally occurring or biotechnology-derived proteins, as well as somatic cell and gene therapy products. Due to the nature of biologic products and their often-novel characteristics, many are innovative products that require case-by-case assessments and individual development strategies, rather than a standard development approach. This, combined with an increasingly complex global regulatory environment, poses specific challenges for biologics manufacturers.
This course provides a comprehensive overview of the special characteristics of biologic products and the challenges associated with their development. It introduces various aspects specific to their manufacturing, nonclinical and clinical development, and some global regulatory considerations that add further complexity (e.g., e-Submission). Each lesson also includes references to regulatory source documents in the US and EU, as well as to international guidance documents that will provide further knowledge and understanding of biologics projects.
Learning Objectives
Upon completion of this course, participants should be able to:
- Define the characteristics of biologics and biotechnology-derived products
- Outline the regulatory evolution of current biologics regulations
- Explain differences between large- and small-molecule drugs
- Identify the challenges of developing biologics for market
- Discuss the status, difficulties and barriers of follow-on biologics/biosimilars
Target Audience
This course is beneficial for regulatory professionals and those interested in understanding the basics of US and EU biologics regulations.