Biosimilars Primer explains the science, manufacturing technology, and regulatory requirements for receiving approval to market biosimilar products. Beginning with an overview of protein structure, function, and production, this class hones in on different types of biologics and how each fights disease. This class highlights how production conditions can alter a biosimilar, causing it to function differently than its reference product. The course ends with a Safety and Regulation section that examines immunogenicity and approaches to demonstrating biosimilar safety and efficacy that have been acceptable to the FDA and EMA. Four real-world case studies illustrate the complexity and versatility of biosimilars in treating various medical conditions. Enroll today!
Understand how biosimilars are designed and what is meant by “The product is the process.”
Learn how biosimilars may differ from their reference product due to the manufacturing process.
Learn the FDA and EMA requirements for biosimilar approval and the underlying regulatory principles involved.
Review four real-world case studies to better understand the challenges and rewards of producing biosimilars.
- Discuss how post-translational modifications can change biosimilars’ intended function.
- Conclude how biosimilars may differ from their reference product due to the biomanufacturing process.
- Justify the EMA’s and FDA’s Totality-of-the-Evidence requirements for biosimilar approval and the underlying scientific, quality, and regulatory principles involved.
- Emphasize the rigorous safety standards required in clinical trials due to the potential of biosimilars triggering immunogenicity.
- Analyze real-world case studies to understand the complexity and versatility of biosimilars in treating different medical conditions.
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