Biosimilars

Biosimilars explain the science, manufacturing technology, and regulatory requirements for receiving approval to market biosimilar products. Beginning with an overview of protein structure, function, and production, the class hones in on different types of biologics and how each mitigates disease. The Manufacturing section highlights how conditions can alter a biosimilar, causing it to function differently than its reference product. The Safety and Regulation section examines immunogenicity and approaches to demonstrating biosimilar safety and efficacy that have been acceptable to the FDA and EMA. The class ends with four case studies demonstrating the real-world complexity of biosimilar science, manufacturing, and regulatory challenges.