Methodologies for Biosimilar Product Development covers the practical and challenging issues that are commonly encountered during the development, review, and a

When a biological drug patent expires, alternative biosimilar products are developed. The development of biosimilar products is complicated and involves numerou

Biosimilars have the potential to change the way we think about, identify, and manage health problems. They are already impacting both clinical research and pat

This book focuses on analytical similarity assessment in biosimilar product development following the FDA’s recommended stepwise approach for obtaining totali

This book provides a comprehensive overview of the biosimilar regulatory framework, the development process and clinical aspects for development of biosimilars.