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

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

Reviews withdrawn draft guidance on analytical similarity assessment. Evaluates various methods for analytical similarity evaluation based on FDA’s current gu

As many biological products face losing their patents in the next decade, the pharmaceutical industry needs an abbreviated regulatory pathway for approval of bi

Mass spectrometry is fast becoming an indispensable field for medical professionals. The mass spectrometric analysis of metabolites and proteins promises to rev