Methodologies for Biosimilar Product Development: A Comprehensive Guide

Authored by Sang Joon Lee, this book delves into the practical and challenging issues that are commonly encountered during the development, review, and approval of a proposed biosimilar product. It covers a wide range of topics including the mix-up use of interval hypotheses testing, risk/benefit assessment for non-inferiority/similarity margin, PK/PD bridging studies with multiple references, and the detection of possible reference product change over time.

Key Features of the Book

• Reviews withdrawn draft guidance on analytical similarity assessment.
• Evaluates various methods for analytical similarity evaluation based on FDA’s current guidelines.
• Provides a general approach for the use of n-of-1 trial design for assessment of interchangeability.
• Discusses the feasibility and validity of the non-medical switch studies.
• Offers innovative thinking for detection of possible reference product change over time.

Why This Book Matters

This book embraces innovative thinking of design and analysis for biosimilar studies, which are required for review and approval of biosimilar regulatory submissions. It is a valuable resource for researchers, scientists, and regulatory professionals working in the field of biosimilars.

Publication Details

Publisher: CRC Press

Publication Date: September 30, 2021

Language: English

ISBN: 978-1032071800

eText ISBN: 9781000451948