Biosimilar Drug Product Development

When a biological drug patent expires, alternative biosimilar products are developed. The development of biosimilar products is complicated and involves numerous considerations and steps. The assessment of biosimilarity and interchangeability is also complicated and difficult. Biosimilar Drug Product Development presents current issues for the development of biosimilars and gives detailed reviews of its various stages and contributing factors as well as relevant regulatory pathways and pre- and post-approval issues.

About the author

Laszlo Endrenyi, Professor Emeritus, University of Toronto

Product details

• Authors: Laszlo (University of Toronto Endrenyi
• Assisted by: Shein-Chung Chow (Editor), . Paul Declerck (Editor), Dr. Paul Declerck (Editor), Laszlo Endrenyi (Editor), Endrenyi Laszlo (Editor)
• Publisher: Taylor & Francis Ltd.
• Languages: English
• Product format: Hardback
• Released: 07.03.2017
• EAN: 9781498718790
• ISBN: 978-1-4987-1879-0
• No. of pages: 496
• Series: Drugs and the Pharmaceutical Sciences
• Subjects: Natural sciences, medicine, IT, technology > Medicine > Non-clinical medicine; Social sciences, law, business > Business > Individual industrial sectors, branches; MEDICAL / Pharmacy, SCIENCE / Chemistry / General, MEDICAL / Pharmacology, environmental science, engineering & technology, Biology, life sciences, Engineering: general, Pharmaceutical technology, Manufacturing industries, Environmental science, engineering and technology, Pharmaceutical industries, Pharmaceutical chemistry and technology