Biosimilar Drug Product Development

Biosimilar Drug Product Development

Title: Biosimilar Drug Product Development
Author: Laszlo Endrenyi, Dr. Paul Declerck & Shein-Chung Chow
Release: 2017-02-24
Kind: ebook
Genre: Pharmacology & Toxicology, Books, Professional & Technical, Medical, Science & Nature, Chemistry, Business & Personal Finance, Industries & Professions, Biology
Size: 15590092
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.

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