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Biosimilar Drug Product Development - Endrenyi, Laszlo (Editor), and Chow, Shein-Chung (Editor), and Declerck, . Paul (Editor)
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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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Biosimilar Drug Product Development 2020, CRC Press, London

ISBN-13: 9780367552497

Paperback

Biosimilar Drug Product Development 2017, CRC Press Inc, Bosa Roca

ISBN-13: 9781498718790

Hardcover