Biosimilars
Subtitle: design and analysis of follow-on biologics
By: Shein-Chung Chow
Series: Chapman & Hall/CRC biostatistics series -- 60
Publisher: Taylor & Francis; Routledge; Chapman and Hall/CRC
Published: 2014
Place of publication: Boca Raton
Language: eng
Number of pages: 424
ISBN-13: 9781466579699; 9781466579705
Subjects: Pharmaceutical biotechnology; Pharmaceutical biotechnology industry; Drugs; Generic substitution; Pharmaceutical policy; Biological products; MATHEMATICS / Probability & Statistics / General; MEDICAL / Pharmacology
Description: "This is the first book entirely devoted to the design and analysis for assessment of biosimilarity and drug interchangeability of biosimilars, and test for comparability in manufacturing processes of biologic products. It covers all of the statistical issues that may occur in biosimilar studies under various study designs at various stages of research and development of biologic products"--

"Biologic drug products are therapeutic moieties that are manufactured using a living system or organism. These are important life-saving drug products for patients with unmet medical needs. They also comprise a growing segment in the pharmaceutical industry. In 2007, for instance, worldwide sales of biological products reached $94 billion US dollars, accounting for about 15% of the pharmaceutical industry's gross revenue. Meanwhile, many biological products face losing their patents in the next decade"--
Notes: Includes bibliographical references (pages 397-410) and index.