Biosimilars: Regulatory, Clinical, and Biopharmaceutical Development (AAPS Advances in the Pharmaceutical Sciences Series, Book 34) by Hiten J. Gutka and Harry Yang
English | 2018 | ISBN: 3319996797 | 709 pages | PDF | 11,7 MB
This book provides a comprehensive overview of the biosimilar regulatory framework, the development process and clinical aspects for development of biosimilars. The development path of a biosimilar is just as unique as a development path of a new drug, tailored by the mechanism of action, the quality of the molecule, published information on the reference product, the current competitive environment, the target market and regulatory guidance, and most importantly, the emerging totality of evidence for the proposed biosimilar during development.
For the ease of readers, the book comprises of six sections as follows:
Section I: Business, Health Economics and Intellectual Property Landscape for Biosimilars
Section II: Regulatory Aspects of Development and Approval for Biosimilars
Section III: Biopharmaceutical Development and Manufacturing of Biosimilars
Section IV: Analytical Similarity Considerations for Biosimilars
Section V: Clinical aspects of Biosimilar Development
Section VI: Biosimilars- Global Development and Clinical Experience
Chapters have been written by one or more experts from academia, industry or regulatory agencies who have been involved with one or more aspects of biosimilar product development. The authors and editors have an expertise in commercialization and pricing of biosimilars, intellectual property considerations for biosimilars, chemistry manufacturing controls (CMC) and analytical development for biosimilars, regulatory and clinical aspects of biosimilar development. Besides the industry practitioners, the book includes several contributions from regulators across the globe.
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