Biosimilars: Regulatory, Clinical, And Biopharmaceutical Development

December 29, 2018|
Biosimilars: Regulatory, Clinical, And Biopharmaceutical Development by Hiten J. Gutka
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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.

Hiten Gutka PhD., is an Associate Director Formulation Development at Oncobiologics Inc. where he works on biosimilar drug product development. He worked on formulation and stabilization of novel insulin analogues at Thermalin Diabetes LLC. He did a co-op at Medimmune LLC, in the Formulation and Drug Product Development group. Hiten go...
Title:Biosimilars: Regulatory, Clinical, And Biopharmaceutical DevelopmentFormat:HardcoverProduct dimensions:709 pages, 9.25 X 6.1 X 0 inShipping dimensions:709 pages, 9.25 X 6.1 X 0 inPublished:December 29, 2018Publisher:Springer NatureLanguage:English

The following ISBNs are associated with this title:

ISBN - 10:3319996797

ISBN - 13:9783319996790

Appropriate for ages: All ages

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