Editors:
- Discusses the regulatory landscape and policies that define and govern the approval of biosimilar therapeutics in different geographies
- Focus on QbD and analytical similarity for biosimilar development
- Increase reader’s understanding of how CMC and clinical areas play a key role in biosimilar designation and approval
Part of the book series: AAPS Advances in the Pharmaceutical Sciences Series (AAPS, volume 34)
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Table of contents (25 chapters)
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Front Matter
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Business, Health Economics and Intellectual Property Landscape for Biosimilars
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Front Matter
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Regulatory Aspects of Development and Approval for Biosimilars
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Front Matter
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Biopharmaceutical Development and Manufacturing of Biosimilars (Chemistry and Manufacturing Controls (CMC), Quality by Design (QbD), Quality Target Product Profile (QTPP))
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Front Matter
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Analytical Similarity Considerations for Biosimilars (Protein characterization, Biophysical Tools, Biological Assays, Statistical Methods)
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Front Matter
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About this book
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.
Editors and Affiliations
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Oncobiologics Inc., Cranbury, USA
Hiten J. Gutka
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Statistical Sciences, MedImmune LLC, Gaithersburg, USA
Harry Yang
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Novartis (United States), East Hanover, USA
Shefali Kakar
About the editors
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 got his PhD in Pharmacognosy (Pharmaceutical Biotechnology track) from University of Illinois at Chicago (UIC), College of Pharmacy. Dr. Gutka worked at Biocon, USV and Reliance Biopharmaceuticals in India, on analytical and pharmaceutical development of biosimilar Insulins and other biosimilars including cytokines and hormones. He got his Bachelors in Pharmaceutical Sciences from University of Mumbai, India and Masters in Pharmaceutical Sciences from University Institute of Chemical Technology, Mumbai, India. Hiten is a member of the American Association of Pharmaceutical Sciences (AAPS). He serves on the editorial board of the journal mAbs.
Harry Yang, Ph.D., is Senior Director and Head of Statistical Sciences at MedImmune. He has participated in industry initiatives related to Quality by Design, analytical method development and validation, and sterile drug product bioburden testing. He has 23 years of experience in drug discovery, pre-clinical and clinical study design and analysis, translational sciences, biopharmaceutical development, manufacturing, and regulatory submissions. He has authored 5 statistical books and published 14 book chapters and more than 90 papers. He received his Bachelor’s and Master’s degrees in Applied Mathematics from Peking University, and Ph.D. in Statistics from the University of Pittsburgh.
Shefali Kakar PhD., is an Executive Director, Global Head Respiratory, in the Novartis Pharmacokinetic Sciences group. She is responsible for overseeing all aspects of pharmacokinetics sciences (ADME, PK/PD, and clinical pharmacology) for the respiratory portfolio ranging from early discovery to full development. Dr. Kakar has over 15 years of industrial experience and has been involved in discovery and development of over 40 small molecules and protein therapeutics, including biosimilars. Prior to joining Novartis, Dr. Kakar worked at Pfizer and also served as an Adjunct faculty at the Brown University. She received her PhD in Pharmacology from University of Michigan.Bibliographic Information
Book Title: Biosimilars
Book Subtitle: Regulatory, Clinical, and Biopharmaceutical Development
Editors: Hiten J. Gutka, Harry Yang, Shefali Kakar
Series Title: AAPS Advances in the Pharmaceutical Sciences Series
DOI: https://doi.org/10.1007/978-3-319-99680-6
Publisher: Springer Cham
eBook Packages: Biomedical and Life Sciences, Biomedical and Life Sciences (R0)
Copyright Information: American Association of Pharmaceutical Scientists 2018
Hardcover ISBN: 978-3-319-99679-0Published: 29 December 2018
eBook ISBN: 978-3-319-99680-6Published: 13 December 2018
Series ISSN: 2210-7371
Series E-ISSN: 2210-738X
Edition Number: 1
Number of Pages: XXIII, 709
Number of Illustrations: 25 b/w illustrations, 93 illustrations in colour