© 2018


Regulatory, Clinical, and Biopharmaceutical Development

  • Hiten J. Gutka
  • Harry Yang
  • Shefali Kakar

Part of the AAPS Advances in the Pharmaceutical Sciences Series book series (AAPS, volume 34)

Table of contents

  1. Front Matter
    Pages i-xxiii
  2. Business, Health Economics and Intellectual Property Landscape for Biosimilars

  3. Regulatory Aspects of Development and Approval for Biosimilars

    1. Front Matter
      Pages 105-105
    2. Pekka Kurki, Niklas Ekman
      Pages 145-169
  4. Biopharmaceutical Development and Manufacturing of Biosimilars (Chemistry and Manufacturing Controls (CMC), Quality by Design (QbD), Quality Target Product Profile (QTPP))

    1. Front Matter
      Pages 171-171
    2. Christina Vessely, Christopher Bussineau
      Pages 187-219
    3. Satish K. Singh, Susanne Jörg, Hanns-Christian Mahler
      Pages 221-258
  5. Analytical Similarity Considerations for Biosimilars (Protein characterization, Biophysical Tools, Biological Assays, Statistical Methods)

    1. Front Matter
      Pages 259-259
    2. Kristof Vandekerckhove, Russell Reeve
      Pages 261-303
    3. Jared A. Young, John P. Gabrielson
      Pages 321-337

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.


therapeutics quality by design biologics preclinical safety chemistry and manufacturing controls (CMC)

Editors and affiliations

  • Hiten J. Gutka
    • 1
  • Harry Yang
    • 2
  • Shefali Kakar
    • 3
  1. 1.Oncobiologics Inc.CranburyUSA
  2. 2.Statistical Sciences, MedImmune LLCGaithersburgUSA
  3. 3.Novartis (United States)East HanoverUSA

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
  • Series Abbreviated Title AAPS Adv. Pharmaceutical Sciences
  • DOI
  • Copyright Information American Association of Pharmaceutical Scientists 2018
  • Publisher Name Springer, Cham
  • eBook Packages Biomedical and Life Sciences Biomedical and Life Sciences (R0)
  • Hardcover ISBN 978-3-319-99679-0
  • eBook ISBN 978-3-319-99680-6
  • 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
  • Topics Pharmaceutical Sciences/Technology
  • Buy this book on publisher's site
Industry Sectors
Health & Hospitals
Consumer Packaged Goods