Biosimilar drug product development / edited by Laszlo Endrenyi, University of Toronto, Canada, Paul Jules Declerck, KU Leuven, Leuven, Belgium, Shein-Chung Chow, Duke University School of Medicine, Durham, USA.

Includes bibliographical references and index.

Introduction : scientific factors in biosimilar drug product development / Laszlo Endrenyi, Paul Declerck, Shein-Chung Chow -- Analytical characterization : structural assessment of biosimilarity / Steven Berkowitz -- Analytical similarity assessment / Shein-Chung Chow, Li Liu -- Characterization of biosimilar biologics : the link between structure and functions / Roy Jefferis -- Manufacturing and process control issues - quality development of biosimilar medicinal products / Alan Fauconnier, Lyudmil Antonov -- Animal studies / Karen de Smet, Leon van Aerts -- The clinical development of biosimilar drugs / Mark McCamish, Gillian R. Woollett, Sigrid Balser -- Statistical methods for biosimilarity / Shein-Chung Chow, Fuyu Song -- Extrapolation of indications / Jian Wang, Wallace Lauzon, Catherine Njue, Agnes V. Klein -- Interchangeability, switchability and substitution of biosimilars / Paul Declerck, Laszlo Endrenyi, Shein-Chung Chow -- Design and analysis of studies for assessing interchangeability / Shein-Chung Chow, Laszlo Endrenyi -- Role of immunogenicity evaluation for biosimilars / Paul Chamberlain -- Pharmacovigilance of biosimilars / Shehla Hashim, Souleh Semalulu, Felix Omara, Duc Vu -- Patent exclusivities affecting biosimilars in the United States, Canada and Europe / Lynn Tyler, Noel Courage -- Biosimilars in the EU : regulatory guidelines / Sol Ruiz -- Biosimilars and biologics : the prospects for competition / Erwin A. Blackstone, Joseph P. Fuhr, Jr. -- Plant-produced biosimilar products / Kenny K. Y. So, Michael R. Marit, J. Christopher Hall, Michael D. McLean.