When a biological drug patent expires, alternative biosimilar products are developed. The development of biosimilar products is complicated and involves numerous considerations and steps. The assessment of biosimilarity and interchangeability is also complicated and difficult. Biosimilar Drug Product Development presents current issues for the development of biosimilars and gives detailed reviews of its various stages and contributing factors as well as relevant regulatory pathways and pre- and post-approval issues.

chapter 1|14 pages


Scientific Factors in Biosimilar Product Development
ByLaszlo Endrenyi, Paul Declerck, Shein-Chung Chow

chapter 2|68 pages

Analytical Characterization

Structural Assessment of Biosimilarity
BySteven A. Berkowitz

chapter 3|26 pages

Analytical Similarity Assessment

ByShein-Chung Chow, Li Liu

chapter 4|41 pages

Characterization of Biosimilar Biologics

The Link between Structure and Functions
ByRoy Jefferis

chapter 5|23 pages

Manufacturing and Process Control Issues

Quality Development of Biosimilar Medicinal Products
ByAlan Fauconnier, Lyudmil Antonov

chapter 6|22 pages

Nonclinical Studies for Biosimilars

ByKaren De Smet, Leon AGJM van Aerts

chapter 7|21 pages

The Clinical Development of Biosimilar Drugs

ByMark McCamish, Gillian Woollett, Sigrid Balser

chapter 8|43 pages

Statistical Methods for Assessing Biosimilarity

ByShein-Chung Chow, Fuyu Song

chapter 9|19 pages

Extrapolation of Indications for Biosimilars

Opportunity for Developers and Challenges for Regulators
ByJian Wang, Wallace Lauzon, Catherine Njue, Agnes V. Klein

chapter 10|14 pages

Interchangeability, Switchability, and Substitution of Biosimilar Products

ByPaul Declerck, Laszlo Endrenyi, Shein-Chung Chow

chapter 11|25 pages

Design and Analysis of Studies for Assessing Interchangeability

ByShein-Chung Chow, Laszlo Endrenyi

chapter 12|37 pages

The Role of the Immunogenicity Evaluation for Biosimilars

ByPaul Chamberlain

chapter 13|13 pages

Pharmacovigilance of Biosimilars

ByShehla Hashim, Souleh Semalulu, Felix Omara, Duc Vu

chapter 14|19 pages

Patent Exclusivities Affecting Biosimilars in the United States, Canada, and Europe

ByNoel Courage, Lynn C. Tyler

chapter 15|17 pages

Biosimilars in the EU

Regulatory Guidelines
BySol Ruiz

chapter 16|26 pages

Biosimilars and Biologics

The Prospects for Competition
ByErwin A. Blackstone, Joseph P. Fuhr

chapter 17|19 pages

Plant-Based Production of Biosimilar Drug Products

ByKenny K. Y. So, Michael R. Marit, Michael D. McLean, J. Christopher Hall