Biosimilarity of Follow-On Biologics

Authored by: Shein-Chung Chow , Jen-pei Liu

Encyclopedia of Biopharmaceutical Statistics

Print publication date:  August  2018
Online publication date:  August  2018

Print ISBN: 9781498733953
eBook ISBN: 9781351110273
Adobe ISBN:

10.1201/9781351110273-130001029

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Abstract

This entry will review the issues surrounding biosimilars, including manufacturing, quality control, clinical efficacy, side effects (safety), and immunogenicity. In addition, it will also attempt to address the question regarding how regulatory agencies and industry regulations are evolving to deal with these issues.

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