1. Switching Between Biologics and Biosimilars in Inflammatory Bowel Disease 
Laura E. Raffals, Geoffrey C. Nguyen, David T. Rubin 
Clinical Gastroenterology and Hepatology 
Volume 17, Issue 5, Pages (April 2019)
DOI: /j.cgh
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2. Figure 1
Manufacturing of biologic products is complex involving multiple steps that may vary between manufacturers, which may lead to differences between a biosimilar and reference product that cannot be fully characterized using available analytical techniques.
Clinical Gastroenterology and Hepatology  , DOI: ( /j.cgh )
Copyright © 2019 AGA Institute Terms and Conditions

3. Figure 2
The Food and Drug Administration suggests a stepwise approach to demonstrate biosimilarity of a proposed biosimilar to an originator biologic. This process includes studies demonstrating similarity in structure and function, animal toxicity, human pharmacokinetics (PK) and pharmacodynamics (PD), and immunogenicity, as well as clinical safety and efficacy. The Food and Drug Administration considers the totality of evidence to determine biosimilarity.
Clinical Gastroenterology and Hepatology  , DOI: ( /j.cgh )
Copyright © 2019 AGA Institute Terms and Conditions