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 818-823 (April 2019) DOI: 10.1016/j.cgh.2018.08.064 Copyright © 2019 AGA Institute Terms and Conditions

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 2019 17, 818-823DOI: (10.1016/j.cgh.2018.08.064) Copyright © 2019 AGA Institute Terms and Conditions

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 2019 17, 818-823DOI: (10.1016/j.cgh.2018.08.064) Copyright © 2019 AGA Institute Terms and Conditions