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The past year has seen a multitude of FDA approvals, ranging from IL-23 and JAK inhibitors to biologics and subcutaneous treatment administrations, that have helped redefine what it means to treat IBD.
Maia Kayal, MD, MS, and Kimberly C. Chen, DO, MSHLM, discuss challenges for biosimilars with interchangeable designation related to automatic substitution in the pharmacy.
Maia Kayal, MD, MS, defines interchangeability and reviews the requirements from the FDA, "switching studies," and meaningful difference verses class effect.