How do regulatory approval and evaluation processes for biosimilars differ from those used for small-molecule generic medications?

How do regulatory approval and evaluation processes for biosimilars differ from those used for small-molecule generic medications?

How do regulatory approval and evaluation processes for biosimilars differ from those used for small-molecule generic medications? Can you differentiate based on the specific steps of the approval process, evaluation, clinical trials required, manufacturing process, and regulatory requirements?


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Presenter

Leonard Calabrese, DO

Leonard Calabrese, DO

Professor of Medicine
Cleveland Clinic Lerner College of Medicine of Case Western Reserve University
R.J. Fasenmyer Chair of Clinical Immunology
Vice Chairman Department of Rheumatic and Immunologic Diseases
Orthopaedic and Rheumatologic Institute