After physicochemical criteria are met, what kind of clinical trials, with what end points and safety profiles must be achieved for regulatory agencies to approve biosimilars?

After physicochemical criteria are met, what kind of clinical trials, with what end points and safety profiles must be achieved for regulatory agencies to approve biosimilars?

After physicochemical criteria are met, what kind of clinical trials, with precisely what end points and safety profiles must be achieved for regulatory agencies to approve biosimilars, and for what range of indications can such approvals be made?


Created by

CMEducation Resources IQ&A Interactive Intelligence Zone

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