Leonard H. 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
Cleveland Clinic Cleveland, OH
Can you discuss and explain the study design, rationale, results, and clinical implications of the most recent clinical evidence — i.e. clinical trials — focused on the safety and efficacy of approved biosimilar therapies, such as INFLIXIMAB-DYYB ...
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, ...
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?
Once robust analytics, pharmacokinetics, pharmacodynamics, and clinical trials confirm the clinical value and safety of the biosimilar, how does this translate into cost savings for patients and healthcare institutions?
Why would specialists want to use biosimilars in their practice? Can you discuss how rheumatologists and pharmacists should make important cost reduction-based clinical decisions when selecting anti-TNF biologics, based on primary differences ...
What clinical scenarios and patient types with RA and related diseases can you imagine where the use of a biosimilar— INFLIXIMAB-DYYB or others—makes good pharmacoeconomic and clinical sense, as opposed to using the reference brand product, ...