Jonathan Kay, MD
Director of Clinical Research
Rheumatology Division
Professor of Medicine
University of Massachusetts Medical School
Worcester, MA
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 for RA; with ...
What do we know about the comparative immunogenicity profiles of originator anti-TNF vs biosimilars for infliximab? Do we have sufficient evidence confirming the safety of biosimilars for patients with RA?
What is the important, clinical and regulatory distinction between bioequivalency and interchangeability as it relates to biosimilar drugs and their reference product? What is the current guidance on studies for validating interchangeability?
From a practical perspective, what do the clinician and pharmacist need to know as it relates to what drug will actually be dispensed to the patient when a prescription is issued for the biosimilar or reference drug?
Can you discuss the clinical and pharmacologic implications of each phase — manufacturing, efficacy and safety testing, PK/PD evaluation, clinical outcomes evaluation — in the stepwise approach to regulatory approval of biosimilar therapies, ...
What are the implications of using anti-TNF biosimilars for clinical practice in RA? For cost savings? What have we learned from the studies about biosimilars for infliximab in the setting of RA?
Even though biopharmaceuticals and biosimilars are made in different manufacturing contexts—as opposed to small compound generic drugs—do we have enough data to confirm that such differences are clinically insignificant in the case of, ...
What are the analytical steps in the development process of an anti-TNF biosimilar such as infliximab that will ensure the likelihood that the reference product and biosimilar produce similar clinical effects in patients?
Since the clinical efficacy of biosimilars is typically studied for a single indication, why then are approvals of such biosimilars as INFLIXIMAB-DYYB, for example, extended to other disease states in which the biosimilar was not tested ...
Can you discuss and explain the study design, rationale, results, and clinical implications of the most recent clinical evidence—i.e. clinical trial—focused on the safety, immunogenicity, and efficacy of approved biosimilar therapies for ...
What have we learned about the equivalency and outcome-based efficacy of biosimilars within the context of a “single switch” between the originator and biosimilar, including the NOR- SWITCH study; and what are the implications for clinical practice?
What are the current price differences between the originator product such as brand/originator versions for infliximab versus the biosimilar? Does it vary from country to country? From Europe to the U.S.?
How do biosimilars differ from biomimics?