Course Videos
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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?
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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?
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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?
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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 ...
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Based on your current assessment of anti-TNF biosimilars, what is the optimal trajectory of these agents in the setting of RA and related immune-related conditions?
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Based on the available data for clinical equivalency and switching, can you discuss how rheumatologists and pharmacists should make clinical decisions when choosing between biosimilars and their reference biologic agents in the setting ...
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Can you explain current policy guidance as it relates to biosimilars, including considerations that do or do not apply to interchangeability for anti-TNF biosimilars and product naming guidelines? What is the threshold for interchangeability?
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When trying to assess the data and clinical rationale for switching from an originator anti-TNF to a biosimilar, it appears that the single switch data is convincing in supporting the efficacy, safety, and comparable immunogenicity of ...
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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?
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Can you compare, based on published RA trials, both the clinical efficacy/equivalency and adverse side effects that have been reported with administration of the anti-TNF biosimilar versus the originator product, infliximab? And how do ...
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Can you discuss and explain the study design, rationale, results, and practical clinical implications of the most recent clinical evidence focused on anti-TNF inhibitor biosimilars for infliximab in the setting of RA; and by extrapolation, ...
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How do regulatory approval and evaluation processes for biosimilars differ from those used for small-molecule generic medications? Can you differentiate these processes based on the specific steps of the approval process; including structural ...