Course Videos
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Where does the evidentiary grounding come from to achieve FDA approval for a biosimilar? How many clinical trials are required to support the analytics? What end points are evaluated? Molecularly speaking, how close is the end result likely ...
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What can we expect in terms of price reductions for biosimilar vs. the reference product? What factors determine these pricing patterns for biosimilars?
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In general, what kinds of comparable outcomes and end points are investigators documenting for when comparing the reference molecule to a biosimilar agent that is being evaluated for similar disease states?
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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.?
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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 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 ...
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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 ...
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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?
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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, ...
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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?
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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, ...
