The Food and Drug Administration published a biosimilars approval pathway in 2015 that recommends comparative studies demonstrating similar patient responses between proposed biosimilars and reference biologic drugs.
January 01, 2015
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regulatory
Core element of the FDA's regulatory approach to approving biosimilar products.
Biosimilar competition can lead to lower prices for biologic medicines and can prompt originator manufacturers to reduce list prices or offer larger rebates, while the magnitude of patient savings depends on insurance coverage decisions and whether a biosimilar is placed on a pharmacy benefit manager's formulary.
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economic
Typical market and insurance mechanisms affecting patient-level savings from biosimilars.
Biosimilars are follow-on versions of biologic drugs, and biologics are therapeutic products made from living organisms.
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definition
Terminology clarifying what biosimilars and biologics are.
Biosimilars can cost up to 90% less than the brand-name biologic drugs they replicate.
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statistical
Relative pricing difference between biosimilars and originator biologics.
Because biologic drugs are large molecules produced from live cells, biosimilar copies cannot be chemically identical; as a result, regulators historically required clinical studies for biosimilars, and research indicates that advanced analytical techniques can sometimes substitute for large clinical trials to show no clinically meaningful differences.
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scientific
Scientific basis for regulatory approaches to demonstrating biosimilarity.
Expediting approval of generic drugs and biosimilars is a policy approach intended to increase competition in pharmaceuticals and lower prescription drug costs.
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policy
Generalizable policy mechanism to reduce drug prices by increasing availability of lower-cost alternatives.