Biologic drugs are medicines produced from living cells rather than by chemical synthesis.
high
definitional
Defines what distinguishes biologic drugs from traditional small-molecule drugs.
In the United States, biologic drugs constitute about 5% of prescriptions but account for more than half of the approximately $600 billion spent annually on medicines.
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statistical
Distribution of prescription volume versus share of total drug spending.
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.