Journal
CLINICAL PHARMACOLOGY & THERAPEUTICS
Volume 84, Issue 5, Pages 633-635Publisher
WILEY
DOI: 10.1038/clpt.2008.159
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As patents for the first generation of biotechnology-derived medicines expire, regulators must develop standards for follow-ons. Requirements for traditional generic drugs will often be insufficient because follow-on biotechnology medicines will not be identical to reference products. Policymakers must also consider what products to include, how to set data requirements, whether to permit interchange of follow-ons and reference products, what postmarket requirements to impose, and how to balance cost savings from follow-ons against incentives for innovation.
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