Erschienen in:
21.10.2019 | Concise Research Report
FDA and EMA Biosimilar Approvals
verfasst von:
Emily H. Jung, A.B., Ameet Sarpatwari, Ph.D. J.D.,, Aaron S. Kesselheim, M.D., J.D., M.P.H., Michael S. Sinha, M.D., J.D., M.P.H.
Erschienen in:
Journal of General Internal Medicine
|
Ausgabe 6/2020
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Excerpt
In 2010, Congress streamlined Food and Drug Administration (FDA) approval of versions of biologic drugs made by other manufacturers (“biosimilars”) after market exclusivity expiration. This pathway, codified in section 351(k) of the Public Health Service Act, was intended to leverage existing knowledge about originator biologics to require fewer trials. By reducing cost of entry, policymakers incentivized competition and lower drug prices. …