Erschienen in:
23.06.2020 | Concise Research Report
Uptake and Usage Patterns of Biosimilar Infliximab in the Medicare Population
verfasst von:
Steven Kozlowski, MD, Natasha Flowers, BA, Noy Birger, MPH, Michael Wernecke, BA, Thomas E. MaCurdy, PhD, Jeffrey A. Kelman, MD, MMSc, David J. Graham, MD, MPH
Erschienen in:
Journal of General Internal Medicine
|
Ausgabe 7/2021
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Excerpt
Biological products are high-cost, complex therapeutics used to treat severe and chronic conditions. The Biologics Price Competition and Innovation Act created an abbreviated approval pathway for US biosimilar and interchangeable biological products in 2010. This abbreviated approval pathway allows for extrapolation of the conclusion of biosimilarity across clinical indications based on the totality of evidence from a data package that may include data for only one clinical indication, with sufficient scientific justification. As of December 9, 2019, twenty-six biosimilars were approved by the US Food and Drug Administration (FDA), including four biosimilars for infliximab. …