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Hot Topics in Primary Care: Demystifying the Differences: Follow-on Biologics, Biosimilars, and Generics
Eugene E Wright1, Thomas C Blevins2, Beverly Reed3
1Consulting Associate, Department of Medicine and Department of Community and Family Medicine, Southern Regional Area Health Education Center, Duke University School of Medicine, Durham, NC, USA.
The Journal of Family Practice
|April 5, 2017
Abstract:
Sponsors of follow-on biologics can submit their applications for approval by the US Food and Drug Administration (FDA) under 2 distinct pathways. The submission pathway is determined by the pathway previously used by the reference biologic product, which is the biologic product upon which the follow-on product relies for evidence of safety and efficacy.