Hot Topics in Primary Care: Demystifying the Differences: Follow-on Biologics, Biosimilars, and Generics.

Autor:	Wright EE Jr; Consulting 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., Blevins TC; Texas Diabetes and Endocrinology, Austin, TX, USA., Reed B; Eli Lilly and Company, Indianapolis, IN, USA., Pollom RD; Eli Lilly and Company, Indianapolis, IN, USA.
Jazyk:	angličtina
Zdroj:	The Journal of family practice [J Fam Pract] 2017 Apr; Vol. 66 (4 Suppl), pp. S22-S27.
Abstrakt:	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.
Databáze:	MEDLINE
Externí odkaz:	Zobrazit plný text záznamu Plný text ve formátu PDF