Understanding utilization patterns of biologics and biosimilars in the United States to support postmarketing studies of safety and effectiveness-Reference-Cited by-同舟云学术

Understanding utilization patterns of biologics and biosimilars in the United States to support postmarketing studies of safety and effectiveness

Published:2019-12-11 Issue:7 Volume:29 Page:786-795
ISSN:1053-8569
Container-title:Pharmacoepidemiology and Drug Safety
language:en
Short-container-title:Pharmacoepidemiol Drug Saf

Author:

Dutcher Sarah K.¹^ORCID,Fazio‐Eynullayeva Elnara²^ORCID,Eworuke Efe¹^ORCID,Carruth Amanda²,Dee Elizabeth C.²,Blum Michael D.¹,Nguyen Michael D.¹^ORCID,Toh Sengwee²^ORCID,Panozzo Catherine A.²^ORCID,Lyons Jennifer G.²^ORCID

Affiliation:

1. Office of Surveillance and Epidemiology, Center for Drug Evaluation and Research Food and Drug Administration Silver Spring MD USA

2. Department of Population Medicine Harvard Medical School and Harvard Pilgrim Health Care Institute Boston MA USA

Funder

U.S. Food and Drug Administration

Publisher

Wiley

Subject

Pharmacology (medical),Epidemiology

Link

https://onlinelibrary.wiley.com/doi/pdf/10.1002/pds.4908

Reference30 articles.

2. Food and Drug Administration.Purple book: lists of licensed biological products with reference product exclusivity and biosimilarity or interchangeability evaluations. Available at:https://www.fda.gov/drugs/developmentapprovalprocess/howdrugsaredevelopedandapproved/approvalapplications/therapeuticbiologicapplications/biosimilars/ucm411418.htm.

3. Food and Drug Administration.Considerations in demonstrating interchangeability with a reference product: guidance for industry. May2019.

4. Food and Drug Administration.Nonproprietary naming of biological products: guidance for industry. January2017.

5. Uptake of the Biologic Filgrastim and Its Biosimilar Product Among the Medicare Population

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