How Similar Are Biosimilars? What Do Clinicians Need to Know About Biosimilar and Follow-On Insulins?

Author:

Triplitt Curtis1,Hinnen Debbie2,Valentine Virginia3

Affiliation:

1. Texas Diabetes Institute, University Health System, University of Texas Health Science Center, San Antonio, TX

2. Memorial Hospital Outpatient Diabetes Clinic, University of Colorado Health, Colorado Springs, CO

3. College of Nursing, School of Medicine, and College of Pharmacy, University of New Mexico, Albuquerque, NM

Abstract

IN BRIEF As more patents on biological medicines expire, increased numbers of biologic copies, referred to as “biosimilars,” will likely become available in the United States in the coming years. With greater availability and the drive for health care savings, the use of biosimilars and of “follow-on” biological products is likely to increase in routine clinical practice. Health care practitioners need to be fully aware of these products and accompanying considerations if they are to make informed decisions together with their patients.

Publisher

American Diabetes Association

Subject

Endocrinology, Diabetes and Metabolism,Internal Medicine

Reference38 articles.

1. Biologicals and biosimilars: a review of the science and its implications;Declerck;GaBI J,2012

2. U.S. Food and Drug Administration. Facts about generic drugs [Internet]. Available from http://www.fda.gov/Drugs/ResourcesForYou/Consumers/BuyingUsingMedicineSafely/UnderstandingGenericDrugs/ucm167991.htm. Accessed 25 May 2016

3. Biosimilar insulins: a European perspective;DeVries;Diabetes Obes Metab,2015

4. U.S. Food and Drug Administration. Scientific considerations in demonstrating biosimilarity to a reference product [Internet]. Available from http://www.fda.gov/downloads/DrugsGuidanceComplianceRegulatoryInformation/Guidances/UCM291128.pdf. Accessed 16 May 2016

5. U.S. Food and Drug Administration. Labeling for biosimilar products [Internet]. Available from http://www.fda.gov/downloads/drugs/guidancecomplianceregulatoryinformation/guidances/ucm493439.pdf. Accessed 25 May 2016

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