title: FDA-approved biosimilar insulin: good enough for critical care, adulterated, or counterfeit? How can we tell?
abstract: If a biosimilar insulin is discovered postmarketing to be subpotent, superpotent, or contaminated or the contents mislabeled, it is an adulterated product and must be quarantined for removal including from a patient's home. Adulterated products could be considered "counterfeit" since they do not meet the original standards established by the FDA. The FDA must establish a method of regularly assaying samples of biosimilar insulin drawn directly from the supply pipeline to help ensure patient safety and evaluate clinical performance. Independent groups without conflict of interest would perform confidential comparison assay. For less than 5 cents per vial/pen, manufacturers could easily support an independent, FDA-recognized, random sample program and create a functional postmarket surveillance system that better protects the public and the manufacturer from undesired outcomes.
authors.affiliation: MRIGlobal, Inc, University of Missouri-Kansas City School of Pharmacy, Kansas City, MO, USA acarter@mriglobal.org.
authors.forename: Alan W
authors.initials: AW
authors.lastname: Carter
mesh_terms: D059451:Biosimilar Pharmaceuticals / Q000627:therapeutic use*; D004340:Drug Contamination / Q000331:legislation & jurisprudence / Q000517:prevention & control; D006801:Humans; D007328:Insulin / Q000627:therapeutic use*; D011358:Product Surveillance, Postmarketing; D011785:Quality Assurance, Health Care / Q000331:legislation & jurisprudence; D014481:United States; D014486:United States Food and Drug Administration
chemical_list: D059451:Biosimilar Pharmaceuticals; D007328:Insulin
keywords: adulterated; assay; biosimilar insulin; cost; counterfeit; postmarket; program; public; safety; standards; surveillance