Interchangeability among reference insulin analogues and their biosimilars: regulatory framework, study design and clinical implications

Diabetes, Obesity and Metabolism

Volumn 18, Issue 8, 2016, Pages 737-746

  Dowlat, H A ^a   Kuhlmann, M K ^b   Khatami, H ^c   Ampudia Blasco, F J ^d  

^a PharmaBio Consulting   (Germany)

^b VIVANTES KLINIKUM IM FRIEDRICHSHAIN   (Germany)

^c Fortress Biotech Inc   (United States)

^d HOSPITAL CLÍNICO UNIVERSITARIO   (Spain)

Author keywords

biosimilar; insulin

Indexed keywords

BIOSIMILAR AGENT; INSULIN DERIVATIVE; ANTIDIABETIC AGENT; GENERIC DRUG; INSULIN;

CLINICAL EFFECTIVENESS; CLINICAL PRACTICE; COMPARATIVE STUDY; CONCEPTUAL FRAMEWORK; DECISION MAKING; DIABETES MELLITUS; DRUG APPROVAL; DRUG EFFICACY; DRUG RESPONSE; DRUG SURVEILLANCE PROGRAM; DRUG USE; HUMAN; MEDICAL SOCIETY; NONHUMAN; REVIEW; ANALOGS AND DERIVATIVES; DRUG CONTROL; DRUG SUBSTITUTION; MEDICINAL CHEMISTRY;

BIOSIMILAR PHARMACEUTICALS; CHEMISTRY, PHARMACEUTICAL; DRUG AND NARCOTIC CONTROL; DRUG SUBSTITUTION; DRUGS, GENERIC; HUMANS; HYPOGLYCEMIC AGENTS; INSULIN;

EID: 84970968764     PISSN: 14628902     EISSN: 14631326     Source Type: Journal    
DOI: 10.1111/dom.12676     Document Type: Review

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