An overview of current regulatory requirements for approval of biosimilar insulins

Diabetes Technology and Therapeutics

Volumn 17, Issue 7, 2015, Pages 510-526

  Heinemann, Lutz ^a   Khatami, Hootan ^b   McKinnon, Ross ^c   Home, Philip ^d  

^a Management   (Germany)

^b SANOFI   (France)

^c FLINDERS UNIVERSITY   (Australia)

^d NEWCASTLE UNIVERSITY   (United Kingdom)

Author keywords

[No Author keywords available]

Indexed keywords

BIOSIMILAR AGENT; INSULIN DERIVATIVE;

BIOASSAY; CLINICAL STUDY; DRUG APPROVAL; DRUG EFFICACY; DRUG SAFETY; DRUG SURVEILLANCE PROGRAM; DRUG TOLERABILITY; FOOD AND DRUG ADMINISTRATION; HUMAN; IMMUNOGENICITY; IN VITRO STUDY; NONHUMAN; PHARMACODYNAMICS; PHYSICAL CHEMISTRY; PRACTICE GUIDELINE; PRIORITY JOURNAL; REVIEW; RISK MANAGEMENT; UNITED STATES; EUROPE; LEGISLATION AND JURISPRUDENCE; MEXICO; PROCEDURES; STANDARDS;

BIOSIMILAR PHARMACEUTICALS; DRUG APPROVAL; EUROPE; HUMANS; INSULINS; MEXICO; UNITED STATES; UNITED STATES FOOD AND DRUG ADMINISTRATION;

EID: 84942300689     PISSN: 15209156     EISSN: 15578593     Source Type: Journal    
DOI: 10.1089/dia.2014.0362     Document Type: Review

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