Biosimilars: The US Regulatory Framework∗

Annual Review of Medicine

Volumn 68, Issue , 2017, Pages 243-254

  Christl, Leah A ^a   Woodcock, Janet ^a   Kozlowski, Steven ^a  

^a CENTER FOR DRUG EVALUATION AND RESEARCH   (United States)

Author keywords

Biologic; Biosimilar; Interchangeable

Indexed keywords

BIOSIMILAR AGENT; MONOCLONAL ANTIBODY;

ARTICLE; BIOTECHNOLOGY; COEVOLUTION; DRUG MARKETING; FOOD AND DRUG ADMINISTRATION; HUMAN; PRIORITY JOURNAL; QUALITY CONTROL; UNITED STATES; DRUG APPROVAL; DRUG LABELING; DRUG SUBSTITUTION; LEGISLATION AND JURISPRUDENCE; STANDARDS;

ANTIBODIES, MONOCLONAL; BIOSIMILAR PHARMACEUTICALS; DRUG APPROVAL; DRUG LABELING; DRUG SUBSTITUTION; HUMANS; QUALITY CONTROL; UNITED STATES; UNITED STATES FOOD AND DRUG ADMINISTRATION;

EID: 85010016463     PISSN: 00664219     EISSN: 1545326X     Source Type: Book Series    
DOI: 10.1146/annurev-med-051215-031022     Document Type: Article

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