Biosimilars: A consideration of the regulations in the United States and European union

Regulatory Toxicology and Pharmacology

Volumn 76, Issue , 2016, Pages 199-208

  Daller, Justin ^a  

^a BAXTER HEALTHCARE CORPORATION   (United States)

Author keywords

Biosimilar; Extrapolation; Interchangeability; Pharmacovigilance; Regulation

Indexed keywords

BIOSIMILAR AGENT; FILGRASTIM; INFLIXIMAB;

BIOLOGICAL ACTIVITY; DRUG APPROVAL; DRUG CONTROL; DRUG EFFICACY; DRUG MANUFACTURE; DRUG MARKETING; DRUG SAFETY; DRUG SURVEILLANCE PROGRAM; EUROPEAN UNION; GOVERNMENT REGULATION; HUMAN; NOTE; PHARMACODYNAMICS; PHYSICAL CHEMISTRY; PRIORITY JOURNAL; UNITED STATES; EUROPE; FOOD AND DRUG ADMINISTRATION; LEGISLATION AND JURISPRUDENCE; MANAGEMENT; PATIENT SAFETY; PRACTICE GUIDELINE; RISK ASSESSMENT;

BIOSIMILAR PHARMACEUTICALS; DRUG AND NARCOTIC CONTROL; DRUG APPROVAL; EUROPE; GOVERNMENT REGULATION; GUIDELINES AS TOPIC; HUMANS; PATIENT SAFETY; PHARMACOVIGILANCE; POLICY MAKING; RISK ASSESSMENT; UNITED STATES; UNITED STATES FOOD AND DRUG ADMINISTRATION;

EID: 84953318052     PISSN: 02732300     EISSN: 10960295     Source Type: Journal    
DOI: 10.1016/j.yrtph.2015.12.013     Document Type: Note

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