Biosimilars: Part 1: Proposed regulatory criteria for FDA approval

P and T

Volumn 38, Issue 5, 2013, Pages

  Lee Ventola, C ^a  

^a NONE

Author keywords

[No Author keywords available]

Indexed keywords

ADALIMUMAB; BIOSIMILAR AGENT; IMIGLUCERASE; MONOCLONAL ANTIBODY;

ARTICLE; BIOLOGICAL THERAPY; CROHN DISEASE; DRUG APPROVAL; DRUG BIOAVAILABILITY; DRUG EFFICACY; DRUG SAFETY; ENZYME LINKED IMMUNOSORBENT ASSAY; FOOD AND DRUG ADMINISTRATION; GAUCHER DISEASE; GEL PERMEATION CHROMATOGRAPHY; GLYCOSYLATION; HEALTH CARE; HIGH PERFORMANCE LIQUID CHROMATOGRAPHY; HUMAN; IMMUNE RESPONSE; IMMUNOGENICITY; MASS SPECTROMETRY; NUCLEAR MAGNETIC RESONANCE; PHYSICAL CHEMISTRY; PRACTICE GUIDELINE; RHEUMATOID ARTHRITIS;

EID: 84878080621     PISSN: 10521372     EISSN: None     Source Type: Journal    
DOI: None     Document Type: Article

References (19)

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