Development of biosimilars

Seminars in Arthritis and Rheumatism

Volumn 45, Issue 5, 2016, Pages S11-S18

  AL Sabbagh, Ahmad ^a   Olech, Ewa ^b   McClellan, Joseph E ^a   Kirchhoff, Carol F ^a  

^a PFIZER INC   (United States)

^b UNIVERSITY OF NEVADA SCHOOL OF MEDICINE   (United States)

Author keywords

Biologic; Biosimilar; Biosimilarity; Characterization; Chronic inflammatory diseases; Clinical; Comparability; Development; Functional; Immunogenicity; Innovator; Manufacturing; Pharmacodynamics; Pharmacokinetics; Preclinical; Quality; Reference product; Regulatory requirements; Safety; Structural

Indexed keywords

BIOSIMILAR AGENT;

ARTICLE; BIOLOGICAL ACTIVITY; DRUG ACTIVITY; DRUG DEVELOPMENT; DRUG EFFICACY; DRUG MANUFACTURE; DRUG POTENCY; DRUG PURITY; DRUG QUALITY; DRUG SAFETY; DRUG SCREENING; DRUG STRUCTURE; DRUG SURVEILLANCE PROGRAM; IMMUNOGENICITY; INTERNET; LICENSING; PRACTICE GUIDELINE; PRIORITY JOURNAL; DRUG INDUSTRY; FOOD AND DRUG ADMINISTRATION; HUMAN; LEGISLATION AND JURISPRUDENCE; PROCEDURES; UNITED STATES;

BIOSIMILAR PHARMACEUTICALS; DRUG DISCOVERY; DRUG INDUSTRY; HUMANS; UNITED STATES; UNITED STATES FOOD AND DRUG ADMINISTRATION;

EID: 84961179448     PISSN: 00490172     EISSN: 1532866X     Source Type: Journal    
DOI: 10.1016/j.semarthrit.2016.01.002     Document Type: Article

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