Biosimilars: Rationale and current regulatory landscape

Seminars in Arthritis and Rheumatism

Volumn 45, Issue 5, 2016, Pages S1-S10

  Olech, Ewa ^a  

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

Author keywords

Biologic; Biosimilar; Biosimilarity; Chronic inflammatory diseases; Development; Generics; Innovator; Nomenclature; Reference product; Regulatory guidance; Regulatory pathways; Small molecule drugs

Indexed keywords

BIOSIMILAR AGENT;

ARTICLE; BIOLOGICAL ACTIVITY; DRUG APPROVAL; DRUG EFFICACY; DRUG MANUFACTURE; DRUG MARKETING; DRUG QUALITY; DRUG SAFETY; EUROPEAN MEDICINES AGENCY; FOOD AND DRUG ADMINISTRATION; LICENSING; PRIORITY JOURNAL; WORLD HEALTH ORGANIZATION; DRUG DEVELOPMENT; DRUG INDUSTRY; HUMAN; LEGISLATION AND JURISPRUDENCE; RHEUMATIC DISEASES; UNITED STATES;

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

EID: 84961143811     PISSN: 00490172     EISSN: 1532866X     Source Type: Journal    
DOI: 10.1016/j.semarthrit.2016.01.001     Document Type: Article

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