Similar biological medicinal products: Lessons learned and challenges ahead

Journal of Generic Medicines

Volumn 8, Issue 1, 2011, Pages 4-13

  Ruiz, Sol ^a   Calvo, Gonzalo ^b  

^a EUROPEAN MEDICINES AGENCY   (United Kingdom)

^b UNIVERSITY OF BARCELONA   (Spain)

Author keywords

Biologicals; Biosimilar; Guidelines; Pharmacovigilance; Substitution

Indexed keywords

BETA INTERFERON; EFALIZUMAB; GENERIC DRUG; HUMAN GROWTH HORMONE; HUMAN INSULIN; MONOCLONAL ANTIBODY; NATALIZUMAB; RECOMBINANT ERYTHROPOIETIN; RECOMBINANT GRANULOCYTE COLONY STIMULATING FACTOR; ROTAVIRUS VACCINE;

ANEMIA; ARTICLE; COST EFFECTIVENESS ANALYSIS; DRUG APPROVAL; DRUG COST; DRUG EFFICACY; DRUG INDICATION; DRUG INDUSTRY; DRUG LEGISLATION; DRUG MARKETING; DRUG QUALITY; DRUG RESEARCH; DRUG SAFETY; DRUG SCREENING; DRUG SURVEILLANCE PROGRAM; ERYTHROCYTE APLASIA; EUROPEAN UNION; GOVERNMENT REGULATION; GROWTH RETARDATION; HUMAN; IMMUNOGENICITY; INTUSSUSCEPTION; KIDNEY INJURY; MULTIPLE SCLEROSIS; PROGRAM DEVELOPMENT; PROGRESSIVE MULTIFOCAL LEUKOENCEPHALOPATHY; PSORIASIS; RISK BENEFIT ANALYSIS; ROTAVIRUS INFECTION;

EID: 80054931403     PISSN: 17411343     EISSN: 17417090     Source Type: Journal    
DOI: 10.1057/jgm.2010.35     Document Type: Article

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