Biosimilars 2.0: Guiding principles for a global "patients first" standard

mAbs

Volumn 3, Issue 3, 2011, Pages 318-325

  Miletich, Joseph ^a   Eich, Geoffrey ^a   Grampp, Gustavo ^b   Mounho, Barbara ^a  

^a AMGEN INC   (United States)

^b NONE

Author keywords

Biosimilars; Biotechnology; Generic drugs; Monoclonal antibodies; Pharmacodynamics; Pharmacokinetics

Indexed keywords

BIOLOGICAL PRODUCT; HUMAN GROWTH HORMONE; HUMAN INSULIN; HYBRID PROTEIN; INSULIN; MONOCLONAL ANTIBODY; RECOMBINANT ALPHA2A INTERFERON; RECOMBINANT ERYTHROPOIETIN; RECOMBINANT GRANULOCYTE COLONY STIMULATING FACTOR;

BIOTECHNOLOGY; DRUG APPROVAL; DRUG EFFICACY; DRUG INDUSTRY; DRUG MANUFACTURE; DRUG QUALITY; DRUG SAFETY; GOVERNMENT REGULATION; IMMUNOGENICITY; PRACTICE GUIDELINE; REVIEW;

BIOLOGICAL AGENTS; DRUG APPROVAL; DRUG INDUSTRY; DRUG MONITORING; DRUG THERAPY; EUROPEAN UNION; HUMANS; LEGISLATION, DRUG;

EID: 79955655456     PISSN: 19420862     EISSN: 19420870     Source Type: Journal    
DOI: 10.4161/mabs.3.3.15599     Document Type: Review

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