Biosimilars: The science of extrapolation

Blood

Volumn 124, Issue 22, 2014, Pages 3191-3196

  Weise, Martina ^a   Kurki, Pekka ^b   Wolff Holz, Elena ^c   Bielsky, Marie Christine ^d   Schneider, Christian K ^e,f  

^a FEDERAL INSTITUTE FOR DRUGS AND MEDICAL DEVICES   (Germany)

^b Finnish Medicines Agency   (Finland)

^c PAUL EHRLICH INSTITUT   (Germany)

^d MEDICINES AND HEALTHCARE PRODUCTS REGULATORY AGENCY   (United Kingdom)

^e Danish Health and Medicines Authority   (Denmark)

^f INSTITUTE OF INFECTION IMMUNOLOGY   (Germany)

Author keywords

[No Author keywords available]

Indexed keywords

BIOSIMILAR AGENT; INFLIXIMAB; RECOMBINANT ERYTHROPOIETIN; RECOMBINANT GRANULOCYTE COLONY STIMULATING FACTOR; RITUXIMAB; TRASTUZUMAB; ERYTHROPOIETIN; FILGRASTIM; GRANULOCYTE COLONY STIMULATING FACTOR; MONOCLONAL ANTIBODY; RECOMBINANT PROTEIN;

ANKYLOSING SPONDYLITIS; ANTIBODY DEPENDENT CELLULAR CYTOTOXICITY; CHEMOTHERAPY INDUCED ANEMIA; COMPLEMENT DEPENDENT CYTOTOXICITY; DRUG MARKETING; DRUG MECHANISM; DRUG SAFETY; DRUG STRUCTURE; EUROPEAN UNION; GENE EXPRESSION SYSTEM; GOVERNMENT REGULATION; HUMAN; IMMUNOGENICITY; INFLAMMATORY BOWEL DISEASE; NEUTROPENIA; NONHUMAN; PURE RED CELL ANEMIA; REVIEW; RHEUMATOID ARTHRITIS; STEM CELL MOBILIZATION; DRUG DESIGN; DRUG SCREENING; PATIENT SAFETY; STATISTICAL ANALYSIS; STATISTICS AND NUMERICAL DATA; SYNTHESIS; TREATMENT OUTCOME;

ANTIBODIES, MONOCLONAL; BIOSIMILAR PHARMACEUTICALS; DATA INTERPRETATION, STATISTICAL; DRUG DESIGN; DRUG EVALUATION, PRECLINICAL; ERYTHROPOIETIN; GRANULOCYTE COLONY-STIMULATING FACTOR; HUMANS; PATIENT SAFETY; RECOMBINANT PROTEINS; TREATMENT OUTCOME;

EID: 84911401436     PISSN: 00064971     EISSN: 15280020     Source Type: Journal    
DOI: 10.1182/blood-2014-06-583617     Document Type: Review

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