Biosimilars of biological drug therapies: Regulatory, clinical and commercial considerations

Drugs

Volumn 71, Issue 12, 2011, Pages 1527-1536

  Dranitsaris, George ^a   Amir, Eitan ^b   Dorward, Kristine ^c  

^a Augmentium Pharma Consulting   (Canada)

^b PRINCESS MARGARET HOSPITAL   (Canada)

^c UNIVERSITY OF MANCHESTER   (United Kingdom)

Author keywords

Biological peptides; Generic drugs; Regulatory process.

Indexed keywords

ABATACEPT; ALPHA INTERFERON; BASILIXIMAB; BEVACIZUMAB; BIOLOGICAL PRODUCT; BIOSIMILAR AGENT; CETUXIMAB; CRESP; DACLIZUMAB; ERYTHROPOIETIN; ETANERCEPT; FOLLITROPIN; GRAFEEL; GRANULOCYTE COLONY STIMULATING FACTOR; HUMAN GROWTH HORMONE; INFLIXIMAB; INSULIN; INSULIN GLARGINE; INTERFERON; LOW MOLECULAR WEIGHT HEPARIN; MONOCLONAL ANTIBODY; NOVEL ERYTHROPOIESIS STIMULATING PROTEIN; OKT 3; PEGINTERFERON; RECOMBINANT ERYTHROPOIETIN; RECOMBINANT GRANULOCYTE COLONY STIMULATING FACTOR; REDITUX; RITUXIMAB; STREPTOKINASE; TEPLIZUMAB; TISSUE PLASMINOGEN ACTIVATOR; TRASTUZUMAB; UNCLASSIFIED DRUG;

COMMERCIAL PHENOMENA; DRUG APPROVAL; DRUG COST; DRUG EFFICACY; DRUG QUALITY; DRUG SAFETY; EUROPEAN UNION; HUMAN; IMMUNOGENICITY; PATENT; PRACTICE GUIDELINE; QUALITY CONTROL; REVIEW;

BIOPHARMACEUTICS; BIOSIMILAR PHARMACEUTICALS; DRUG AND NARCOTIC CONTROL; DRUG APPROVAL; DRUGS, GENERIC; HUMANS; PATENTS AS TOPIC; RECOMBINANT PROTEINS; THERAPEUTIC EQUIVALENCY;

EID: 80051984166     PISSN: 00126667     EISSN: 11791950     Source Type: Journal    
DOI: 10.2165/11593730-000000000-00000     Document Type: Review

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