Legislative initiatives in Europe, Canada and the US for market authorization of follow-on biologics

Current Opinion in Drug Discovery and Development

Volumn 13, Issue 2, 2010, Pages 247-256

  Looper, Ywe J ^a  

^a BOEHRINGER INGELHEIM CANADA LTD   (Canada)

Author keywords

Biosimilar; Canada; Europe; Follow on biologic; Legislative initiative; Regulatory guideline; Subsequent entry biologic; US

Indexed keywords

ABSEAMED; ALLERGEN; ALPHA2A INTERFERON; ALPHA2B INTERFERON; BIOGRASTIM; BIOLOGICAL PRODUCT; CALCITONIN; EPOETIN ALFA HEXAL; EPROGEN; EUTROPIN; FILGRASTIM HEXAL; FILGRASTIM RATIOPHARM; GENERIC DRUG; GLUCAGON; HUMAN GROWTH HORMONE; HYALURONIDASE; RATIOGRASTIM; RECOMBINANT ERYTHROPOIETIN; RECOMBINANT GRANULOCYTE COLONY STIMULATING FACTOR; RECOMBINANT HUMAN INSULIN; TEVAGRASTIM; UNCLASSIFIED DRUG; VACCINE; ZARZIO;

BIOLOGICAL THERAPY; CANADA; DRUG EFFICACY; DRUG LEGISLATION; DRUG MARKETING; DRUG PURITY; DRUG QUALITY; DRUG SAFETY; EUROPE; HUMAN; PATENT; PRACTICE GUIDELINE; REVIEW; UNITED STATES;

BIOLOGICAL PRODUCTS; CANADA; CLINICAL TRIALS AS TOPIC; DRUG APPROVAL; DRUG DESIGN; EUROPE; GUIDELINES AS TOPIC; HUMANS; LEGISLATION, DRUG; PRODUCT SURVEILLANCE, POSTMARKETING; UNITED STATES;

EID: 77749277255     PISSN: 13676733     EISSN: None     Source Type: Journal    
DOI: None     Document Type: Review

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