Biosimilars: Impact of Biologic Product Life Cycle and European Experience on the Regulatory Trajectory in the United States

Clinical Therapeutics

Volumn 34, Issue 2, 2012, Pages 400-419

  Ahmed, Islah ^a   Kaspar, Ben ^b   Sharma, Uma ^b  

^a Hospira Inc   (United States)

^b MMS HOLDINGS INC   (United States)

Author keywords

Biologics manufacturing; Biosimilar regulations; Biosimilars

Indexed keywords

BIOSIMILAR AGENT; COMPLEMENTARY DNA; GENERIC DRUG; GLYCERYL TRINITRATE; HUMAN GROWTH HORMONE; HUMAN INSULIN; RECOMBINANT ALPHA2A INTERFERON; RECOMBINANT ERYTHROPOIETIN; RECOMBINANT GRANULOCYTE COLONY STIMULATING FACTOR;

ARTICLE; BACULOVIRUS; BIOEQUIVALENCE; BIOPHYSICS; BIOREACTOR; BODY HEIGHT; BREAST CANCER; CELL CULTURE; DEAMINATION; DOSE RESPONSE; DRUG FORMULATION; DRUG LEGISLATION; DRUG MANUFACTURE; DRUG MARKETING; DRUG POTENCY; DRUG PURIFICATION; DRUG SAFETY; DRUG TOLERABILITY; EMBASE; ESCHERICHIA COLI; FOOD AND DRUG ADMINISTRATION; FRAGMENTATION REACTION; GENE EXPRESSION; GENE MUTATION; HEALTH PROGRAM; HUMAN; MAMMAL CELL; MEDICAL SOCIETY; MEDLINE; NEUTROPENIA; NONHUMAN; OXIDATION; PLASMID; PRACTICE GUIDELINE; REDUCTION; UNITED STATES; WORLD HEALTH ORGANIZATION; YEAST;

BIOLOGICAL AGENTS; DRUG AND NARCOTIC CONTROL; EUROPE; GUIDELINES AS TOPIC; UNITED STATES;

EID: 84856710491     PISSN: 01492918     EISSN: 1879114X     Source Type: Journal    
DOI: 10.1016/j.clinthera.2011.12.005     Document Type: Article

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