Review, approval, and marketing of biosimilars in the united states - Part 1: Safety and regulatory issues

BioProcess International

Volumn 8, Issue 11, 2010, Pages 12-20

  Aagaard, Amber W ^a   Purdy, Serena ^b   Philpott, Sean ^b  

^a Teleflex Medical   (United States)

^b CLARKSON UNIVERSITY   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

BETA1A INTERFERON; BIOLOGICAL PRODUCT; CELL THERAPY AGENT; FILGRASTIN; FILGRASTIN HECAL; GENE THERAPY AGENT; HUMAN GROWTH HORMONE; HUMAN SERUM ALBUMIN; INSULIN; INTERFERON BETA SERINE; MONOCLONAL ANTIBODY; MONOCLONAL ANTIBODY TGN1412; POLYSORBATE 80; RECOMBINANT ALPHA2A INTERFERON; RECOMBINANT ERYTHROPOIETIN; RECOMBINANT GRANULOCYTE COLONY STIMULATING FACTOR; RECOMBINANT HUMAN INSULIN; RECOMBINANT INTERFERON; RETOCRIT; UNCLASSIFIED DRUG;

ANEMIA; BIOEQUIVALENCE; BIOPROCESS; BRAIN HEMORRHAGE; CHRONIC LYMPHATIC LEUKEMIA; CLINICAL TRIAL (TOPIC); CURRENT GOOD MANUFACTURING PRACTICE; DRUG APPROVAL; DRUG COST; DRUG EFFICACY; DRUG FORMULATION; DRUG HYPERSENSITIVITY; DRUG INDUSTRY; DRUG LEGISLATION; DRUG MANUFACTURE; DRUG MARKETING; DRUG POTENCY; DRUG SAFETY; EUROPEAN MEDICINE AGENCY; FOOD AND DRUG ADMINISTRATION; GOOD MANUFACTURING PRACTICE; HEALTH CARE ORGANIZATION; HEALTH CARE SYSTEM; HEPATITIS C; HUMAN; IMMUNOGENICITY; IMMUNOMODULATION; MULTIPLE SCLEROSIS; NONHUMAN; PATENT; PHARMACODYNAMICS; PHASE 1 CLINICAL TRIAL (TOPIC); POSTMARKETING SURVEILLANCE; PRESCRIPTION; PURE RED CELL ANEMIA; REVIEW; RHEUMATOID ARTHRITIS; RISK ASSESSMENT; SYSTEMIC INFLAMMATORY RESPONSE SYNDROME; UNITED STATES; UNSPECIFIED SIDE EFFECT;

EID: 78650346632     PISSN: 15426319     EISSN: None     Source Type: Trade Journal    
DOI: None     Document Type: Review

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