Next generation and biosimilar monoclonal antibodies: Essential considerations towards regulatory acceptance in Europe - February 3-4, 2011, Freiburg, Germany

mAbs

Volumn 3, Issue 3, 2011, Pages 223-240

  Reichert, Janice M ^a  

^a Landes Bioscience   (United States)

Author keywords

Biosimilar; European Medicines Agency; Medicinal product regulation; Monoclonal antibody

Indexed keywords

ABCIXIMAB; ADALIMUMAB; ALEMTUZUMAB; BASILIXIMAB; BEVACIZUMAB; CANAKINUMAB; CATUMAXOMAB; CERTOLIZUMAB PEGOL; CETUXIMAB; DACLIZUMAB; ECULIZUMAB; EFALIZUMAB; GEMTUZUMAB OZOGAMICIN; GOLIMUMAB; IBRITUMOMAB TIUXETAN; INFLIXIMAB; METHOTREXATE; MONOCLONAL ANTIBODY; NATALIZUMAB; OKT 3; OMALIZUMAB; PALIVIZUMAB; PANITUMUMAB; RANIBIZUMAB; RITUXIMAB; TGN 1412; TOSITUMOMAB I 131; TRASTUZUMAB; UNINDEXED DRUG; USTEKINUMAB;

ACUTE GRANULOCYTIC LEUKEMIA; ANKYLOSING SPONDYLITIS; ASCITES; ASTHMA; AUTOIMMUNE DISEASE; B CELL LEUKEMIA; BREAST CANCER; CHRONIC MYELOID LEUKEMIA; CLINICAL TRIAL (TOPIC); COLORECTAL CANCER; CONFERENCE PAPER; CROHN DISEASE; DRUG APPROVAL; DRUG INDICATION; DRUG INDUCED CANCER; DRUG INDUCED DISEASE; DRUG INFUSION REACTION; DRUG MARKETING; DRUG SAFETY; EUROPE; EUROPEAN UNION; GERMANY; GOVERNMENT REGULATION; HUMAN; IMMUNOGENICITY; INFECTION; JUVENILE RHEUMATOID ARTHRITIS; KIDNEY GRAFT REJECTION; LYMPHOMA; MALIGNANT ASCITES; MALIGNANT NEOPLASTIC DISEASE; MUCKLE WELLS SYNDROME; MULTIPLE SCLEROSIS; NONHODGKIN LYMPHOMA; NONHUMAN; OPPORTUNISTIC INFECTION; PAROXYSMAL NOCTURNAL HEMOGLOBINURIA; PRACTICE GUIDELINE; PROGRESSIVE MULTIFOCAL LEUKOENCEPHALOPATHY; PSORIASIS; PSORIATIC ARTHRITIS; RESPIRATORY SYNCYTIAL VIRUS INFECTION; RETINA MACULA DEGENERATION; RHEUMATOID ARTHRITIS; SEPSIS; THROMBOSIS PREVENTION; TUBERCULOSIS; ULCERATIVE COLITIS; UNSPECIFIED SIDE EFFECT; WORLD HEALTH ORGANIZATION;

ANIMALS; ANTIBODIES, MONOCLONAL; BIOLOGICAL AGENTS; CHEMISTRY, PHARMACEUTICAL; DRUG APPROVAL; DRUG INDUSTRY; EUROPE; HUMANS;

EID: 79955675294     PISSN: 19420862     EISSN: 19420870     Source Type: Journal    
DOI: 10.4161/mabs.3.3.15475     Document Type: Conference Paper

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