Case studies on clinical evaluation of biosimilar monoclonal antibody: Scientific considerations for regulatory approval

Biologicals

Volumn 43, Issue 1, 2015, Pages 1-10

  Kudrin, Alex ^a   Knezevic, Ivana ^c   Joung, Jeewon ^b   Kang, Hye Na ^c  

^a Celltrion Inc   (South Korea)

^b National Institute of Food and Drug Safety Evaluation   (South Korea)

^c WORLD HEALTH ORGANIZATION   (Switzerland)

Author keywords

Biosimilar; Clinical assessment; Equivalence; Extrapolation; Similar biotherapeutic products; WHO

Indexed keywords

AZATHIOPRINE; BIOSIMILAR AGENT; CORTICOSTEROID; DISEASE MODIFYING ANTIRHEUMATIC DRUG; IMMUNOSUPPRESSIVE AGENT; INFLIXIMAB; MERCAPTOPURINE; METHOTREXATE; OBINUTUZUMAB; OCRELIZUMAB; PLACEBO; RITUXIMAB; MONOCLONAL ANTIBODY;

ANKYLOSING SPONDYLITIS; BIOEQUIVALENCE; CASE STUDY; CHRONIC LYMPHATIC LEUKEMIA; CLINICAL ASSESSMENT; CLINICAL EVALUATION; CROHN DISEASE; DRUG APPROVAL; DRUG MANUFACTURE; DRUG MECHANISM; HUMAN; INFECTION; INFUSION RELATED REACTION; MULTIPLE CYCLE TREATMENT; NEUTROPENIA; NONHODGKIN LYMPHOMA; PRACTICE GUIDELINE; PSORIASIS; PSORIATIC ARTHRITIS; RANDOMIZED CONTROLLED TRIAL (TOPIC); REVIEW; RHEUMATOID ARTHRITIS; SINGLE DRUG DOSE; ULCERATIVE COLITIS; UNSPECIFIED SIDE EFFECT; WORLD HEALTH ORGANIZATION; SOUTH KOREA;

ANTIBODIES, MONOCLONAL; HUMANS; REPUBLIC OF KOREA; WORLD HEALTH ORGANIZATION;

EID: 84921609595     PISSN: 10451056     EISSN: 10958320     Source Type: Journal    
DOI: 10.1016/j.biologicals.2014.11.002     Document Type: Review

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