Clinical trial development for biosimilars

Seminars in Arthritis and Rheumatism

Volumn 44, Issue 6, 2015, Pages S2-S8

  Alten, Rieke ^a   Cronstein, Bruce N ^b  

^a CHARITÉ UNIVERSITÄTSMEDIZIN BERLIN   (Germany)

^b NEW YORK UNIVERSITY SCHOOL OF MEDICINE   (United States)

Author keywords

biologic; Biosimilar; chronic inflammatory diseases; clinical studies, comparability; immunogenicity, extrapolation; pharmacodynamics; pharmacokinetics; reference product; regulatory guidances; safety; study design

Indexed keywords

BIOSIMILAR AGENT; MONOCLONAL ANTIBODY;

ANKYLOSING SPONDYLITIS; CLINICAL OUTCOME; CLINICAL STUDY; CROHN DISEASE; DRUG APPROVAL; DRUG EFFICACY; DRUG POTENCY; DRUG SAFETY; EUROPEAN MEDICINES AGENCY; EUROPEAN UNION; FOOD AND DRUG ADMINISTRATION; HUMAN; INTENTION TO TREAT ANALYSIS; JUVENILE RHEUMATOID ARTHRITIS; PHARMACODYNAMICS; PHARMACOKINETIC PARAMETERS; PRACTICE GUIDELINE; PRIORITY JOURNAL; PSORIATIC ARTHRITIS; RESEARCH SUBJECT; REVIEW; RHEUMATOID ARTHRITIS; SAMPLE SIZE; STUDY DESIGN; ULCERATIVE COLITIS; UNITED STATES; ARTHRITIS; CLINICAL TRIAL (TOPIC); EPIDEMIOLOGY; INFLAMMATORY BOWEL DISEASES; LEGISLATION AND JURISPRUDENCE; PSORIASIS; STANDARDS;

ANTIBODIES, MONOCLONAL; ARTHRITIS; BIOSIMILAR PHARMACEUTICALS; CLINICAL TRIALS AS TOPIC; DRUG APPROVAL; EPIDEMIOLOGIC RESEARCH DESIGN; EUROPEAN UNION; HUMANS; INFLAMMATORY BOWEL DISEASES; PSORIASIS; UNITED STATES; UNITED STATES FOOD AND DRUG ADMINISTRATION;

EID: 84944325199     PISSN: 00490172     EISSN: 1532866X     Source Type: Journal    
DOI: 10.1016/j.semarthrit.2015.04.002     Document Type: Review

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