Clinical and regulatory perspectives on biosimilar therapies and intended copies of biologics in rheumatology

Rheumatology International

Volumn 36, Issue 5, 2016, Pages 613-625

  Mysler, Eduardo ^a   Pineda, Carlos ^b   Horiuchi, Takahiko ^c   Singh, Ena ^d   Mahgoub, Ehab ^d   Coindreau, Javier ^d   Jacobs, Ira ^d  

^a Reumatólogo en Organización Médica de Investigación ^*  (Argentina)

^b INSTITUTO NACIONAL DE REHABILITACIÓN   (Mexico)

^c KYUSHU UNIVERSITY BEPPU HOSPITAL   (Japan)

^d PFIZER INC   (United States)

Author keywords

Biologic; Biosimilar; Intended copy; Pharmacovigilance; Regulatory

Indexed keywords

BIOLOGICAL PRODUCT; BIOSIMILAR AGENT; INTENDED COPY BIOLOGIC AGENT; PROTEIN; UNCLASSIFIED DRUG;

BIOLOGICAL THERAPY; CLINICAL TRIAL (TOPIC); COMPARATIVE STUDY; DRUG MANUFACTURE; DRUG SURVEILLANCE PROGRAM; HUMAN; MEDICAL DECISION MAKING; MUSCULOSKELETAL DISEASE; PRIORITY JOURNAL; REVIEW; RHEUMATIC DISEASE; RHEUMATOLOGY; RISK MANAGEMENT; RHEUMATIC DISEASES; THERAPEUTIC EQUIVALENCE;

BIOLOGICAL PRODUCTS; BIOSIMILAR PHARMACEUTICALS; HUMANS; RHEUMATIC DISEASES; RHEUMATOLOGY; THERAPEUTIC EQUIVALENCY;

EID: 84964262382     PISSN: 01728172     EISSN: 1437160X     Source Type: Journal    
DOI: 10.1007/s00296-016-3444-0     Document Type: Review

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