Biosimilarity Versus Manufacturing Change: Two Distinct Concepts

Pharmaceutical Research

Volumn 33, Issue 2, 2016, Pages 261-268

  Declerck, Paul ^a   Farouk Rezk, Mourad ^b,c   Rudd, Pauline M ^d  

^a UNIVERSITY OF LEUVEN   (Belgium)

^b AMGEN INC   (United States)

^c Biogen Idec International GmbH   (Switzerland)

^d NATIONAL INSTITUTE FOR BIOPROCESSING RESEARCH AND TRAINING   (Ireland)

Author keywords

biologics; biosimilarity; biosimilars; comparability

Indexed keywords

BIOSIMILAR AGENT;

DRUG APPROVAL; DRUG EFFICACY; DRUG FORMULATION; DRUG LEGISLATION; DRUG MANUFACTURE; DRUG PURIFICATION; DRUG QUALITY; DRUG SAFETY; EUROPE; HUMAN; NONHUMAN; PHASE 3 CLINICAL TRIAL (TOPIC); PRIORITY JOURNAL; REVIEW; STUDY; ANIMAL; CHEMISTRY; DRUG DEVELOPMENT; DRUG INDUSTRY; PROCEDURES;

ANIMALS; BIOSIMILAR PHARMACEUTICALS; DRUG APPROVAL; DRUG DISCOVERY; DRUG INDUSTRY; HUMANS;

EID: 84954373848     PISSN: 07248741     EISSN: 1573904X     Source Type: Journal    
DOI: 10.1007/s11095-015-1790-3     Document Type: Review

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