Waiving in vivo studies for monoclonal antibody biosimilar development: National and global challenges

mAbs

Volumn 8, Issue 3, 2016, Pages 427-435

  Chapman, Kathryn ^a   Adjei, Akosua ^b   Baldrick, Paul ^c   da Silva, Antonio ^d   De Smet, Karen ^e   DiCicco, Richard ^f   Hong, Seung Suh ^g   Jones, David ^b   Leach, Michael W ^h   McBlane, James ^b   Ragan, Ian ⁱ   Reddy, Praveen ^j   Stewart, Donald I H ^k   Suitters, Amanda ^l   Sims, Jennifer ^m  

^a National Centre for the Replacement   (United Kingdom)

^b MEDICINES AND HEALTHCARE PRODUCTS REGULATORY AGENCY   (United Kingdom)

^c Department of Genetic and Molecular Toxicology   (United Kingdom)

^d Sandoz Pharma Ltd   (Switzerland)

^e Federal Agency for Medical and Health Products (FAMHP)   (Belgium)

^f Harvest Moon Pharmaceuticals   (United States)

^g Celltrion   (Japan)

^h PFIZER INC   (United States)

ⁱ Independent   (United Kingdom)

^j Biocon   (India)

^k PlantForm Corp   (Canada)

^l Paraxel   (United Kingdom)

^m Integrated Biologix   (Switzerland)

more..

Author keywords

3Rs; Biosimilar; development; EMA; FDA; guidelines; in vitro; in vivo; regulatory; study design; WHO

Indexed keywords

BIOSIMILAR AGENT; FILGRASTIM; INFLIXIMAB; MONOCLONAL ANTIBODY;

ARTICLE; CLINICAL DEVELOPMENT PLAN; CLINICAL TRIAL (TOPIC); DRUG DOSE ESCALATION; DRUG MARKETING; FOOD AND DRUG ADMINISTRATION; HUMAN; NONHUMAN; PRACTICE GUIDELINE; REGULATORY MECHANISM; TOXICITY ASSAY; WORLD HEALTH ORGANIZATION; ANIMAL; DRUG APPROVAL; LEGISLATION AND JURISPRUDENCE; PRECLINICAL STUDY; PROCEDURES; TRENDS; UNITED STATES;

ANIMALS; ANTIBODIES, MONOCLONAL; BIOSIMILAR PHARMACEUTICALS; DRUG APPROVAL; DRUG EVALUATION, PRECLINICAL; HUMANS; UNITED STATES; UNITED STATES FOOD AND DRUG ADMINISTRATION;

EID: 84961620659     PISSN: 19420862     EISSN: 19420870     Source Type: Journal    
DOI: 10.1080/19420862.2016.1145331     Document Type: Article

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