Equivalence of complex drug products: advances in and challenges for current regulatory frameworks

Annals of the New York Academy of Sciences

Volumn 1407, Issue 1, 2017, Pages 39-49

  Hussaarts, Leonie ^k   Mühlebach, Stefan ^a   Shah, Vinod P ^b   McNeil, Scott ^c   Borchard, Gerrit ^d   Flühmann, Beat ^a   Weinstein, Vera ^e   Neervannan, Sesha ^f   Griffiths, Elwyn ^g   Jiang, Wenlei ^h   Wolff Holz, Elena ⁱ   Crommelin, Daan J A ^j   de Vlieger, Jon S B ^k  

^a Vifor (International) Inc   (Switzerland)

^b Pharmaceutical Consultant   (United States)

^c Nanotechnology Characterization Laboratory   (United States)

^d UNIVERSITY OF GENEVA   (Switzerland)

^e TEVA PHARMACEUTICALS   (Israel)

^f Allergen Plc   (United States)

^g Member of the WHO Advisory Panel on Biological Standardization   (United Kingdom)

^h CENTER FOR DRUG EVALUATION AND RESEARCH   (United States)

ⁱ PAUL EHRLICH INSTITUT   (Germany)

^j UTRECHT UNIVERSITY   (Netherlands)

^k NONE

more..

Author keywords

biosimilar; complex drug; EMA; FDA; generics; nonbiological complex drugs (NBCDs); pharmaceutical; regulatory science; therapeutic equivalency

Indexed keywords

BIOLOGICAL PRODUCT; GENERIC DRUG;

ARTICLE; CLINICAL PRACTICE; DRUG EFFICACY; DRUG LABELING; DRUG LEGISLATION; DRUG NOMENCLATURE; DRUG QUALITY; DRUG SAFETY; DRUG SURVEILLANCE PROGRAM; EUROPE; EUROPEAN MEDICINES AGENCY; FOLLOW UP; FOOD AND DRUG ADMINISTRATION; HUMAN; MEDICAL SOCIETY; NONHUMAN; SCIENTIST; THERAPEUTIC EQUIVALENCE; UNITED STATES; WORLD HEALTH ORGANIZATION; DRUG APPROVAL; NANOMEDICINE; PROCEDURES; STANDARDS;

BIOLOGICAL PRODUCTS; DRUG APPROVAL; DRUGS, GENERIC; EUROPE; HUMANS; NANOMEDICINE; THERAPEUTIC EQUIVALENCY; UNITED STATES; UNITED STATES FOOD AND DRUG ADMINISTRATION; WORLD HEALTH ORGANIZATION;

EID: 85018447172     PISSN: 00778923     EISSN: 17496632     Source Type: Journal    
DOI: 10.1111/nyas.13347     Document Type: Article

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