The role of the quality assessment in the determination of overall biosimilarity: A simulated case study exercise

Biologicals

Volumn 42, Issue 2, 2014, Pages 128-132

  Schiestl, Martin ^a   Li, Jing ^b   Abas, Arpah ^c   Vallin, Antonio ^d   Millband, Jennifer ^e   Gao, Kai ^f   Joung, Jeewon ^g   Pluschkell, Stefanie ^h   Go, Thomas ⁱ   Kang, Hye Na ^j  

^a NOVARTIS PHARMA AG   (Switzerland)

^b Shanghai Allist Pharmaceut Co Inc   (China)

^c MINISTRY OF HEALTH   (Malaysia)

^d CENTER OF MOLECULAR IMMUNOLOGY   (Cuba)

^e National Institute for Food and Drug Control ^*

^f NATIONAL INSTITUTES FOR FOOD AND DRUG CONTROL   (China)

^g Korea Food and Drug Administration   (South Korea)

^h PFIZER INC   (United States)

ⁱ Health Products Regulation Group (HPRG)   (Singapore)

^j WORLD HEALTH ORGANIZATION   (Switzerland)

more..

Author keywords

Biosimilar; Quality assessment; Similar biotherapeutic products; WHO; Xiamen case study

Indexed keywords

GLYCAN; MONOCLONAL ANTIBODY; BIOLOGICAL PRODUCT;

ANALYTIC METHOD; ARTICLE; BIOSIMILARITY; CASE STUDY; CHINA; IMMUNOGENICITY; PRACTICE GUIDELINE; PRIORITY JOURNAL; QUALITY CONTROL; SIMULATION; WORKSHOP; WORLD HEALTH ORGANIZATION; STANDARDS;

BIOLOGICAL PRODUCTS; QUALITY CONTROL;

EID: 84896495229     PISSN: 10451056     EISSN: 10958320     Source Type: Journal    
DOI: 10.1016/j.biologicals.2013.11.009     Document Type: Article

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