Biosimilars need comparative clinical data

Kidney International

Volumn 80, Issue 5, 2011, Pages 553-

  Casadevall, Nicole ^a   Thorpe, Robin ^b   Schellekens, Huub ^c  

^a HÔPITAL SAINT ANTOINE   (France)

^b NIBSC HPA   (United Kingdom)

^c UTRECHT UNIVERSITY   (Netherlands)

Author keywords

[No Author keywords available]

Indexed keywords

BIOSIMILAR AGENT; RECOMBINANT ERYTHROPOIETIN; ERYTHROPOIETIN; NEUTRALIZING ANTIBODY;

CONSENSUS DEVELOPMENT; DISEASE ASSOCIATION; DRUG APPROVAL; DRUG INFORMATION; DRUG MARKETING; HUMAN; IMMUNOGENICITY; INFORMATION PROCESSING; LETTER; MEDICAL RESEARCH; PRACTICE GUIDELINE; PRIORITY JOURNAL; PURE RED CELL ANEMIA; QUALITY CONTROL; THAILAND; WORLD HEALTH ORGANIZATION; ANEMIA; BIOSYNTHESIS; FEMALE; IMMUNOLOGY; MALE; NOTE;

ANEMIA; ANTIBODIES, NEUTRALIZING; ERYTHROPOIETIN; FEMALE; HUMANS; MALE;

EID: 84857094400     PISSN: 00852538     EISSN: 15231755     Source Type: Journal    
DOI: 10.1038/ki.2011.164     Document Type: Letter

References (2)

1. Praditpornsilpa K, Tiranathanagul K, Kupatawintu P et al. Biosimilar recombinant human erythropoietin induces the production of neutralizing antibodies. Kidney Int 2011; 80: 88-92.
2. Joung J, Robertson JS, Griffiths E, et al., WHO Informal Consultation Group. WHO informal consultation on regulatory evaluation of therapeutic biological medicinal products held at WHO Headquarters, Geneva, 19-20 April 2007. Biologicals 2008; 36: 269-276.