Intended use of Reference Products & WHO International Standards/Reference Reagents in the development of Similar Biological Products (Biosimilars)

Biologicals

Volumn 39, Issue 5, 2011, Pages 262-265

  Thorpe, Robin ^a   Wadhwa, Meenu ^a  

^a NATIONAL INSTITUTE FOR BIOLOGICAL STANDARDS AND CONTROL   (United Kingdom)

Author keywords

Bioassay; Comparability studies; Potency; Reference product; WHO International Standard reference reagents

Indexed keywords

ALPHA 1 ANTITRYPSIN; ALPHA2A INTERFERON; ALPHA2B INTERFERON; ANTITHROMBIN; BETA INTERFERON; BIOLOGICAL PRODUCT; BLOOD CLOTTING FACTOR 13; BLOOD CLOTTING FACTOR 7; BLOOD CLOTTING FACTOR 7A; BLOOD CLOTTING FACTOR 8; BLOOD CLOTTING FACTOR 9; BLOOD CLOTTING FACTOR 9A; CALCITONIN; CHORIONIC GONADOTROPIN; COLONY STIMULATING FACTOR 1; FOLLITROPIN; GRANULOCYTE COLONY STIMULATING FACTOR; GROWTH HORMONE; HUMAN INSULIN; INTERLEUKIN 11; INTERLEUKIN 2; LOW MOLECULAR WEIGHT HEPARIN; LUTEINIZING HORMONE; PARATHYROID HORMONE; PROLACTIN; RECOMBINANT ERYTHROPOIETIN; REFERENCE PRODUCT; RIBOSOME DNA; SIMILAR BIOTHERAPEUTIC PRODUCT; UNCLASSIFIED DRUG; UNINDEXED DRUG;

ANALYTIC METHOD; ARTICLE; BIOASSAY; CALIBRATION; DRUG APPROVAL; DRUG EFFICACY; DRUG MANUFACTURE; DRUG MARKETING; DRUG QUALITY; DRUG SAFETY; DRUG SCREENING; PRIORITY JOURNAL; STANDARD; WORLD HEALTH ORGANIZATION;

DRUG INDUSTRY; LEGISLATION, DRUG; PHARMACEUTICAL PREPARATIONS; REFERENCE STANDARDS; WORLD HEALTH ORGANIZATION;

EID: 80053572216     PISSN: 10451056     EISSN: 10958320     Source Type: Journal    
DOI: 10.1016/j.biologicals.2011.06.005     Document Type: Article

References (7)

1. European Medicines Agency guideline on similar biological medicinal products 2005, Available at:. http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/09/WC500003517.pdf.
2. European Medicines Agency guideline on similar biological medicinal products containing biotechnology-derived proteins as active substance: quality issues 2006, Available at:. http://www.emea.europa.eu/pdfs/human/biosimilar/4934805en.pdf.
3. European Medicines Agency guideline on similar biological medicinal products containing biotechnology-derived proteins as active substance: non-clinical and clinical issues 2006, Available at:. http://www.emea.europa.eu/pdfs/human/biosimilar/4283205en.pdf.
4. WHO guidelines on evaluation of similar biotherapeutic products (SBPs) 19-23 October 2009, World Health Organisation Expert Committee on Biological Standardization, Geneva, Available at:. http://www.who.int/biologicals/areas/biological_therapeutics/BIOTHERAPEUTICS_FOR_WEB_22APRIL2010.pdf.
5. Recommendations for the preparation, characterization and establishment of international and other biological reference standards (revised 2004), WHO ECBS Fifty-fifth Report. WHO technical report series 2006, vol. 932. p. 73-131.
6. Wadhwa M., Bird C., Hamill M., Heath A.B., Matejtschuk P., Thorpe R., et al. The 2nd international standard for human granulocyte colony stimulating factor. Journal of Immunological Methods 2011, 367:63-69.
7. Thorpe R., Wadhwa M., Mire-Sluis A. The use of bioassays for the characterisation and control of biological therapeutic products produced by biotechnology. Developments in Biological Standardisation 1997, 91:79-88.