Assessing the bioequivalence of biosimilars. The Retacrit® case

Drug Discovery Today

Volumn 14, Issue 9-10, 2009, Pages 495-499

  Schellekens, H ^a  

^a UTRECHT UNIVERSITY   (Netherlands)

Author keywords

[No Author keywords available]

Indexed keywords

ABSEAMED; BINOCRIT; BIOLOGICAL PRODUCT; BIOSIMILAR; EPOETIN ZETA; GENERIC DRUG; HEXAL; RECOMBINANT CYTOKINE; RECOMBINANT ERYTHROPOIETIN; RETACRIT; SILAPO; UNCLASSIFIED DRUG;

BIOEQUIVALENCE; BIOMEDICINE; BIOTECHNOLOGY; BLOOD SAMPLING; CELL SORTER; CLINICAL STUDY; CLINICAL TRIAL; DRUG ABSORPTION; DRUG APPROVAL; DRUG BIOAVAILABILITY; DRUG EFFICACY; DRUG INFORMATION; DRUG LABELING; DRUG LEGISLATION; DRUG MANUFACTURE; DRUG MARKETING; DRUG POTENCY; DRUG PURITY; DRUG QUALITY; DRUG SAFETY; DRUG SCREENING; ENZYME LINKED IMMUNOSORBENT ASSAY; GOVERNMENT REGULATION; HUMAN; INTERNATIONAL STANDARD UNIT; PRACTICE GUIDELINE; PROTEIN ANALYSIS; PROTEIN PURIFICATION; RETICULOCYTE; REVIEW;

ANIMALS; BIOLOGICAL PRODUCTS; CLINICAL TRIALS AS TOPIC; DRUG EVALUATION, PRECLINICAL; DRUGS, GENERIC; EPOETIN ALFA; ERYTHROPOIETIN, RECOMBINANT; GUIDELINES AS TOPIC; HUMANS; PROTEINS; THERAPEUTIC EQUIVALENCY;

EID: 67349221747     PISSN: 13596446     EISSN: None     Source Type: Journal    
DOI: 10.1016/j.drudis.2009.02.003     Document Type: Review

References (22)

1. Crommelin D.J., et al. Pharmaceutical evaluation of biosimilars: important differences from generic low-molecular weight pharmaceuticals. Eur. J. Hosp. Pharm. Sci. 1 (2005) 11-17
2. Chirino A.J., and Mire-Sluis A. Characterizing biological products and assessing comparability following manufacturing changes. Nat. Biotechnol. 22 (2004) 1383-1391
3. European Parliament and Council. Directive 2004/27/EC of the European Parliament and of the Council of 31 March 2004. Official J. Eur. Union 47 (2004) 34-57
4. European Medicines Agency (2005) Guideline on similar biological medicinal products (http://www.emea.europa.eu/pdfs/human/biosimilar/043704en.pdf)
5. European Medicines Agency (2006) Guideline on similar biological medicinal products containing biotechnology-derived proteins as active substance: Quality issues (http://www.emea.europa.eu/pdfs/human/biosimilar/4934805en.pdf)
6. European Medicines Agency (2006) Guideline on similar biological medicinal products containing biotechnology-derived proteins as active substance: non-clinical and clinical issues (http://www.emea.eu.int/pdfs/human/biosimilar/4283205en.pdf)
7. European Medicines Agency (2006) Annex to guideline on similar biological medicinal products containing biotechnology-derived proteins as active substance: Non-clinical and clinical issues. Guidance on similar medicinal products containing recombinant erythropoietins (http://www.emea.europa.eu/pdfs/human/biosimilar/9452605en.pdf)
8. European Medicines Agency (2006) Annex to guideline on similar biological medicinal products containing biotechnology-derived proteins as active substance: Non-clinical and clinical issues. Guidance on similar medicinal products containing somatropin (http://www.emea.europa.eu/pdfs/human/biosimilar/9452805en.pdf)
9. European Medicines Agency (2006) Annex to guideline on similar biological medicinal products containing biotechnology-derived proteins as active substance: Non-clinical and clinical issues. Guidance on similar medicinal products containing recombinant human insulin (http://www.emea.europa.eu/pdfs/human/biosimilar/3277505en.pdf)
10. European Medicines Agency (2006) Annex to guideline on similar biological medicinal products containing biotechnology-derived proteins as active substance: Non-clinical and clinical issues. Guidance on similar medicinal products containing recombinant granulocyte-colony stimulating factor (G-CSF) (http://www.emea.europa.eu/pdfs/human/biosimilar/3132905en.pdf)
11. European Medicines Agency (2007) Guideline on immunogenicity assessment of biotechnology-derived therapeutic proteins (http://www.emea.europa.eu/pdfs/human/biosimilar/1432706enfin.pdf)
12. Casadevall N., Eckardt K.U., and Rossert J. Epoetin-induced autoimmune pure red cell aplasia. J. Am. Soc. Nephrol. 16 Suppl. 1 (2005) S67-S69
13. Schellekens H. Immunologic mechanisms of EPO-associated pure red cell aplasia. Best Pract. Res. Clin. Haematol. 18 (2005) 473-480
14. Schellekens H. Factors influencing the immunogenicity of therapeutic proteins. Nephrol. Dial. Transplant. 20 (2005) vi3-vi9
15. Abseamed Summary of product characteristics (http://www.emea.europa.eu/humandocs/PDFs/EPAR/abseamed/H-727-PI-en.pdf)
16. Binocrit Summary of product characteristics (http://www.emea.europa.eu/humandocs/PDFs/EPAR/binocrit/H-725-PI-en.pdf)
17. Epoetin alfa Hexal Summary of product characteristics (http://www.emea.europa.eu/humandocs/PDFs/EPAR/epoetinalfahexal/H-726-PI-en.pdf)
18. Silapo Summary of product characteristics (http://www.emea.europa.eu/humandocs/PDFs/EPAR/silapo/H-760-PI-en.pdf)
19. Retacrit Summary of product characteristics (http://www.emea.europa.eu/humandocs/PDFs/EPAR/retacrit/H-872-en6.pdf)
20. European Medicines Agency (2007) Retacrit: scientific discussion (http://www.emea.europa.eu/humandocs/PDFs/EPAR/retacrit/H-872-en6.pdf)
21. Hospira data on file
22. Schellekens H. The first biosimilar epoetin: but how similar is it?. Clin. J. Am. Soc. Nephrol. 3 (2008) 174-178