Interchangeability, immunogenicity and biosimilars

Nature Biotechnology

Volumn 30, Issue 12, 2012, Pages 1186-1190

  Ebbers, Hans C ^a   Crow, Stacy A ^b   Vulto, Arnold G ^b   Schellekens, Huub ^c  

^a UTRECHT UNIVERSITY   (Netherlands)

^b ERASMUS MEDICAL CENTER   (Netherlands)

^c UTRECHT UNIVERSITY   (Netherlands)

Author keywords

[No Author keywords available]

Indexed keywords

BIOSIMILAR AGENT; GLYCERYL TRINITRATE; HEXAL; HUMAN GROWTH HORMONE; RECOMBINANT ERYTHROPOIETIN; RECOMBINANT GRANULOCYTE COLONY STIMULATING FACTOR; SB 309; UNCLASSIFIED DRUG;

ANEMIA; DRUG APPROVAL; DRUG EFFICACY; DRUG FORMULATION; DRUG MARKETING; DRUG SAFETY; DRUG SURVEILLANCE PROGRAM; HUMAN; IMMUNOGENICITY; NEUTROPENIA; NONHUMAN; NOTE; PRIORITY JOURNAL; PRODUCT DEVELOPMENT; PRODUCT SAFETY; RENAL ANEMIA; RISK MANAGEMENT;

BIOSIMILAR PHARMACEUTICALS; BIOTECHNOLOGY; DRUG APPROVAL; EUROPEAN UNION; HUMANS; RISK MANAGEMENT; THERAPEUTIC EQUIVALENCY;

EID: 84870933584     PISSN: 10870156     EISSN: 15461696     Source Type: Journal    
DOI: 10.1038/nbt.2438     Document Type: Note

References (34)

1. European Commission. Off. J. Eur. Union L136, 34-57 (2004).
2. Health, I.M.S. Shaping the Biosimilars Opportunity: a Global Perspective on the Evolving Biosimilars Landscape (IMS Health, New York, USA, 2011; accessed 11 April 2012).
3. European Medicines Agency. Volume 9 A of The Rules Governing Medicinal Products in the European Union. (EMA, London, 2008; accessed 2 August 2012).
4. European Commission. Off. J. Eur. Union L311, 67-267 (2001).
5. European Medicines Agency. Guideline on Immunogenicity Assessment of Biotechnology-Derived Therapeutic Proteins (EMA, London, 2007; accessed 3 July 2012).
6. Casadevall, N. et al. N. Engl. J. Med. 346, 469-475 (2002).
7. Gascon, P. et al. Ann. Oncol. 21, 1419-1429 (2010).
8. European Medicines Agency. EPARs for Authorised Medicinal Products for Human Use (EMA, London; accessed 9 September 2012). http://www.ema.europa.eu/ ema/index.jsp?curl=pages/medicines/landing/epar-search.jsp&mid= WC0b01ac058001d124
9. Frau, S., Font Pous, M., Luppino, M.R. & Conforti, A. Eur. J. Clin. Pharmacol. 66, 785-790 (2010).
10. Haag-Weber, M. et al. Clin. Nephrol. 77, 8-17 (2012).
11. Seidl, A. et al. Pharm. Res. 29, 1454-1467 (2012).
12. Jiang, Y. et al. J. Pharm. Sci. 98, 4695-4710 (2009).
13. Praditpornsilpa, K. et al. Kidney Int. 80, 88-92 (2011).
14. Peterson, G.M. Br. J. Clin. Pharmacol. 71, 966-967, author reply 968 (2011).
15. Meredith, P.A. Curr. Med. Res. Opin. 25, 2179-2189 (2009).
16. Walsh, G. Drug Discov. Today 15, 773-780 (2010).
17. European Medicines Agency. Guideline on Similar Biological Medicinal Products Containing Biotechnology-Derived Proteins as Active Substance: Non-Clinical and Clinical Issues EMEA/CHMP/BMWP/42832/2005 (EMA, London, 2006; accessed 26 July 2012).
18. European Medicines Agency. Guideline on Similar Biological Medicinal Products Containing Biotechnology-Derived Proteins as Active Substance: Quality Issues (EMA, London, 2006). http://www.ema.europa.eu/docs/en-GB/document- library/Scientific-guideline/2009/09/WC500003953.pdf
19. Covic, A. et al. Nephrol. Dial. Transplant. 23, 3731-3737 (2008).
20. Rovira, J., Espin, J., Garcia, L. & Olry de Labry, A. The Impact of Biosimilars' Entry in the EU Market (Andalusian School of Public Health, Spain, 2011).
21. Niederwieser, D. & Schmitz, S. Eur. J. Haematol. 86, 277-288 (2011).
22. Minghetti, P., Rocco, P., Del Vecchio, L. & Locatelli, F. Nephron Clin. Pract. 117, c1-c7 (2011).
23. Brinks, V. et al. Pharm. Res. 28, 386-393 (2011).
24. Storring, P.L. et al. Br. J. Haematol. 100, 79-89 (1998).
25. Schiestl, M. et al. Nat. Biotechnol. 29, 310-312 (2011).
26. Vanrenterghem, Y. et al. Kidney Int. 62, 2167-2175 (2002).
27. Dellanna, F. et al. Int. J. Clin. Pract. 65, 64-72 (2011).
28. Ebbers, H.C., Muenzberg, M. & Schellekens, H. Exp. Opin. Biol. Ther. 12, 1473-1485 (2012).
29. Duerden, M.G. & Hughes, D.A. Br. J. Clin. Pharmacol. 70, 335-341 (2010).
30. Kresse, G.B. Eur. J. Pharm. Biopharm. 72, 479-486 (2009).
31. Declerck, P.J. et al. Curr. Med. Res. Opin. 26, 1219-1229 (2010).
32. Shankar, G., Pendley, C. & Stein, K.E. Nat. Biotechnol. 25, 555-561 (2007).
33. Macdougall, I.C. et al. N. Engl. J. Med. 361, 1848-1855 (2009).
34. European Medicines Agency. Scientific Guidance Documents on Biosimilar Medicines (EMA, London; accessed 4 September 2012)