Biosimilars: Pharmacovigilance and risk management

Pharmacoepidemiology and Drug Safety

Volumn 19, Issue 7, 2010, Pages 661-669

  Zuñiga, Leyre ^a   Calvo, Begoña ^a  

^a UNIVERSITY OF THE BASQUE COUNTRY UPV EHU   (Spain)

Author keywords

Biosimilars; Follow on biologics; Immunogenicity; Pharmacovigilance; Risk management plan

Indexed keywords

ALPHA INTERFERON; GRANULOCYTE COLONY STIMULATING FACTOR; HUMAN GROWTH HORMONE; INSULIN; LOW MOLECULAR WEIGHT HEPARIN; RECOMBINANT ERYTHROPOIETIN; BIOLOGICAL PRODUCT;

ANAPHYLAXIS; DRUG MANUFACTURE; DRUG SAFETY; HEPARIN INDUCED THROMBOCYTOPENIA; HUMAN; HYPERTENSION; IMMUNOGENICITY; PHARMACEUTICS; POSTMARKETING SURVEILLANCE; PRIORITY JOURNAL; PURE RED CELL ANEMIA; REVIEW; RISK MANAGEMENT; THROMBOEMBOLISM; DRUG APPROVAL; DRUG SURVEILLANCE PROGRAM; EUROPEAN UNION; IMMUNOLOGY; PROCEDURES; THERAPEUTIC EQUIVALENCE;

ADVERSE DRUG REACTION REPORTING SYSTEMS; BIOLOGICAL PRODUCTS; DRUG APPROVAL; EUROPEAN UNION; HUMANS; RISK MANAGEMENT; THERAPEUTIC EQUIVALENCY;

EID: 77955636779     PISSN: 10538569     EISSN: 10991557     Source Type: Journal    
DOI: 10.1002/pds.1948     Document Type: Review

References (39)

1. International Conference of Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use. ICH E2E: Pharmacovigilance Planning. 2004; http://www.ich.org [accessed 1 December 2009].
2. Fruijtier A. Pharmaceutical postmarketing and compliance with the marketing authorisation. In Fundamentals of EU Regulatory Affairs Michor S, Rowl K (eds). RAPS Regulatory Affairs Professionals Society: Rockville (MA), 2006; 137-144.
3. EMEA/CHMP/BMWP/42832/05. Committee for medicinal products for human use. Guideline on Similar Biological Medicinal Products containing Biotechnology-Derived Proteins as Active Substance: Non-Clinical and Clinical Issues. 2006; http://www.emea.europa.eu [accessed 1 December 2009].
4. CHMP/437/04. Committee for medicinal products for human use. Guideline on Similar Biological Medicinal Products. 2005; http://www.emea.europa.eu [accessed 1 December 2009].
5. Nowicki M. Basic facts about biosimilars. Kidney Blood Press Res 2007; 30: 267-272.
6. Roger SD, Mikhail A. Biosimilars: opportunity or cause for concern? J Pharm Pharmaceut Sci 2007; 10: 405-410.
7. Porter S. Human immune response to recombinant human proteins. J Pharm Sci 2001; 90: 1-11.
8. CHMP/BMWP/14327/06. Committee for medicinal products for human use. Guideline on Immunogenicity Assessment of Biotechnology-derived Therapeutic Protein. 2008; http://www.emea.europa.eu [accessed 1 December 2009].
9. London G. Législation européenne sur le développement des biosimilaires: les recommandations de l'EMEA concernant l'efficacité et la sécurité. Nephrol & Therap 2009; 5: 6-9.
10. Bennett CL, Luminari S, Nissenson AR, et al. Pure red-cell aplasia and epoetin therapy. N Eng J Med 2004; 351: 1403-1408.
11. Schellekens H, Jiskoot W. Eprex-associated pure red cell aplasia and leachates. Nat Biotechnol 2006; 24: 613-614.
12. EudraLex [Homepage]. Volume 9A Guidelines on Pharmacovigilance for Medicinal Products for Human Use. In: The rules governing medicinal products in the European Union. 2007; http://ec.europa.eu [accessed 1 December 2009].
13. EMEA/192632/06 European Medicines Agency. Template for EU Risk Management Plan (EU-RMP). 2006; http://www.emea.europa.eu [accessed 1 December 2009].
14. Kramer I. Pharmacy and pharmacology of biosimilars. J Endocrinol Invest 2008; 31: 479-488.
15. Europa Bio Fact sheet. EupopaBIO & Biosimilar Medicines. 2008; http://www.europabio.org/positions/Healthcare/biosimilar-factsheet-December- 2008.pdf [accessed 1 December 2009].
16. European Commission proposals to revise EudraLex Volume 9A. http://ec.europa.eu/enterprise/pharmaceuticals/pharmacos/docs/doc2008/2008-03/ pc-vol9-03-2008.pdf [accessed 1 December 2009].
17. European Commission - Enterprise and Industry Directorate General "Strategy to better protect public health by strengthening and rationalising EU pharmacovigilance: public consultation on legislative proposals". 2007; http://ec.europa.eu/enterprise/pharmaceuticals/ pharmacovigilance/docs/public-consultation-12-2007.pdf [accessed 1 December 2009].
18. EMEA/CHMP/96268/2005. Guideline on Risk Management Systems for Medicinal Products for Human Use. 2005; http://www.emea.europa.eu [accessed 1 December 2009].
19. EMEA/CHMP/ICH/309348/2008. Committee for medicinal products for human use Note for guidance on Development Safety Update Report (ICH Topic E2F). 2008; http://www.emea.europa.eu [accessed 1 December 2009].
20. Directive 2004/27/EC of the European parliament and of the Council of 31 March 2004 amending Directive 2001/83/EC on the Community code relating to medicinal products for human use. 2004; http://ec.europa.eu [accessed 1 December 2009].
21. Regulation (EC) No 726/2004 of the European parliament and of the Council of 31 March 2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency. 2004; http://ec.europa.eu [accessed 1 December 2009].
22. Commission Regulation (EC) No 540/95 of 10 March 1995 laying down the arrangements for reporting suspected unexpected adverse reactions which are not serious, whether arising in the Community or in a third country, to medicinal products for human or veterinary use authorized in accordance with the provisions of Council Regulation (EEC) No 2309/93. 1995; http://ec.europa.eu [accessed 1 December 2009].
23. Kresse G. Biosimilars. Science, status, and strategic perspective. Eur J Pharm Biopharm 2009; 72: 479-486.
24. EMEA/CHMP/BMWP/301636/2008. Guideline on non-clinical and clinical development of similar biological medicinal products containing recombinant erythropoietins (Revision). 2009; http://www.emea.europa.eu [accessed 1 December 2009].
25. EMEA/CHMP/BMWP/31329/2005. 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 granulocytecolony stimulating factor. 2006; http://www.emea.europa.eu [accessed 1 December 2009].
26. EMEA/CHMP/BMWP/118264/2007. Guideline on non-clinical and clinical development of similar biological medicinal products containing low-molecular-weight-heparins. 2009; http://www.emea.europa.eu [accessed 1 December 2009].
27. EMEA/CHMP/BMWP/94528/2005. 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. 2006; http://www.emea.europa.eu [accessed 1 December 2009].
28. EMEA/CHMP/BMWP/102046/2006. Non-clinical and clinical development of similar medicinal products containing recombinant interferon alfa. 2009; http://www.emea.europa.eu [accessed 1 December 2009].
29. EMEA/CHMP/BMWP/32775/2005. 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 soluble insulin. 2006; http://www.emea.europa.eu [accessed 1 December 2009].
30. EMEA/CHMP/437/04. Guideline on similar biological medicinal products. 2005; http://www.emea.europa.eu/pdfs/human/biosimilar/043704.en.pdf [accessed 1 December 2009)].
31. Zuñiga L, Calvo B. Regulatory aspects of biosimilars in Europe. Trends Biotechnol 2009; 27: 385-387.
32. FDA's information page about Omnitrope. http://www.accessdata.fda.gov/ scripts/cder/drugsatfda/index.cfm?fuseaction=Search.DrugDetails [accessed 1 December 2009].
33. Woodcock J, Griffin J, Behrman R, et al. The FDA's assessment of follow-on protein products: a historical perspective. Nat Rev Drug Discov 2007; 6: 437-442.
34. Grawbowski H. Follow-on biologics: data exclusivity and the balance between innovation an competition. Nat Rev Drug Discov 2008; 7: 479-488.
35. Kawanishi T. Regulatory perspective from Japan - comparability of biopharmaceuticals. Biologicals 2006; 34(1): 65-68.
36. Horikawa H, Tsubouchi M, Kawakami K. Industry views of biosimilar development in Japan. Health Policy 2009; 91: 189-194.
37. Joung J, Rovertson JS, Griffiths E, et al. WHO informal consultation on regulatory evaluation of therapeutic biological medical products held at WHO Headquarters. Geneva, 19-20 April 2007 Biologicals 2008; 36: 269-276.
38. EMEA/74562/2006 Rev. 1 Questions and Answers on biosimilar medicines (similar biological medicinal products) 2008; http://www.emea.europa.eu [accessed 1 December 2009].
39. Schellekens H. Bioequivalence and the immunogenicity of biopharmaceuticals. Nat Rev Drug Discov 2002; 1: 457-462.