Biosimilars: Uncharted territory

Journal of Nephrology

Volumn 20, Issue 3, 2007, Pages 265-267

  Locatelli, Francesco ^a   Goldsmith, David ^b  

^a A MANZONI HOSPITAL   (Italy)

^b GUY S HOSPITAL   (United Kingdom)

Author keywords

Biosimilar; EMEA; Epoetin; Erythropoietin stimulating agent; European Best Practice Guidelines

Indexed keywords

BIOLOGICAL PRODUCT; ERYTHROPOIETIN; GENERIC DRUG; GROWTH HORMONE; HEMOGLOBIN; RECOMBINANT ERYTHROPOIETIN;

ANEMIA; ARTICLE; CHRONIC KIDNEY DISEASE; CLINICAL PRACTICE; CLINICAL TRIAL; DRUG APPROVAL; DRUG EXPOSURE; DRUG INDUSTRY; DRUG MARKETING; DRUG SAFETY; DRUG SCREENING; DRUG SURVEILLANCE PROGRAM; DRUG WITHDRAWAL; EUROPE; FOOD AND DRUG ADMINISTRATION; HEALTH CARE ACCESS; HUMAN; MEDICAL DECISION MAKING; PATENT; POSTMARKETING SURVEILLANCE; PURE RED CELL ANEMIA;

BIOLOGICAL PRODUCTS; THERAPEUTIC EQUIVALENCY;

EID: 35348862458     PISSN: 11218428     EISSN: 17246059     Source Type: Journal    
DOI: None     Document Type: Article

References (10)

1. Committee for Medicinal Products for Human Use. Guidelines on similar biological medicinal products containing biotechnology-derived proteins as active substance: quality issues. London, 2006 [cited 2007 Mar 20]. Available from: http://www.emea.eu.int/.
2. Committee for Medicinal Products for Human Use. Guidelines on similar biological medicinal products containing biotechnology-derived proteins as active substance: non-clinical and clinical issues. London, 2006 [cited 2007 Mar 20]. Available from: http://www.emea.eu.int/.
3. Europa press release (online 2006 Apr 20): biotech medicines: first biosimilar drug on EU market [cited 2007 Mar 20]. Available from: http:// www.europa.eu.int/rapid/pressReleasesAction.do?reference=IP/06/ 511&format=HTML.
4. Sandoz Inc. press release (online 2006 May 31): Sandoz gets precedent-setting US approval for Omnitrope as first follow-on version of a previously approved recombinant biotechnology drug [cited 2007 Mar 20]. Available from: hftp://www.sandoz.com/site/en/company/media/news/ detail/news_310506.shtml.
5. Schellekens H. Immunologic mechanisms of EPO-associated pure red cell aplasia. Baillieres Best Pract Res Clin Haematol 2005; 18: 473-80.
6. Locatelli F, Aljama P, Barany P, Canaud B, Carrera F, Eckardt KU, Macdougall IC, Macleod A, Horl WH, Wiecek A, Cameron S. Erythropoiesis-stimulating agents and anti-body-mediated pure red-cell aplasia: here are we now and where do we go from here? Nephrol Dial Transplant 2004; 19: 288-93.
7. Locatelli F, Del Vecchio L. Pure red cell aplasia secondary to treatment with erythropoietin [review]. J Nephrol 2003; 16: 461-6.
8. Committee for Medicinal Products for Human Use. Annex to guideline on similar biological medicinal products containing biotechnology-derived proteins as active substance: non-clinical and clinical issues. Guidance in similar medicinal products containing recombinant erythropoietins. London, 2006 [cited 2007 Mar 20]. Available from: http://www.emea.eu.int/.
9. Goldsmith D. Commentary. Nephrol Dial Transplant 2006; 21: v1-v3.
10. Locatelli F, Roger S. Comparative testing and pharmacovigilance of biosimilars. Nephrol Dial Transplant 2006; 21 (Suppl 5): v13-6.