Medication practice in hospitals: Are nanosimilars evaluated and substituted correctly?

European Journal of Hospital Pharmacy

Volumn 25, Issue 2, 2018, Pages 79-84

  Knoeff, Josefien ^a,b   Flühmann, Beat ^a   Mühlebach, Stefan ^a,c  

^a Vifor (International) Inc   (Switzerland)

^b VU UNIVERSITY AMSTERDAM   (Netherlands)

^c UNIVERSITY OF BASEL   (Switzerland)

Author keywords

drug interchange; intravenous iron; non biological complex drugs

Indexed keywords

IRON SACCHARATE;

ARTICLE; CLINICAL DECISION MAKING; DRUG COST; DRUG EFFICACY; DRUG SAFETY; FRANCE; HUMAN; MEDICAL PRACTICE; PHARMACIST; QUESTIONNAIRE; SPAIN;

EID: 85040752970     PISSN: 20479956     EISSN: 20479964     Source Type: Journal    
DOI: 10.1136/ejhpharm-2016-001059     Document Type: Article

References (24)

1. Crommelin DJA, de Vlieger JSB, Weinstein V, et al. Different pharmaceutical products need similar terminology. AAPS J 2014;16:11-14.
2. Rottembourg JB, Kadri A, Leonard E, et al. Do two intravenous iron sucrose preparations have the same efficacy? Nephrol Dial Transplant 2011;26:3262-7.
3. Agüera ML, Martin-Malo A, Alvarez-Lara MA, et al. Efficiency of original versus generic intravenous iron formulations in patients on haemodialysis. PLoS ONE 2015;10:e0135967.
4. Barot BS, Parejiya PB, Mehta DM, et al. Physicochemical and structural characterization of iron-sucrose formulations: a comparative study. Pharm Dev Technol 2014;19:513-20.
5. Toblli JE, Cao G, Oliveri L, et al. Comparison of oxidative stress and inflammation induced by different intravenous iron sucrose similar preparations in a rat model. Inflamm Allergy Drug Targets 2012;11:66-78.
6. Toblli JE, Cao G, Angerosa M. Nitrosative stress and apoptosis in non-anemic healthy rats induced by intravenous iron sucrose similars versus iron sucrose originator. BioMetals 2015;28:279-92.
7. Toblli JE, Cao G, Oliveri L, et al. Differences between the original iron sucrose complex Venofer® and the iron sucrose similar Generis®, and potential implications. Port J Nephrol Hypert 2009;23:53-63.
8. Meier T, Schropp P, Pater C, et al. Physicochemical and toxicological characterization of a new generic iron sucrose preparation. Arzneimittelforschung 2011;61:112-19.
9. Martin-Malo A, Merino A, Carracedo J, et al. Effects of intravenous iron on mononuclear cells during the haemodialysis session. Nephrol Dial Transplant 2012;27:2465-71.
10. Lee ES, Park BR, Kim JS, et al. Comparison of adverse event profile of intravenous iron sucrose and iron sucrose similar in postpartum and gynecologic operative patients. Curr Med Res Opin 2013;29:1-7.
11. European Medicines Agency (EMA). Reflection paper on the data requirements for intravenous iron-based nano-colloidal products developed with reference to an innovator medicinal product. 2015. http://www.ema.europa.eu/docs/en-GB/ document-library/Scientific-guideline/2015/03/WC500184922.pdf
12. European Medicines Agency (EMA). Reflection paper on non-clinical studies for generic nanoparticle iron medicinal product applications. 2011. http://www.ema. europa.eu/docs/en-GB/document-library/Scientific-guideline/2011/04/ WC500105048.pdf
13. European Medicines Agency (EMA). Reflection paper on the data requirements for intravenous liposomal products developed with reference to an innovator liposomal product. 2013. http://www.ema.europa.eu/docs/en-GB/document-library/Scientific- guideline/2013/03/WC500140351.pdf
14. European Medicines Agency (EMA). Joint MHLW/EMA reflection paper on the development of block copolymer micelle medicinal products Joint MHLW/EMA reflection paper on the development of block copolymer micelle medicinal products Table of contents. 2013. http://www.ema.europa.eu/docs/en-GB/document-library/ Scientific-guideline/2013/02/WC500138390.pdf
15. Bourdon O, Ekeland C, Brion F. Pharmacy education in France. Am J Pharm Educ 2008;72:132.
16. EAHP. Spanish Society of Hospital Pharmacists. 2016. http://www.eahp.eu/about-us/ members/spain
17. Bailie GR. Comparison of rates of reported adverse events associated with i.v. iron products in the United States. Am J Health Syst Pharm 2012;69:310-20.
18. Beguin Y, Jaspers A. Iron sucrose - characteristics, efficacy and regulatory aspects of an established treatment of iron deficiency and iron-deficiency anemia in a broad range of therapeutic areas. Expert Opin Pharmacother 2014;15:2087-103.
19. Chertow GM, Mason PD, Vaage-Nilsen O, et al. On the relative safety of parenteral iron formulations. Nephrol Dial Transplant 2004;19:1571-5.
20. Chertow GM, Mason PD, Vaage-Nilsen O, et al. Update on adverse drug events associated with parenteral iron. Nephrol Dial Transplant 2006;21:378-82.
21. Mühlebach S, Flühmann B. Iron carbohydrate complexes: characteristics and regulatory challenges. In: Non-biological complex drugs. Eds: Crommelin DJA, de Vlieger JSB. Springer International Publishing, 2015:149-70.
22. Griffith N, McBride A, Stevenson JG, et al. Formulary selection criteria for biosimilars: considerations for US health-system pharmacists. Hosp Pharm 2014;49:813-25.
23. Boone N, Kuy HVD, Scott M, et al. How to select a biosimilar. Eur J Hosp Pharm 2013;20:275-86.
24. Schellekens H, Klinger E, Mühlebach S, et al. The therapeutic equivalence of complex drugs. Regul Toxicol Pharmacol 2011;59:176-83.