This page contains a Flash digital edition of a book.
Introduction


liposomes. Non-equivalence of NBCD follow-on versions, authorised by the classical generic paradigm, which is not valid for these highly complex synthetic nanoparticle drugs, has triggered these considerations.3


Therefore a similar


instead of a sameness approach is necessary,12


and a defined and accepted


nomenclature is lacking but is mandatory for harmonised regulations. Whereas for nanomedicines a defined similar approach is almost lacking, support and experience from the biosimilar approach could be used to progress, although these nanosimilars are synthetic and therefore not biological. l


References 1. Schellekens H et al. The therapeutic equivalence of complex drugs. Regul Toxicol Pharmacol 2011;59:176–83.


2. Flühman B et al. The authorization of non-biological complex drug (NBCDs) follow-on versions: specific regulatory and interchangeability rules ahead? GaBI J 2013;2:204–17.


3. Schellekens H et al. How to regulate nonbiological complex drugs (NBCD) and their follow-on versions: Points to consider. AAPS J 2014;16:15–21.


4. Tinkle S et al. Nanomedicines: addressing the scientific and regulatory gap. Ann NY Acad Sci 2014;1313:35–56.


5. Mühlebach S, Borchard G, Yildiz. Regulatory challenges and approaches to characterize nanomedicines and their follow-on similars. Nanomedicine 2015;10:659–74.


6. Borchard G. Complex molecules – current developments. GaBi J 2014;3:54–5.


7. Crommelin DJA et al. Different pharmaceutical products need similar terminology. AAPS J 2014;16:11–14.


8. Mühlebach S, Flühmann B, Walson PD. First Asia-Pacific educational workshop on non-biological complex drugs (NBCDs). Kuala Lumpur, Malaysia. GaBi J 2014;3:30–3.


9. Meredith PA. Generic drugs. Therapeutic equivalence. Drug Saf 1996;15:233–42.


10. Chen ML et al. Bioavailability and bioequivalence: an FDA regulatory overview. Pharm Res 2001;18:1645–50.


11. Al-Jazaira AS et al. Brand and generic medications: are they interchangeable? Ann Saudi Med 2008;28:33–41.


12. Borchard G, Flühmann B, Muhlebach S. Nanoparticle iron medicinal products- requirements for approval of intended copies of non-biological complex drugs (NBCD) and the importance of clinical comparative studies. Regul Toxicol Pharmacol 2012;64:324–8.


6 13. Crommelin DJA et al. The similarity question for www.hospitalpharmacyeurope.com


biological and non-biological complex drugs. Eur J Pharm Sci 2015;76:10–17.


14. Rottembourg J et al. Do two intravenous iron sucrose preparations have the same efficacy? Nephrol Dial Transplant 2011;26:3262–7.


15. Martin-Malo A et al. Effects of intravenous iron on mononuclear cells during haemodialysis session. Nephrol Dial Transplant 2012;27: 2465–71.


16. Stein J, Chow AK. Clinical case reports raise doubts about the therapeutic equivalence of an iron sucrose similar preparation compared with iron sucrose originator. Curr Med Res Opin 2012;28:241–3.


17. Lee ES 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;29:141–7.


18. Rostoker G et al. Hemodialysis-associated hemosiderosis in the era of erythropoiesis- stimulating agents: an MRI study. Am J Med 2012;125:991–9.


19. European Medicines Agency. Committee for Human Medicinal Products (CHMP). Reflection paper on non-clinical studies for generic nanoparticle iron medicinal product applications 2011. www.ema.europa.eu/ema/ pages/includes/document/open_document. jsp?webContentld=WC500105048 (accessed January 2016).


20. US Food and Drug Adminstration., Draft guidance on iron sucrose. www.fda.gov/ downloads/drugs/


guidancecomplianceregulatoryinformation/ guidances/ucm297630.pdf (accessed January 2016).


21. US Food and Drug Administration. Solicitation on the therapeutic equivalence of generic iron complex product. https://fbo.gov/index?s=opp ortunity&mode=form&id=592788989854da145 c8e7b6d103c898d&tab=core&tabmode=list& (accessed January 2016).


22. Chang HI, Yeh MK. Clinical development of


liposome-based drugs: formulation, characterization, and therapeutic efficacy. Int J Nanomed 2012;7:49–60.


23. Mamidi RNVS et al. Pharmacokinetics, efficacy and toxicity of different pegylated liposomal doxorubicin formulations in preclinical models: is a conventional bioequivalence approach sufficient to ensure therapeutic equivalence of pegylated liposomal doxorubicin products? Cancer Chemother Pharmacol 2010;66:1173–84. – the first FDA-approved


24. Barenholz Y. Doxil®


nano-drug: lessons learned. J Control Release 2012;160:117–34.


25. US Food and Drug Administration. Draft guidance on doxorubicin hydrochloride, February 2010, www.fda.gov/downloads/ Drugs/…/Guidances/ UCM199635.pdf (accessed January 2016).


26. Varkony H et al. The glatiramoid class of immune-modulator drugs. Expert Opin Pharmacother 2009;10:657–68.


27. Citizen Petition submitted by Teva to the FDA, June 4, 2012. www.regulations.gov/contentStre amer?objectId=0900006481031791&disposition =attachment&contentType=pdf.


28. Ehmann F et al. Next-generation nanomedicines and nanosimilars: EU regulators’ initiatives relating to the development and evaluation of nanomedicines. Nanomedicine 2013;8:849–56.


29. Vial J et al. Pharmaceutical quality of docetaxel generics versus originator drug product a comparative analysis. Curr Med Res Opin 2008;24:2019–33.


30. Dawidczyk CM et al. State-of-the-art in design rules for drug delivery platforms: lessons from FDA-approved nanomedicines. J Control Release 2014;187:133–44.


31. European Medicines Agency. European public assessment reports. www.ema.europa.eu.


32. US Food and Drug Administration. Guidance for industry scientific considerations in demonstrating biosimilarity to a reference product. www.fda.gov.


Page 1  |  Page 2  |  Page 3  |  Page 4  |  Page 5  |  Page 6  |  Page 7  |  Page 8  |  Page 9  |  Page 10  |  Page 11  |  Page 12  |  Page 13  |  Page 14  |  Page 15  |  Page 16  |  Page 17  |  Page 18  |  Page 19  |  Page 20  |  Page 21  |  Page 22  |  Page 23  |  Page 24