Workshop on the challenges in substitution of nonbiological complex drugs
Author:
Affiliation:
1. North Potomac, MD
2. Hospital Pharmacy Erasmus University Medical Center Rotterdam, Netherlands
3. Vifor Pharma Ltd. Flughofstrasse 61 P.O. Box CH-8152 Glattbrugg, Switzerland
Publisher
Oxford University Press (OUP)
Subject
Health Policy,Pharmacology
Link
http://academic.oup.com/ajhp/article-pdf/70/21/1879/28364696/ajhp1879.pdf
Reference8 articles.
1. The therapeutic equivalence of complex drugs;Schellekens;Regul Toxicol Pharmacol.,2011
2. Nanoparticle iron medicinal products—requirements for approval of intended copies of nonbiological complex drugs (NBCD) and the importance of clinical comparative studies;Borchard;Regul Toxicol Pharmacol.,2012
3. Do two intravenous iron sucrose preparations have the same efficacy?;Rottembourg;Nephrol Dial Transplant.,2011
4. Comparison of adverse event profile of intravenous iron sucrose and iron sucrose similar in postpartum and gynecologic operative patients;Lee;Curr Med Res Opin.,2013
5. Clinical case reports raise doubts about the therapeutic equivalence of an iron sucrose similar preparation compared with iron sucrose originator;Stein;Curr Med Res Opin.,2012
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1. Tackling the challenges of nanomedicines: are we ready?;American Journal of Health-System Pharmacy;2021-02-18
2. Regulatory challenges and approaches to characterize nanomedicines and their follow-on similars;Nanomedicine;2015-03
3. Iron Carbohydrate Complexes: Characteristics and Regulatory Challenges;Non-Biological Complex Drugs;2015
4. Clinical development, immunogenicity, and interchangeability of follow-on complex drugs;Generics and Biosimilars Initiative Journal;2014-06-15
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