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Hematology: Research Letter

Clinical case reports raise doubts about the therapeutic equivalence of an iron sucrose similar preparation compared with iron sucrose originator

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Pages 241-243 | Accepted 16 Dec 2011, Published online: 18 Jan 2012

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Read on this site (5)

Jorge E Toblli, Gabriel Cao, Luis Rico & Margarita Angerosa. (2017) Cardiovascular, liver, and renal toxicity associated with an intravenous ferric carboxymaltose similar versus the originator compound. Drug Design, Development and Therapy 11, pages 3401-3412.
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Jürgen Stein, Ayşegül Aksan, Karima Farrag, Axel Dignass & Heinfried H Radeke. (2017) Management of inflammatory bowel disease-related anemia and iron deficiency with specific reference to the role of intravenous iron in current practice. Expert Opinion on Pharmacotherapy 18:16, pages 1721-1737.
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Monika Praschberger, Carolin Cornelius, Markus Schitegg, Hans Goldenberg, Barbara Scheiber-Mojdehkar & Brigitte Sturm. (2015) Bioavailability and stability of intravenous iron sucrose originator versus generic iron sucrose AZAD. Pharmaceutical Development and Technology 20:2, pages 176-182.
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Eun Sil Lee, Bo Ra Park, Jeong Sig Kim, Gyu Yeon Choi, Jeong Jae Lee & Im Soon Lee. (2013) Comparison of adverse event profile of intravenous iron sucrose and iron sucrose similar in postpartum and gynecologic operative patients. Current Medical Research and Opinion 29:2, pages 141-147.
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Articles from other publishers (34)

Zhuo Sun, Ji Jiang & Xia Chen. (2020) Evaluation of Therapeutic Equivalence for the Follow-On Version of Intravenously Administered Non-Biological Complex Drugs. Clinical Pharmacokinetics 59:8, pages 995-1004.
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Iain C. Macdougall, Josep Comin-Colet, Christian Breymann, Donat R. Spahn & Ioannis E. Koutroubakis. (2020) Iron Sucrose: A Wealth of Experience in Treating Iron Deficiency. Advances in Therapy 37:5, pages 1960-2002.
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Benjamin Elstrott, Lubna Khan, Sven Olson, Vikram Raghunathan, Thomas DeLoughery & Joseph J. Shatzel. (2019) The role of iron repletion in adult iron deficiency anemia and other diseases. European Journal of Haematology 104:3, pages 153-161.
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Tiziana Di Francesco, Léadie Delafontaine, Erik Philipp, Elmira Lechat & Gerrit Borchard. (2020) Iron polymaltose complexes: Could we spot physicochemical differences in medicines sharing the same active pharmaceutical ingredient?. European Journal of Pharmaceutical Sciences 143, pages 105180.
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K. Klein, P. Stolk, M.L. De Bruin, H.G.M. Leufkens, D.J.A. Crommelin & J.S.B. De Vlieger. (2019) The EU regulatory landscape of non-biological complex drugs (NBCDs) follow-on products: Observations and recommendations. European Journal of Pharmaceutical Sciences 133, pages 228-235.
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Tiziana Di Francesco, Emmanuelle Sublet & Gerrit Borchard. (2019) Nanomedicines in clinical practice: Are colloidal iron sucrose ready-to-use intravenous solutions interchangeable?. European Journal of Pharmaceutical Sciences 131, pages 69-74.
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Alejandro Martin‐Malo, Gerrit Borchard, Beat Flühmann, Claudio Mori, Donald Silverberg & Ewa A. Jankowska. (2019) Differences between intravenous iron products: focus on treatment of iron deficiency in chronic heart failure patients. ESC Heart Failure 6:2, pages 241-253.
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M. Aapro, Y. Beguin, C. Bokemeyer, M. Dicato, P. Gascón, J. Glaspy, A. Hofmann, H. Link, T. Littlewood, H. Ludwig, A. Österborg, P. Pronzato, V. Santini, D. Schrijvers, R. Stauder, K. Jordan & J. Herrstedt. (2018) Management of anaemia and iron deficiency in patients with cancer: ESMO Clinical Practice Guidelines. Annals of Oncology 29, pages iv96-iv110.
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Sunil Bhandari, Dora Pereira, Helen Chappell & Hal Drakesmith. (2018) Intravenous Irons: From Basic Science to Clinical Practice. Pharmaceuticals 11:3, pages 82.
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Amy Barton Pai, Manjunath P. Pai, Dan E. Meyer, Brian C. Bales, Victoria E. Cotero, Nan Zheng & Wenlei Jiang. (2018) In vitro and in vivo DFO-chelatable labile iron release profiles among commercially available intravenous iron nanoparticle formulations. Regulatory Toxicology and Pharmacology 97, pages 17-23.
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Julia Schnorr, Sören Fütterer, Karsten Spicher, Maria Catarinolo, Christoph Schlösser, Harald Enzmann & Peter Langguth. (2018) Bioequivalence decision for nanoparticular iron complex drugs for parenteral administration based on their disposition. Regulatory Toxicology and Pharmacology 94, pages 293-298.
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Tiziana Di Francesco & Gerrit Borchard. (2018) A robust and easily reproducible protocol for the determination of size and size distribution of iron sucrose using dynamic light scattering. Journal of Pharmaceutical and Biomedical Analysis 152, pages 89-93.
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Jacques Rottembourg & Guy Rostoker. (2018) L’utilisation de génériques en transplantation : vers des solutions rationnelles et sures !. La Presse Médicale 47:3, pages 199-210.
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Dajun Sun, Rodney Rouse, Vikram Patel, Yong Wu, Jiwen Zheng, Alokita Karmakar, Anil Patri, Priyanka Chitranshi, David Keire, Jia Ma & Wenlei Jiang. (2018) Comparative Evaluation of U.S. Brand and Generic Intravenous Sodium Ferric Gluconate Complex in Sucrose Injection: Physicochemical Characterization. Nanomaterials 8:1, pages 25.
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Tiziana Di Francesco, Erik Philipp & Gerrit Borchard. (2017) Iron sucrose: assessing the similarity between the originator drug and its intended copies. Annals of the New York Academy of Sciences 1407:1, pages 63-74.
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Amy Barton Pai. (2017) Complexity of intravenous iron nanoparticle formulations: implications for bioequivalence evaluation. Annals of the New York Academy of Sciences 1407:1, pages 17-25.
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Alain Astier, Amy Barton Pai, Marco Bissig, Daan J.A. Crommelin, Beat Flühmann, Jean-Daniel Hecq, Josefien Knoeff, Hans-Peter Lipp, Alberto Morell-Baladrón & Stefan Mühlebach. (2017) How to select a nanosimilar. Annals of the New York Academy of Sciences 1407:1, pages 50-62.
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Peng Zou, Katherine Tyner, Andre Raw & Sau Lee. (2017) Physicochemical Characterization of Iron Carbohydrate Colloid Drug Products. The AAPS Journal 19:5, pages 1359-1376.
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Nan Zheng, Dajun D. Sun, Peng Zou & Wenlei Jiang. (2017) Scientific and Regulatory Considerations for Generic Complex Drug Products Containing Nanomaterials. The AAPS Journal 19:3, pages 619-631.
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AB Pai, DE Meyer, BC Bales, VE Cotero, MP Pai, N Zheng & W Jiang. (2017) Performance of Redox Active and Chelatable Iron Assays to Determine Labile Iron Release From Intravenous Iron Formulations. Clinical and Translational Science 10:3, pages 194-200.
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Jacques Rottembourg & Guy Rostoker. (2015) Utilisation des dérivés injectables du fer au cours de la maladie rénale chronique : intérêts, limites et conseils pour un bon usage. Néphrologie & Thérapeutique 11:7, pages 531-542.
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Gian Carlo Di Renzo, Filippo Spano, Irene Giardina, Eleonora Brillo, Graziano Clerici & Luis Cabero Roura. (2015) Iron Deficiency Anemia in Pregnancy. Women's Health 11:6, pages 891-900.
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Karsten Spicher, Susanne Brendler-Schwaab, Christoph Schlösser, Maria Catarinolo, Sören Fütterer, Peter Langguth & Harald Enzmann. (2015) Differences in tissue distribution of iron from various clinically used intravenous iron complexes in fetal avian heart and liver.. Regulatory Toxicology and Pharmacology 73:1, pages 65-72.
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Daan J.A. Crommelin, Vinod P. Shah, Imre Klebovich, Scott E. McNeil, Vera Weinstein, Beat Flühmann, Stefan Mühlebach & Jon S.B. de Vlieger. (2015) The similarity question for biologicals and non-biological complex drugs. European Journal of Pharmaceutical Sciences 76, pages 10-17.
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Jorge E. Toblli, Gabriel Cao & Margarita Angerosa. (2015) Nitrosative stress and apoptosis in non-anemic healthy rats induced by intravenous iron sucrose similars versus iron sucrose originator. BioMetals 28:2, pages 279-292.
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Stefan Mühlebach & Beat Flühmann. 2015. Non-Biological Complex Drugs. Non-Biological Complex Drugs 149 170 .
Huub Schellekens, Sven Stegemann, Vera Weinstein, Jon S. B. de Vlieger, Beat Flühmann, Stefan Mühlebach, Rogério Gaspar, Vinod P. Shah & Daan J. A. Crommelin. (2013) How to Regulate Nonbiological Complex Drugs (NBCD) and Their Follow-on Versions: Points to Consider. The AAPS Journal 16:1, pages 15-21.
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S. Fütterer, I. Andrusenko, U. Kolb, W. Hofmeister & P. Langguth. (2013) Structural characterization of iron oxide/hydroxide nanoparticles in nine different parenteral drugs for the treatment of iron deficiency anaemia by electron diffraction (ED) and X-ray powder diffraction (XRPD). Journal of Pharmaceutical and Biomedical Analysis 86, pages 151-160.
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Taija S. Koskenkorva-Frank, Günter Weiss, Willem H. Koppenol & Susanna Burckhardt. (2013) The complex interplay of iron metabolism, reactive oxygen species, and reactive nitrogen species: Insights into the potential of various iron therapies to induce oxidative and nitrosative stress. Free Radical Biology and Medicine 65, pages 1174-1194.
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Vinod P. Shah, Arnold G. Vulto & Stefan Mühlebach. (2013) Workshop on the challenges in substitution of nonbiological complex drugs. American Journal of Health-System Pharmacy 70:21, pages 1879-1880.
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Fernando Gomollón & Javier P. Gisbert. (2013) Current Management of Iron Deficiency Anemia in Inflammatory Bowel Diseases: A Practical Guide. Drugs 73:16, pages 1761-1770.
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Xinyuan Zhang, Nan Zheng, Robert A Lionberger & Lawrence X Yu. (2013) Innovative approaches for demonstration of bioequivalence: the US FDA perspective. Therapeutic Delivery 4:6, pages 725-740.
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Fernando Gomollón & Javier P. Gisbert. (2013) Intravenous iron in inflammatory bowel diseases. Current Opinion in Gastroenterology 29:2, pages 201-207.
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Gerrit Borchard, Beat Flühmann & Stefan Mühlebach. (2012) Nanoparticle iron medicinal products – Requirements for approval of intended copies of non-biological complex drugs (NBCD) and the importance of clinical comparative studies. Regulatory Toxicology and Pharmacology 64:2, pages 324-328.
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