NDT Advance Access originally published online on September 18, 2008
Nephrology Dialysis Transplantation 2008 23(12):3731-3737; doi:10.1093/ndt/gfn519
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© The Author [2008]. Published by Oxford University Press on behalf of ERA-EDTA. All rights reserved. For Permissions, please e-mail: journals.permissions@oxfordjournals.org
Biosimilars and biopharmaceuticals: what the nephrologists need to know—a position paper by the ERA-EDTA Council
1 Dialysis and Transplantation Center, Dr. C.I. Parhon University Hospital, Iasi, Romania 2 Bone and Mineral Research Unit, Universidad de Oviedo, Hospital Universitario Central de Asturias, Oviedo, Spain 3 Nephrology Department, Nephrology Institute, Brescia 4 Nephrology and Dialysis Department, Regina Margherita Hospital, Torino, Italy 5 Hospital S. João, Serviço de Nefrologia, Al. Hernâni Monteiro, 4200 Porto, Portugal 6 Department of Nephrology, Guy's & St. Thomas' Hospital, London, UK 7 Nephrology Department and INSERM Unit 702, Tenon Hospital, Paris, France 8 Department of Nephrology, Clinical Center Skopje, University of Skopje, F.Y.R. Macedonia 9 Department of Clinical Science, Technology and Intervention, Karolinska Institutet, Stockholm, Sweden 10 Department of Nephrology, Erciyes University Medical Faculty, Kayseri, Turkey 11 Department of Nephrology, Silesian School of Medicine, Katowice, Poland 12 CNR, Renal, Hypertension and Transplantation Unit, Ospedali Riuniti, Reggio Calabria, Italy 13 Department of Nephrology, Centre Hospitalier, Mahnes, Fleury, France
Correspondence and offprint requests to: Adrian Covic, Dialysis and Transplantation Center, Dr. C.I. Parhon University Hospital, Carol 1st Blvd. Nr. 50, Iasi 700503, Romania. Tel: +40-721-280246; Fax: +40-232-211752; E-mail: acovic@xnet.ro
Keywords: biopharmaceuticals; biosimilars; ERA-EDTA position paper; pharmacovigilance
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Introduction |
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Since January 2008, four biosimilars have been approved by EMEA: two human growth hormone analogues and two erythropoiesis-simulating agents (ESAs) (in five different branding versions). The ESAs were approved despite some differences from the comparator product in potency and consistency. For example (as shown in the official EMEA document), epoetin zeta (SB309) ‘provided evidence that a difference of 35.3 IU/kg/week in epoetin dose (worst case scenario) was clinically not relevant in the investigated study population, whether this difference was calculated as absolute value or as percentage of the reference dose (21%)’ [1]. At the same time, a biosimilar interferon product was rejected because of concerns about stability, impurities, validation of the manufacturing process and differences in outcomes and adverse effects [2].
In response to a letter from European Biopharmaceutical Enterprises (EBE) and concerns from the renal community, the ERA-EDTA Council meeting decided in Porto, during the
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Definition, history and implications of biosimilars |
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Challenges in pharmaceutical manufacturing with biological drugs |
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Theoretical concerns with biosimilars |
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Glycosylation
Contamination
Changes to three-dimensional structure
Other causes
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EMEA guidelines |
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Pharmacodynamics studies
In vitro studies
In vivo animal studies
Toxicological studies
Clinical studies
Pharmacokinetic studies
Pharmacodynamic studies
Clinical efficacy studies
Clinical safety data
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Pharmacovigilance in the EU |
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Automatic substitution and INN |
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Conclusions |
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