Literature DB >> 23052412

A population-based study comparing biosimilar versus originator erythropoiesis-stimulating agent consumption in 6,117 patients with renal anaemia.

Franziska Hörbrand1, Peter Bramlage, Johann Fischaleck, Joerg Hasford, Reinhard Brunkhorst.   

Abstract

AIMS: There are concerns that biosimilar erythropoiesis-stimulating agents (ESAs) are less effective than the originator ESAs. The objective of our study was to investigate differences between originator and biosimilar ESA utilisation based on defined daily doses (DDD), doses upon switching, differences between short- and long-acting ESAs and prescribed daily doses (PDD) of either ESA in ambulatory patients with renal anaemia undergoing chronic maintenance haemodialysis [chronic kidney disease (CKD) stage 5].
METHODS: Patients with CKD stage 5 and specific pharmacotherapy with ESAs for at least six 3-month periods (accounting quarters) were selected from a population-based database of accounting information of Bavarian physicians and pharmacy claims data (January 2008 to December 2010). The DDD was used to determine mean ESA consumption. Descriptive statistics were used to describe the results.
RESULTS: In our study, 6,177 CKD stage 5 patients received ESAs for ≥6 accounting quarters, of whom 64.4 % received originator ESAs, 21.1 % received biosimilars and 14.6 % received any sequence originator and biosimilar (total of 35.7 % any biosimilar). Patients receiving either originator short-acting ESAs, long-acting darbepoetin-alfa or M-PEG epoetin-beta had a median DDD consumption of 0.77, 0.81 and 0.90, respectively. Patients receiving a biosimilar short-acting ESA had a median DDD consumption of 0.82. Doses were not increased when the therapy was switched from the originator to the biosimilar ESA. These results were confirmed in 1,886 patients receiving a continuous prescription over 12 accounting quarters, with patients receiving short-acting originator ESAs, long-acting darbepoetin-alfa and biosimilar ESAs having a median daily DDD consumption of 0.80, 0.86 and 0.81, respectively.
CONCLUSIONS: We conclude that, based on a population based analysis, ESA consumption of patients on chronic haemodialysis is similar for biosimilar and originator ESAs.

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Year:  2012        PMID: 23052412     DOI: 10.1007/s00228-012-1412-5

Source DB:  PubMed          Journal:  Eur J Clin Pharmacol        ISSN: 0031-6970            Impact factor:   2.953


  21 in total

1.  Darbepoetin alpha in lower-than-equimolar doses maintains haemoglobin levels in stable haemodialysis patients converting from epoetin alpha/beta.

Authors:  H Andreas Bock; Patricia Hirt-Minkowski; Michel Brünisholz; Gerald Keusch; Simone Rey; Beat von Albertini
Journal:  Nephrol Dial Transplant       Date:  2007-09-22       Impact factor: 5.992

2.  Recombinant EPO production--points the nephrologist should know.

Authors:  Wolfgang Jelkmann
Journal:  Nephrol Dial Transplant       Date:  2007-06-25       Impact factor: 5.992

3.  Switch of ESA therapy from darbepoetin-alpha to epoetin-beta in hemodialysis patients: a single-center experience.

Authors:  P Biggar; M Ketteler; H Hennemann; R Dömling
Journal:  Clin Nephrol       Date:  2008-03       Impact factor: 0.975

4.  Comparison of the therapeutic effects of epoetin zeta to epoetin alfa in the maintenance phase of renal anaemia treatment.

Authors:  Volker Wizemann; Boleslaw Rutkowski; Conrad Baldamus; Paul Scigalla; Rossen Koytchev
Journal:  Curr Med Res Opin       Date:  2008-03       Impact factor: 2.580

5.  Once-monthly darbepoetin alfa for maintaining hemoglobin levels in older patients with chronic kidney disease.

Authors:  Anil Agarwal; Marcia R Silver; Michael Walczyk; Wei Liu; Paul Audhya
Journal:  J Am Med Dir Assoc       Date:  2006-09-29       Impact factor: 4.669

6.  Therapeutic equivalence, long-term efficacy and safety of HX575 in the treatment of anemia in chronic renal failure patients receiving hemodialysis.

Authors:  M Haag-Weber; A Vetter; U Thyroff-Friesinger
Journal:  Clin Nephrol       Date:  2009-11       Impact factor: 0.975

7.  Treatment of anaemia in dialysis patients with unit dosing of darbepoetin alfa at a reduced dose frequency relative to recombinant human erythropoietin (rHuEpo).

Authors:  Francesco Locatelli; Bernard Canaud; Francis Giacardy; Alejandro Martin-Malo; Nigel Baker; Janet Wilson
Journal:  Nephrol Dial Transplant       Date:  2003-02       Impact factor: 5.992

8.  Darbepoetin alfa effectively maintains haemoglobin concentrations at extended dose intervals relative to intravenous or subcutaneous recombinant human erythropoietin in dialysis patients.

Authors:  Reinhard Brunkhorst; Jürgen Bommer; Johann Braun; Marianne Haag-Weber; Caroline Gill; Jürgen Wagner; Thomas Wagener
Journal:  Nephrol Dial Transplant       Date:  2004-02-19       Impact factor: 5.992

9.  Recombinant human erythropoietin in anemic patients with end-stage renal disease. Results of a phase III multicenter clinical trial.

Authors:  J W Eschbach; M H Abdulhadi; J K Browne; B G Delano; M R Downing; J C Egrie; R W Evans; E A Friedman; S E Graber; N R Haley
Journal:  Ann Intern Med       Date:  1989-12-15       Impact factor: 25.391

10.  Bioequivalence of HX575 (recombinant human epoetin alfa) and a comparator epoetin alfa after multiple intravenous administrations: an open-label randomised controlled trial.

Authors:  Fritz Sörgel; Ursula Thyroff-Friesinger; Andrea Vetter; Bernhard Vens-Cappell; Martina Kinzig
Journal:  BMC Clin Pharmacol       Date:  2009-05-22
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  14 in total

1.  Effectiveness of Switch to Erythropoiesis-Stimulating Agent (ESA) Biosimilars versus Maintenance of ESA Originators in the Real-Life Setting: Matched-Control Study in Hemodialysis Patients.

Authors:  Roberto Minutolo; Piergiorgio Bolasco; Paolo Chiodini; Stefano Sposini; Maurizio Borzumati; Cataldo Abaterusso; Alessandra A Mele; Domenico Santoro; Valeria Canale; Alberto Santoboni; Oliviero Filiberti; Fulvio Fiorini; Carlo Mura; Patrizio Imperiali; Silvio Borrelli; Luigi Russo; Luca De Nicola; Domenico Russo
Journal:  Clin Drug Investig       Date:  2017-10       Impact factor: 2.859

2.  Formulary Selection Criteria for Biosimilars: Considerations for US Health-System Pharmacists.

Authors:  Niesha Griffith; Ali McBride; James G Stevenson; Larry Green
Journal:  Hosp Pharm       Date:  2014-10

3.  Comparative risk/benefit profile of biosimilar and originator erythropoiesis-stimulating agents (ESAs): data from an Italian observational study in nephrology.

Authors:  Domenico Motola; Alberto Vaccheri; Andrea Roncadori; Monia Donati; Giulia Bonaldo; Anna Covezzoli; Piera Polidori; Stefano Bianchi
Journal:  Eur J Clin Pharmacol       Date:  2018-02-10       Impact factor: 2.953

Review 4.  Differentiating factors between erythropoiesis-stimulating agents: an update to selection for anaemia of chronic kidney disease.

Authors:  Walter H Hörl
Journal:  Drugs       Date:  2013-02       Impact factor: 9.546

Review 5.  State-of-the-art biosimilar erythropoietins in the management of renal anemia: lessons learned from Europe and implications for US nephrologists.

Authors:  Adrian Covic; Ivo Abraham
Journal:  Int Urol Nephrol       Date:  2015-07-30       Impact factor: 2.370

Review 6.  HX575: established biosimilarity in the treatment of renal anemia and 10 years of clinical experience.

Authors:  Frank Dellanna; David Goldsmith; Andriy Krendyukov; Andreas Seidl; Nadja Höbel; Christian Combe
Journal:  Drug Des Devel Ther       Date:  2017-12-18       Impact factor: 4.162

7.  Comparative effectiveness and safety of erythropoiesis-stimulating agents (biosimilars vs originators) in clinical practice: a population-based cohort study in Italy.

Authors:  Francesco Trotta; Valeria Belleudi; Danilo Fusco; Laura Amato; Alessandra Mecozzi; Flavia Mayer; Massimo Sansone; Marina Davoli; Antonio Addis
Journal:  BMJ Open       Date:  2017-03-10       Impact factor: 2.692

8.  Pharmacoutilization of epoetins in naïve patients with hematological malignancies in an unselected Italian population under clinical practice setting: a comparative analysis between originator and biosimilars.

Authors:  Valentina Perrone; Stefania Saragoni; Stefano Buda; Alessandro Broccoli; Luca Degli Esposti
Journal:  Biologics       Date:  2016-12-01

Review 9.  Epoetin Biosimilars in the Treatment of Chemotherapy-Induced Anemia: 10 Years' Experience Gained.

Authors:  Matti Aapro; Andriy Krendyukov; Martin Schiestl; Pere Gascón
Journal:  BioDrugs       Date:  2018-04       Impact factor: 5.807

Review 10.  Biosimilarity and Interchangeability: Principles and Evidence: A Systematic Review.

Authors:  Ross A McKinnon; Matthew Cook; Winston Liauw; Mona Marabani; Ian C Marschner; Nicolle H Packer; Johannes B Prins
Journal:  BioDrugs       Date:  2018-02       Impact factor: 5.807

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