299
Views
1
CrossRef citations to date
0
Altmetric
Original Research

Comparison of Pharmacokinetic, Pharmacodynamic and Tolerability Profiles of CKD-11101, Darbepoetin Alfa (NESP®) Biosimilar, to Those of NESP® After a Single Subcutaneous or Intravenous Administration to Healthy Subjects

ORCID Icon, , ORCID Icon, , ORCID Icon, ORCID Icon, ORCID Icon & ORCID Icon show all
Pages 1735-1747 | Published online: 28 Apr 2021

References

  • JelkmannW. Physiology and pharmacology of erythropoietin. Transfusion Med Hemother. 2013;40(5):302–309. doi:10.1159/000356193
  • JonesM, IbelsL, SchenkelB, ZagariM. Impact of epoetin alfa on clinical end points in patients with chronic renal failure: a meta–analysis. Kidney Int. 2004;65(3):757–767.14871396
  • LeitgebC, PecherstorferM, FritzE, LudwigH. Quality of life in chronic anemia of cancer during treatment with recombinant human erythropoietin. Cancer. 1994;73(10):2535–2542.8174050
  • WilsonJ, YaoGL, RafteryJ, et al. A systematic review and economic evaluation of epoetin alpha, epoetin beta and darbepoetin alpha in anaemia associated with cancer, especially that attributable to cancer treatment. Health Technol Assess (Rockv). 2007;11(13):1–202, iii-iv.
  • MacdougallIC, RobertsDE, ColesGA, WilliamsJD. Clinical pharmacokinetics of epoetin (recombinant human erythropoietin). Clin Pharmacokinet. 1991;20(2):99–113.2029809
  • AllonM, KleinmanK, WalczykM, et al. Pharmacokinetics and pharmacodynamics of darbepoetin alfa and epoetin in patients undergoing dialysis. Clin Pharmacol Ther. 2002;72(5):546–555.12426518
  • PowellJ, Gurk-TurnerC. Darbepoetin alfa (Aranesp). Proceedings. 2002;15(3):332–335.
  • OverbayDK, ManleyHJ. Darbepoetin-alpha: a review of the literature. Pharmacotherapy. 2002;22(7):889–897.12126221
  • SiddiquiMA, KeatingGM. Darbepoetin alfa: a review of its use in the treatment of anaemia in patients with cancer receiving chemotherapy. Drugs. 2006;66(7):997–1012.16740021
  • ChristlLA, WoodcockJ, KozlowskiS. Biosimilars: the US regulatory framework. Annu Rev Med. 2017;68(1):243–254. doi:10.1146/annurev-med-051215-03102227813877
  • Wolff-HolzE, TiitsoK, VleminckxC, WeiseM. Evolution of the EU biosimilar framework: past and future. BioDrugs. 2019;33(6):621–634. doi:10.1007/s40259-019-00377-y31541400
  • HwangI, ParkS-I, LeeS, et al. Pharmacokinetics of fixed-dose combination of rosuvastatin 20 mg and ezetimibe 10 mg compared to concurrent administration of individual tablets in healthy Korean subjects. Transl Clin Pharmacol. 2017;68(1):16–24. doi:10.12793/tcp.2018.26.1.16
  • HwangJG, YooH, LeeJW, SongGS, LeeS, KimM-G. Comparison of pharmacokinetic characteristics of two Tegoprazan (CJ-12420) formulations in healthy male subjects. Transl Clin Pharmacol. 2019;27(2):80–85.32055586
  • Kim, Y-M, JeonJ-Y, MoonSJ, JungJ, SonH, KimM-G. Pharmacokinetics comparison of solifenacin tartrate and solifenacin succinate: a randomized, open-label, single-dose, 2-way crossover study in healthy male volunteers. Transl Clin Pharmacol. 2018;26(2):73–78.32055552
  • CheungWK, GoonBL, GuilfoyleMC, WacholtzMC. Pharmacokinetics and pharmacodynamics of recombinant human erythropoietin after single and multiple subcutaneous doses to healthy subjects. Clin Pharmacol Ther. 1998;64(4):412–423.9797798
  • AgoramB, SutjandraL, SullivanJT. Population pharmacokinetics of darbepoetin alfa in healthy subjects. Br J Clin Pharmacol. 2007;63(1):41–52.16939525
  • YoonS, RheeSJ, HeoSJ, et al. Comparable pharmacokinetics and pharmacodynamics of two epoetin alfa formulations Eporon((R)) and Eprex((R)) following a single subcutaneous administration in healthy male volunteers. Drug Des Devel Ther. 2017;11:3127–3135.
  • KimS, HongT, KoJW, HuhW, KimJR. Comparison of the pharmacokinetic-pharmacodynamic relationships of two darbepoetin alfa formulations in healthy male volunteers. BioDrugs. 2019;33(1):101–112.30506495
  • WheltonPK, CareyRM, AronowWS, et al. 2017 ACC/AHA/AAPA/ABC/ACPM/AGS/APhA/ASH/ASPC/NMA/PCNA guideline for the prevention, detection, evaluation, and management of high blood pressure in adults: a report of the American College of Cardiology/American Heart Association Task force on clinical practice guidelines. J Am Coll Cardiol. 2018;71(19):e127–e248.29146535
  • FlahartyKK, CaroJ, ErslevA, et al. Pharmacokinetics and erythropoietic response to human recombinant erythropoietin in healthy men. Clin Pharmacol Ther. 1990;47(5):557–564.2188770
  • McGowanT, VaccaroNM, BeaverJS, MassarellaJ, WolfsonM. Pharmacokinetic and pharmacodynamic profiles of extended dosing of epoetin alfa in anemic patients who have chronic kidney disease and are not on dialysis. Clin j Am Soc Nephrol. 2008;3(4):1006–1014.18417741
  • KimY, ParkSK, ChoWY, et al. Efficacy and safety of CKD-11101 (Proposed Biosimilar of Darbepoetin-Alfa) compared with darbepoetin-alfa in patients on hemodialysis: a randomized, double-blinded, Parallel-Group Phase III study. BioDrugs. 2019;34(1):99–110.
  • LeeJH, Ha ChungB, JooKW, et al. Efficacy and safety of CKD-11101 (darbepoetin-alfa proposed biosimilar) compared with NESP in anaemic chronic kidney disease patients not on dialysis. Curr Med Res Opin. 2019;35(6):1111–1118.30569763
  • LouizosC, YanezJA, ForrestML, DaviesNM. Understanding the hysteresis loop conundrum in pharmacokinetic/pharmacodynamic relationships. J Pharm Pharmaceutical Sci. 2014;17(1):34–91.
  • KoepkeJF, KoepkeJA. Reticulocytes. Clin Lab Haematol. 1986;8(3):169–179.3530617
  • RamakrishnanR, CheungWK, WacholtzMC, MintonN, JuskoWJ. Pharmacokinetic and pharmacodynamic modeling of recombinant human erythropoietin after single and multiple doses in healthy volunteers. J Clin Pharmacol. 2004;44(9):991–1002.15317827
  • KrzyzanskiW, JuskoWJ, WacholtzMC, MintonN, CheungWK. Pharmacokinetic and pharmacodynamic modeling of recombinant human erythropoietin after multiple subcutaneous doses in healthy subjects. Eur J Pharm Sci. 2005;26(3–4):295–306.16102948
  • OvchynnikovaE, AglialoroF, von LindernM, van den AkkerE. The shape shifting story of reticulocyte maturation. Front Physiol. 2018;9:829.30050448
  • Committee for Medicinal Products for Human Use (CHMP). Guideline on non-clinical and clinical development of similar biological medicinal products containing recombinant erythropoietins (Revision). Available from: http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2010/04/WC500089474.pdf. 2010. Accessed 61 2015.