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Bioavailability Section

Bioequivalence studies with metformin: comparability of reference tablets from different origins

V. Vlahov, U. Thyroff-Friesinger, R. Koytchev, N. Bakracheva and E. Gatchev

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Volume 43 p. 457 - 462

Abstract

V. Vlahov, U. Thyroff-Friesinger, R. Koytchev, N. Bakracheva and E. Gatchev

¹Chair of Clinical Pharmacology, Multidisciplinary Hospital for Active Treatment Queen Giovanna, Sofia, Bulgaria, ²HEXAL Pharmaforschung GmbH, Holzkirchen, and ³CCDRD AG, Neuenhagen, Germany
Background: The choice of an appropriate reference product is still a problem within the European Union. When no direct comparisons between originator products in different countries are available, registration authorities are sometimes only prepared to grant registration for a generic product on the basis of a comparison with the originator product in the respective country. The aim of the investigation was therefore to evaluate the bioequivalence of reference products from different origins in two different bioequivalence trials with the same test drug. Methods: Two separate bioequivalence trials were performed involving the oral administration of one test and two reference products containing 500 mg metformin. Both studies had a randomized, open, single-dose, three-period crossover design and were carried out in 24 healthy volunteers. The reference products in the first trial were Glucophage mite (Germany) and Diabex (Australia). In the second trial the reference drugs were Glucophage mite (France) and Glucophage mite (Switzerland). The results of each trial were analyzed regarding the bioequivalence of the respective reference drugs. Findings: The reference drugs in each of both trials were bioequivalent: the 90% confidence intervals for both AUC_{0 ? tlast} and C_max were entirely within the acceptance range for bioequivalence trials (0.80 ? 1.25 for both parameters). Interpretation: In the case of metformin, the reference products available in the countries examined were very similar. This retrospective analysis involving two studies, therefore, confirmed bioequivalence between these reference products.Correspondence to:
R. Koytchev CCDRD AG Fontanestra
Email: [email protected]

Biosimilars

Biosimilarity of HX575 (human recombinant epoetin alfa) and epoetin beta after multiple subcutaneous administration

F. Sörgel, U. Thyroff-Friesinger, A. Vetter, B. Vens-Cappell and M. Kinzig

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Volume 47 p. 391 - 401

Abstract

F. Sörgel¹, U. Thyroff-Friesinger², A. Vetter², B. Vens-Cappell³ and M. Kinzig¹

¹IBMP-Institute for Biomedical and Pharmaceutical Research, Nürnberg-Heroldsberg, ²Clinical Research, Hexal AG, Holzkirchen, and ³Scope International, Hamburg, Germany
Objective: To compare the steady-state pharmacokinetics and pharmacodynamics following multiple subcutaneous administration of a new erythropoiesis stimulating agent (HX575, Binocrit^®, Sandoz GmbH, Holzkirchen, Germany) with that of epoetin beta (NeoRecormon^®, Roche Ltd., Welwyn Garden City, UK). Methods: An open, randomized, parallel group study was conducted in 80 healthy adult males. Subjects were randomized to multiple subcutaneous doses of 100 IU/kg body weight of HX575 or epoetin beta three-times-weekly for 4 weeks. Serum epoetin concentrations were measured using an enzyme-linked immunosorbent assay (ELISA) and pharmacokinetic parameters for the two treatments were compared. The time course and area under the effect curve ratios of hematological characteristics were used as surrogate parameters for efficacy evaluation. Results: The pharmacokinetic profiles after multiple doses were similar for both treatments. HX575 was bioequivalent to epoetin beta with respect to the rate and extent of exposure of exogenous epoetin, as indicated by the ratios (90% confidence intervals) of AUC_tau (96.1 (86.4 – 106.9)) and C_max,ss (98.5 (85.2 – 113.9)). The hematological profiles of both treatments were similar as determined from the population mean curves and the AUEC_Hb ratio (90% confidence interval] (99.2 (97.7 – 100.7)), the primary endpoint of this study. Study medication was well tolerated with no clinically relevant differences between safety profiles of the treatments. Anti-epoetin antibodies were not detected at any time. Conclusions: HX575 and epoetin beta were bioequivalent with respect to their steady-state pharmacokinetic profile and pharmacodynamic action. These results support the conclusion that HX575 and epoetin beta will be equally efficacious and may be interchangeable as therapy.Correspondence to:
Prof. F. Sörgel
Department of Research
IBMP-Institute for Biomedical and Pharmaceutical Research
Paul-Ehrlich-Straße 19
90562 Nürnberg-Heroldsberg, Germany
Email: [email protected]

Original

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

M. Haag-Weber, A. Vetter and U. Thyroff-Friesinger for the INJ- Study Group

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Volume 72 (2009) p. 380 - 390

Abstract

M. Haag-Weber¹, A. Vetter² and U. Thyroff-Friesinger² for the INJ-⁹ Study Group

¹Kuratorium für Dialyse und Nierentransplantation e.V., Straubing, and ²Sandoz AG/Hexal AG, Holzkirchen, Germany
Background: The recombinant human epoetin-a HX575 (Sandoz Pharmaceuticals GmbH/Hexal AG, Holzkirchen, Germany) is the first biosimilar erythropoiesis-stimulating agent (ESA) with marketing authorization in Europe. The primary objective of the study was the evaluation of therapeutic equivalence in terms of hemoglobin (Hb) response of HX575 compared with the comparator product (EPREX^®/ ERYPO^®, Janssen-Cilag/Ortho Biotech, Neuss, Germany) in the long-term intravenous (i.v.) treatment of anemia in chronic renal failure patients on hemodialysis following a 1 : 1 dose conversion from the comparator product to HX575. Methods: Hemodialysis patients with Hb levels of 10.0 – 13.0 g/dl were randomized to either continue their current i.v. epoetin-a treatment or switch to HX575. During treatment, epoetin dosages were titrated to maintain Hb values. The primary endpoint was the difference between treatment groups in the mean absolute change of Hb levels between baseline and evaluation period (Weeks 25 – 28). Results: Therapeutic equivalence of HX575 and the comparator epoetin-alpha, assessed during the evaluation period, was statistically confirmed: mean changes in Hb levels were 0.15 ± 0.09 g/dl in the HX575 and 0.06 ± 0.12 g/dl in the comparator epoetin-a group, with a difference between groups of 0.08 g/dl (95% confidence interval: –0.17; 0.34). Hb levels and epoetin dosages remained stable throughout the entire study period of 56 weeks. The long-term safety profile of HX575 was similar to that of the comparator epoetin-alpha. No antibody formation was detected. Conclusions: The study demonstrated therapeutic equivalence of biosimilar HX575 to the comparator epoetin-a, together with a comparable safety profile.Correspondence to:
Prof. Dr. M. Haag-Weber
Kuratorium für Dialyse und Nierentransplantation e.V.
Elisabethstraße 23
94315 Straubing, Germany
Email: [email protected]

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