Quality, safety and efficacy of the epoetin alfa biosimilar Binocrit compared to Erypo/Eprex

Biosimilars/Research | Posted 13/10/2009 post-comment0 Post your comment

A detailed checklist on the quality, safety and efficacy assessment of biopharmaceuticals was published by Professors Irene Krämer, Roger Tredree and Arnold Vulto in the 2008 EJHP Practice article Points to consider in the evaluation of biopharmaceuticals (Eur J Hosp Pharm Prac. 2008;14(1):73-6). The checklist was then used by Dr Carsten Brockmeyer and Dr Andreas Seidl of Sandoz/Hexal for Binocrit, the results of which were published in Eur J Hosp Pharm Prac. 2009;15(2):34-40.

Binocrit has been approved by EMEA for the major indications of treatment of anaemia in patients with chronic kidney disease (CKD) and chemotherapy-associated anaemia (CAA) in cancer patients. In their article, Drs Brockmeyer and Seidl consider questions on the Binocrit manufacturer, protein and product formulation, batch consistency, reliability of supply, good handling practice, clinical efficacy, clinical safety and tolerability, as well as reimbursement and efficacy.

They found that Binocrit and epoetin alfa have an identical amino acid sequence (primary structure) and comparable secondary and tertiary structures, with a similar isoform pattern and post-translational modification and no major differences in drug formulation. According to them, Binocrit “exceeds the reference product in its oxidised methionine content, solution clarity and silicon oil content in the drug product and [has] a better shelf life, due to the latest manufacturing techniques”. However, Binocrit contains more dimers and aggregates compared to Erypo/Eprex, which may be the cause for its increased immunogenicity and higher incidence of pure red cell aplasia (PRCA).

The clinical efficacy and safety of Binocrit versus the comparator epoetin alfa has been tested in two double-blind, randomised, multicentre, phase III studies in patients with CKD and CAA. The clinical safety of Binocrit was assessed in 98 healthy volunteers, 478 CKD patients and 114 cancer patients. Overall, Binocrit was well tolerated and adverse reactions were similar to those of Eprex. For IV-administered Binocrit in patients with anaemia who were receiving haemodialysis for CKD, an equivalent efficacy was found. For SC-administered Binocrit for CAA treatment of cancer patients, a comparable dose-response was found with similar dosing frequencies and total doses. In patients with CKD, no increased immunogenicity was found. None of the patients showed any signs of sudden haemoglobin or reticulocyte decrease or any other symptoms that would have been indicative of PRCA. In CAA patients no anti-recombinant human erythropoietin antibodies were detected and no patients showed signs of sudden haemoglobin or reticulocyte decrease. The bioequivalence of Binocrit was demonstrated, showing comparable pharmacokinetic and pharmacodynamic profiles in healthy volunteers, as well as clinical efficacy and safety profiles in patients with anaemia due to CKD and CAA. They conclude that pharmacists may trust the quality of biopharmaceuticals manufactured by Sandoz within the EMEA framework for biosimilars.

Source: Brockmeyer C, Seidl A. Binocrit: assessment of quality, safety and efficacy of biopharmaceuticals. Eur J Hosp Pharm Prac. 2009;15(2):34-40.

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