Ten Years of Clinical Experience With Biosimilar Epoetin Alfa HX575

The epoetin alfa biosimilar HX575 (Binocrit, a product of Sandoz) was approved in the European Union in 2007 for the treatment of chemotherapy-induced anemia (CIA) and anemia associated with chronic renal failure. This biosimilar of the reference drug Epogen (Amgen) and Procrit (Janssen) stimulates an increase in red blood cell levels (erythropoiesis) and has been extensively used in real-world practice since its approval.

Matti S. Aapro, MD, and colleagues presented a poster session at the European Society for Medical Oncology 2017 meeting in Madrid, Spain, on September 10, 2017, on the development, approval, and 10 years of clinical experience with HX575. Sandoz provided funding for the research presented.

The poster explains that the development program for HX575 included extensive analytical characterization and comparison with reference epoetin alpha (Epogen), which confirmed the similarity of HX575 and reference epoetin alfa in terms of primary protein structure, higher-order protein structure, isoform pattern, post-translational modifications, receptor binding, and biological activity.

Phase 1 pharmacokinetic and pharmacodynamic studies demonstrated HX575’s bioequivalence to the reference medicine following intravenous and subcutaneous administration. A confirmatory phase 3 study in 114 cancer patients confirmed its therapeutic effectiveness in treating CIA, and showed that its safety profile was consistent with the therapeutic class and as expected for the therapeutic area.

Since the drug’s approval, numerous studies have tracked clinical experience with HX575 in a range of cancer types. As of February 2017, HX575 has generated over 252,000 patient years of experience in treating CIA worldwide, the researchers note. Accumulated data and experience over a decade of use are reassuring that HX575 is both effective and well tolerated in treatment of CIA in patients with different cancer types, the researchers conclude. Positive results have been reported from a multicenter retrospective clinical study, single-center studies from several countries, and a large-scale prospective observational study. No additional or unexpected safety issues have emerged after 10 years of pharmacovigilance. In addition, a pilot study has suggested that HX575 may be effective for the treatment of anemia in low- to intermediate-1 risk myelodysplastic syndromes.

According to Sandoz, its biosimilar pipeline includes an epoetin alpha biosimilar candidate, HX575, on which it has completed phase 2 trials in the United States for chronic kidney disease and CIA indications.

Reference

Aapro MS, Krendyukov A, Hobel N, Seidi A, Gascon P. Biosimilar epoetin alfa (HX575) for the treatment of chemotherapy-induced anaemia: development, approval and 10 years’ clinical experience. Presented at the European Society for Medical Oncology 2017 Congress; September 8-12, 2017; Madrid, Spain. Abstract 1594P. http://www.esmo.org/content/download/117241/2057634/file/ESMO-2017-Abstract-Book.pdf.