Frank Dellanna, MD, and colleagues reviewed the journey of HX575 from development to approval in Europe, and describe a decade of clinical experience in patients with CKD, as the history and experience with this biosimilar provides an excellent example of a successful demonstration of biosimilarity.
Erythropoiesis-stimulating agents (ESAs), such as recombinant human erythropoietin, are commonly used to treat anemia in patients with chronic kidney disease (CKD). In May 2017, the FDA’s Oncologic Drugs Advisory Committee voted favorably following its review of the proposed epoetin alfa biosimilar, Epoetin Hospira.
In Europe, however, the first biosimilar (HX575, Binocrit) to originator epoetin alfa (Epogen, Procrit) was approved by the European Medicines Agency (EMA) in 2007. Thus, there are already 10 years of clinical experience of this biosimilar to epoetin alfa. Frank Dellanna, MD, and colleagues reviewed the journey of HX575 from development to approval in Europe, and describe a decade of clinical experience in patients with CKD, as the history and experience with this biosimilar provides an excellent example of a successful demonstration of biosimilarity.
Like all biosimilar drugs in the research and development pipeline, HX575 (Sandoz GmbH, Kundl, Austria) proceeded through the many steps of an approval pathway in which it demonstrated biosimilarity through the totality of the evidence obtained in a comprehensive comparability exercise that involved extensive analytical characterization, nonclinical studies, and clinical studies—phase 1, phase 2, and phase 3 trials of the compound’s pharmacokinetics (PK), pharmacodynamics (PD), as well as confirmatory studies. Extensive clinical experience with HX575 over the last decade also confirms that it provides an effective treatment for anemia related to CKD, with a safety profile similar to those of other ESAs.
HX575 has generated more than 400,000 patient-years of experience worldwide in CKD and chemotherapy-induced anemia; with more widespread adoption, patient exposure and experience continues to increase.
The approval pathway for HX575 was as follows:
In conclusion, the successful approval and clinical use of more than 20 biosimilars in the European Union over the last decade affirms the integrity of the EMA’s biosimilar pathway, the researchers conclude.
Comparability exercises and extensive clinical experience over the last decade also confirm that HX575 provides an effective treatment for anemia related to CKD and its safety profile is similar to that of other ESAs. Growing clinical experience with EMA-approved biosimilars should offer additional reassurance to healthcare professionals and patients that these agents are as effective and well-tolerated as others in the therapeutic class.