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.
The review, first presented in abstract form at the European Society for Medical Oncology’s 2017 meeting, appears in the December 2017 issue of Drug Design, Development and Therapy.
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.
Spanish Real-World Study: Adalimumab Biosimilar MSB11022 Safe, Effective in IBD
May 18th 2024A real-world study in Spain on inflammatory bowel disease (IBD) patients found no meaningful changes in clinical or biochemical markers or differences in effectiveness between the adalimumab originator and the biosimilar MSB11022 (Idacio; Fresenius Kabi) in adalimumab-naïve patients.
A New Chapter: How 2023 Will Shape the US Biosimilar Space for 2024 and Beyond
December 31st 2023On this episode of Not So Different, Cencora's Brian Biehn and Corey Ford take a look back at major policy and regulatory advancements in 2023 and how these changes will alter the space going forward.
The Subcutaneous Revolution: Zymfentra and the Future of IBD Care With Dr Andres Yarur
December 17th 2023On this episode of Not So Different, Andres Yarur, MD, a researcher and associate professor of medicine at Cedars-Sinai Medical Center, discusses the significance of the FDA approval for Zymfentra, the world's first subcutaneous infliximab product, for patients with inflammatory bowel disease (IBD).
Eye on Pharma: EU Ustekinumab Approval; New Golimumab Data; Evernorth Adds Humira Biosimilar
April 29th 2024The European Union gained a new ustekinumab biosimilar; Alvotech released positive results from a clinical trial evaluating a golimumab biosimilar and the reference products (Simponi and Simponi Aria), and Evernorth announced that it is set to cover an adalimumab biosimilar at zero cost to patients.