Epoetin Biosimilars in the Treatment of Renal Anemia: What Have We Learned from a Decade of European Experience?

Abstract

Biosimilars are biological medicines that are approved via stringently defined regulatory pathways on the basis that comparable safety, efficacy, and quality have been demonstrated to their reference medicine. The advantage of biosimilar drugs is that they may be less expensive than the reference medicine, allowing for greater patient access and cost savings in already stretched healthcare budgets. Biosimilar epoetins have been available in Europe for a decade. Complementing in vitro and preclinical characterization, and pharmacokinetic/pharmacodynamic studies, clinical trials provided the additional data needed to reassure European authorities that biosimilar epoetins were sufficiently similar to the reference epoetin to warrant approval. Post-approval, real-world studies have provided further evidence that biosimilar epoetins are an effective and well-tolerated option for the treatment of renal anemia, with ongoing pharmacovigilance and observational studies monitoring for any unexpected long-term signals that have not been identified in clinical development studies. As the evidence and experience with these products increase, many of the initial concerns are being alleviated. Nephrologists can be increasingly confident that European Medicines Agency-approved biosimilars offer high-quality, affordable, effective alternatives to existing reference medicines used to treat renal anemia, and may help yield cost savings and improve patient access.