Erythropoietin is a protein secreted by the kidney that stimulates the production of red blood cells. Therapeutic erythropoietins (also known as erythropoiesis-stimulating agents) can be used to treat conditions in which there is a lack of red blood cells (anaemia), such as chronic kidney disease and cancer, and in people receiving chemotherapy. Therapeutic erythropoietins include epoetin alfa and darbepoetin alfa and are produced in cell culture using recombinant deoxyribonucleic acid (DNA) technology.

Biological epoetin treatments account for US$1.8 billion in drug spending each year worldwide. Biosimilar versions aim to reduce spending and increase accessibility. In the EU, there are five approved epoetin biosimilars, accounting for almost half of epoetin sales. In the US, the first epoetin biosimilar was approved in 2018, following two unsuccessful applications.

An article recently published in The Oncologist [1] reviews the use of biosimilar epoetin in the US. The authors reviewed peer-reviewed articles by searching a number of databases including MEDLINE (PubMed), Embase (Ovid) and Web of Science, as well as additional non-peer-reviewed literature identified through a Google search. They summarize the development and uptake of biosimilar epoetin in the US.

Following unsuccessful applications in 2015 and in 2017, the first biosimilar epoetin received US Food and Drug Administration (FDA) approval in May 2018. The biosimilar was approved on the basis of two randomized, double-blind clinical trials in patients with chronic kidney disease.

At its launch, the average wholesale price for biosimilar epoetin in the US was almost 60% less than the originator (Procrit). Its usage was also encouraged by some health insurance companies. In 2020, patients covered by UnitedHealthcare were required to switch to the epoetin biosimilar. Similarly, policy statements from AETNA and Humana indicated that all oncology patients beginning epoetin treatment must receive the biosimilar version (excluding a documented medical need).

Between 2018 and 2020, use of biosimilar epoetin varied widely in the US depending on hospital and insurer. The authors report that usage reached 81% among one private insurer’s patients covered by Medicare with cancer care administered by Oncology Analytics, and even reached 100% at a large county hospital in California. However, in other contexts usage was below 50% and in several Veterans Administration Hospital usage was 0%, the authors found.

The authors say the biggest barrier to uptake of biosimilar epoetin in the US is pricing. They suggest that small price discounts limited the use of biosimilar epoetin in some contexts. They also say that because no other epoetin biosimilars are currently under review by FDA, price competition is likely to be limited in the near future.

However, there have been some successful policies. For example, significantly discounted prices increased uptake of biosimilar epoetin by two national health insurers, thereby capturing most of the oncology market for the drug. The authors suggest that significant price discounts will enable continued increases in use of the biosimilar, as they have in the EU.

In addition to price, lack of understanding among providers and patients regarding substitution and interchangeability of biosimilar epoetin with other erythropoiesis-stimulating agents is an important issue.

The authors give a number of recommendations to improve uptake of biosimilar epoetin in the US, including:

• Educational programmes for physicians, patients, pharmacists and payers
• Policies to ensure that reference epoetin manufacturers allow biosimilar manufacturers access to samples
• Improved hospital, payer, pharmacy benefit manager pricing
• Making biosimilar epoetin eligible for pass-through payment status (reimbursements to improve access to new medicines)
• Transparent pricing to ensure that rebates focus on patient access and out-of-pocket costs over list price
• Federal Trade Commission action on patent infringement lawsuits that prevent the entry of new biosimilars
• Post-marketing safety and real-world data registries
• Allowing patients to share in the cost savings made through biosimilar usage through reduced out-of-pocket costs

Conflict of interest
The authors of the research paper [1] made a number of disclosures regarding funding. These can be read in full in the research paper.

Editor’s comment
Readers interested to learn more about epoetin and other oncology biosimilars are invited to visit www.gabi-journal.net to view the following manuscripts published in GaBI Journal:

Update on clinical practice guideline on the use of epoetin and darbepoetin in adult patients with cancer

Biosimilars in oncology: current and future perspectives

Repurposing non-oncology drugs for cancer treatment

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Reference
1. Bennett CL,Nagai S, Bennett AC, et al. The first 2 years of biosimilar epoetin for cancer and chemotherapy-induced anemia in the U.S.: a review from the Southern Network on Adverse Reactions. The Oncologist. 14 February 2021. doi:10.1002/onco.13713

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