Pegfilgrastim biosimilars in US supportive oncology

Biosimilares/Investigación | Posted 13/01/2023 post-comment0 Post your comment

Humphreys et al. published a narrative review article concerning the administration options and the economic considerations of biosimilar pegfilgrastim in supportive cancer treatment in the US to maximize patient benefit[1].

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Febrile neutropenia is a serious complication of myelosuppressive chemotherapy, with potentially fatal outcomes and a high economic burden. International guidelines recommend the administration of long-acting granulocyte colony-stimulating factors such as pegfilgrastim for prophylaxis of febrile neutropenia.

Because pegfilgrastim is a biological, the high cost associated with biologicals can be a limiting factor to accessing care; biosimilars can provide a more affordable treatment option. Six pegfilgrastim biosimilars are approved in the US, and use of these biosimilars can result in significant savings. In a 2021 report, it was suggested that in the absence of biosimilar competition, the average sales price of reference pegfilgrastim would have been expected to increase by ~96%. However, some barriers to biosimilar use have been identified, such as drug rebate walls, challenges associated with Medicare reimbursement, and confusion about interchangeability between the originator and the biosimilar.

Different administration options for pegfilgrastim are available to accommodate individual patient preferences. Although next-day pegfilgrastim administration is indicated by the US Food and Drug Administration and current guidelines, minimizing the number of clinic visits is also important during the COVID-19 pandemic. Three options are available to reduce the number of clinic visits for next-day pegfilgrastim administration. One option is next-day self-administration by the patient or caregiver; however, barriers to self-injection include needle phobia, impaired manual dexterity, and using incorrect self-injection techniques. The second option is the use of an on-body injector (OBI) to deliver pegfilgrastim ~27 hours after chemotherapy, which is ideal for patients unable to self-administer. Unfortunately, reports of OBI failure (estimated rates between 1.7% and 6.9%) complicate use, and costs can be high because a biosimilar pegfilgrastim version delivered via OBI is not available. Same-day injection of pegfilgrastim (off-label) is another administration option that could be preferable for patients unable to self-inject and who are uncomfortable having an OBI attached to their skin. However, same-day use must be weighed against the potential for increased risk of febrile neutropenia in certain settings.

The choice of pegfilgrastim administration option should be based on the patient’s specific needs, while considering mitigating factors such as the risk of COVID-19 and the cost. Patients with cancer are generally at increased risk of infection compared with healthy individuals; therefore, the number of outpatient visits should be minimized. Pegfilgrastim biosimilars are important treatment options to minimize the financial burden on patients and the healthcare system during the COVID-19 pandemic and beyond.

Conflict of interest
The author of the research paper, Sophia Humphreys, has received honoraria from Coherus BioSciences and Mylan for speaking engagements unrelated to the current study.

Abstracted by Sophia Humphreys, Sutter Health, Sacramento, CA, USA.

Editor’s comment
Readers interested to learn more about biosimilars in oncology are invited to visit to view the following manuscript published in GaBI Journal:

Biosimilars in oncology: current and future perspectives

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1. Humphreys SZ, Geller RB, Walden P. Pegfilgrastim biosimilars in US supportive oncology: a narrative review of administration options and economic considerations to maximize patient benefit. Oncol Ther. 2022.

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