Pegfilgrastim Biosimilars in US Supportive Oncology: A Narrative Review of Administration Options and Economic Considerations to Maximize Patient Benefit

Abstract

Granulocyte colony-stimulating factor (G-CSF) biologics, such as pegfilgrastim, are a standard of care in supportive cancer treatment that are administered once per chemotherapy cycle to reduce the incidence of febrile neutropenia. The high cost of these biologics in the United States can be a limiting factor to accessing care; however, lower-cost pegfilgrastim biosimilars have been available for several years for patients requiring prophylaxis of febrile neutropenia. Different options for pegfilgrastim administration are also now available to accommodate specific patient preferences. As patients may want to minimize the risk of both neutropenia and SARS-CoV-2 infection, same-day administration is a pertinent option during the present COVID-19 pandemic. Therefore, individualized, patient-centered approaches and risk-management strategies should be considered when selecting the treatment and administration method for prophylaxis of febrile neutropenia. Three methods of administration would minimize hospital or clinic visits while also providing the prophylactic effect of G-CSF: same-day administration after chemotherapy, use of the US Food and Drug Administration–approved on-body injector delivering pegfilgrastim approximately 27 h after chemotherapy, or self-administration by the patient or caregiver > 24 h after chemotherapy. Choice of the specific administration option should be based on the patient’s specific needs, while also considering mitigating factors, such as the economic burden associated with biologic medications and the risk of COVID-19. Pegfilgrastim biosimilars can minimize the additional financial burden on patients and the health care system during this pandemic and beyond.

A Randomized, Open-Label Study Conducted to Evaluate the Bioequivalence of Pegfilgrastim-cbqv On-Body Injector Versus Prefilled Syringe in Healthy Male Participants

“…Each method of administration has advantages and disadvantages, with specific benefits that appeal to different patients. The availability of more than one type of administration device allows the selection of the option that best fits user needs and preferences [ 16 , 26 – 28 ]. The benefits of using an OBI to administer pegfilgrastim-cbqv are twofold: (1) patients who are unable to self-inject using a PFS or autoinjector have an alternative method for which no intervention from the patient is necessary and (2) the need for a second health care visit to receive the recommended next-day administration of pegfilgrastim-cbqv is reduced.…”

“…The benefits of using an OBI to administer pegfilgrastim-cbqv are twofold: (1) patients who are unable to self-inject using a PFS or autoinjector have an alternative method for which no intervention from the patient is necessary and (2) the need for a second health care visit to receive the recommended next-day administration of pegfilgrastim-cbqv is reduced. Additionally, use of a pegfilgrastim-cbqv OBI could improve treatment adherence rates when used in patient groups who prefer not to self-inject [ 16 , 28 ]. In a previous study of G-CSF prophylaxis, administration using an OBI compared with a PFS was associated with improved treatment adherence (94.0% [95% CI 92.9–95.2] versus 58.4% [95% CI 55.2–61.5]) [ 29 ].…”

“…Although biologic medications such as pegfilgrastim have marked clinical benefit, biologics are associated with considerable cost [ 16 ]. Biosimilars are biologic drugs proven to be highly similar in potency, safety, and efficacy to the originator biologic (reference product) but available at a lower cost [ 17 ].…”

“…The dosage, route of administration, and conditions of use (i.e., indication and dosing regimen) of this new presentation are identical to those of the FDA-licensed pegfilgrastim-cbqv single-dose 6-mg PFS and the reference product pegfilgrastim [ 12 ]. The OBI provides an alternative for patients who are unable to self-administer the drug and reduces the need for a second health care visit to receive the recommended next-day administration of pegfilgrastim-cbqv [ 16 ]. The goal of the current study was to establish the pharmacokinetic (PK) bioequivalence of pegfilgrastim-cbqv OBI and pegfilgrastim-cbqv PFS and to assess the pharmacodynamic (PD) bioequivalence, the safety (including immunogenicity), and the tolerability of the OBI.…”

The impact of new and emerging agents on outcomes for febrile neutropenia: addressing clinical gaps

“…Biosimilar G-CSF use has shown noninferior outcomes with similar efficacy and safety data in real world populations, and usage in resource-limited settings is particularly attractive [22]. Innovative biosimilar administration even showed promise in improving patient outcomes and reducing infection exposure during the COVID-19 pandemic [23]. Although these findings are promising, real-world benefit will depend heavily on regulatory, marketplace, and provider factors.…”