A study presented at the 2017 Annual Meeting of the American Society of Clinical Oncology (ASCO) found that there was no clinically meaningful difference when patients with breast cancer were switched from treatment with reference filgrastim (Neupogen) to EP2006, the first FDA-approved filgrastim biosimilar (marketed as Zarxio).
A study presented at the 2017 Annual Meeting of the American Society of Clinical Oncology (ASCO) found that there was no clinically meaningful difference when patients with breast cancer were switched from treatment with reference filgrastim (Neupogen) to EP2006, the first FDA-approved filgrastim biosimilar (marketed as Zarxio).
The phase 3, randomized, double-blind registration study sought to assess the safety and efficacy of alternating treatment with EP2006 and the reference filgrastim for the prevention of severe neutropenia in patients undergoing myelosuppressive chemotherapy in the neoadjuvant setting.
The study comprised 218 patients who received the reference filgrastim or its biosimilar together with 6 cycles of chemotherapy. The patients were randomized into 4 arms; 2 arms received only 1 of the treatment products, either the EP2006 or the reference, and did not switch treatments. 2 arms received alternating treatments of the biosimilar and reference product (or vice versa) over cycles 1 to 6. The analysis compared the safety and efficacy of the 2 treatments between the pooled switched groups and the unswitched reference group over cycles 2 to 6. The researchers pre-defined a margin with a 95% confidence interval (CI), to demonstrate non-inferiority of the biosimilar product in febrile neutropenia (FN) rates between the switched an unswitched groups, for treatment cycles 2 to 6.
A total of 107 patients switched treatment, while 51 patients received the reference product in all cycles. Baseline characteristics were similar between the 2 treatment groups. The incidence of FN for the switched group was 3.4%, compared with 0% in the group that received the reference product alone (95% CI, range -9.65 to 4.96), a rate that fell within the pre-defined margin. Only 1 patient (switched group) was hospitalized due to FN. Infections were noted in 9.3% of the switched group versus 9.9% of the reference group. Treatment emergent adverse events were reported in 42.1% of patients in the switched group versus 39.2% of the reference group. Musculoskeletal and connective tissue disorders related to treatment with filgrastim were noted in 35.5% of the switched group versus 39.2% of the reference group. No patients developed anti-drug antibodies during the study period.
The researchers concluded that there was no evidence of clinically meaningful differences when patients undergoing treatment for breast cancer were switched between biosimilar filgrastim and reference filgrastim, or vice versa.
Panelists Deliberate Strategies to Enhance Biosimilar Integration in Managed Care Spaces
November 13th 2023At the recent Academy of Managed Care Pharmacy Nexus meeting, panelists discussed the impact of introducing biosimilars in new medical fields, emphasizing the need for more education and collaboration to ensure their smooth integration into health care systems.
What AmerisourceBergen's Report Reveals About Payers, Biosimilar Pricing Trends
May 28th 2023On this episode of Not So Different, Tasmina Hydery and Brian Biehn from AmerisourceBergen discussed results from a recent survey, that were also presented at Asembia 2023, diving into the payer perspective on biosimilars and current pricing trends across the US biosimilar industry.
AMCP Nexus: Panelists Share Current Scope of Biosimilar Industry
October 26th 2023Panelists at the Academy of Managed Care Pharmacy (AMCP) Nexus meeting chronicled the current state of the US biosimilar market, including current policies impacting the market, recent regulatory decisions, and the developing arguments around requirements for clinical efficacy studies.
Abstracts Highlight Growing Comfortability With Trastuzumab Biosimilars in Breast Cancer
July 31st 2023Abstracts presented at the annual meeting of the American Society of Clinical Oncology (ASCO 2023) emphasized the safety and efficacy of a trastuzumab biosimilar in treating HER2-positive breast cancer and growing utilization of trastuzumab biosimilars over time.
Dose Rounding Can Reduce Drug Waste Costs Associated With Reference, Biosimilar Bevacizumab
June 19th 2023Implementing strategies, such as dose rounding, can offset the impact of drug waste and reduce the total cost of care for value-based programs, according to a recent study of practices participating in the Oncology Care Model.