NCT04971304

Comparative Effectiveness Analysis of Granulocyte Colony Stimulating Factor Originator Products Versus Biosimilars

An Exploratory Comparative Effectiveness Analysis of Granulocyte Colony Stimulating Factor Originator Products Versus Biosimilars in Real-world Practice

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 16,506 (actual)
• Sponsor: Catherine M. Lockhart · Academic / Other
• Sex: All
• Age: 20 Years
• Healthy volunteers: Not accepted

Summary

This comparative effectiveness and descriptive retrospective cohort study will evaluate safety and effectiveness outcomes among commercially insured adults who received a granulocyte colony stimulating factor (G-CSF) biosimilar or originator product during the first cycle of clinical guideline-indicated intermediate or high febrile neutropenia risk chemotherapy.

Detailed description

This comparative effectiveness and descriptive retrospective cohort study includes commercially insured adults enrolled in one of four health plans participating in the Biologics and Biosimilars Collective Intelligence Consortium (BBCIC) Distributed Research Network. The investigators included patients who received a granulocyte colony stimulating factor (G-CSF) biosimilar or originator product during the first cycle of clinical guideline-indicated intermediate or high febrile neutropenia risk chemotherapy. The investigators will collect patient demographics, cancer diagnosis, chemotherapy regimen, and patterns of G-CSF biosimilar and originator product use. The investigators will follow patients from first G-CSF exposure until up to six cycles of chemotherapy receipt, death, or insurance disenrollment. The primary effectiveness outcome is incidence of febrile neutropenia. Secondary outcomes include incidence of adverse events and trends in product use over time. The investigators will compare febrile neutropenia incidence between originator and biosimilar products using inverse probability weighting to control for confounding. Secondary analyses will examine 'as treated' outcomes.

Conditions

• Cancer, Breast
• Cancer, Lung
• Cancer of Colon
• Cancer of Pancreas
• Cancer, Ovarian
• Lymphoma, Non-Hodgkin

Interventions

Type	Name	Description
DRUG	Receipt of granulocyte-colony stimulating factor	Receipt of originator or biosimilar

Timeline

• Start date: 2015-03-01
• Primary completion: 2022-09-30
• Completion: 2022-12-31
• First posted: 2021-07-21
• Last updated: 2023-07-27

Regulatory

• FDA-regulated drug study