Early adoption of biosimilar growth factors in supportive cancer care
Menée aux Etats-Unis à partir de données médico-administratives, cette étude observationnelle rétrospective analyse la toxicité et la survenue d'événements indésirables liés à l'utilisation d'agents biosimilaires, notamment ceux utilisés dans la prévention d'une neutropénie induite par la chimiothérapie
In 2010, the US Food and Drug Administration established an approval pathway for biosimilar agents, biological agents with an active ingredient highly similar to the reference biological agent, to facilitate drug competition and lower costs. It is unclear whether biosimilar drugs could yield large cost savings in the United States given the previously documented market and regulatory barriers. Moreover, few studies have investigated the real-world safety and effectiveness profile of biosimilar agents compared with that of brand-name (reference) biological agents. The colony-stimulating growth factors (CSF) filgrastim-sndz and tbo-filgrastim reduce risk of chemotherapy induced neutropenia and were the first biosimilar agents approved in the United States. We examined the incidence of febrile neutropenia (FN),CSF-related adverse events (AEs),and drug cost among commercially insured US patients with cancer treated with chemotherapy. Methods :This retrospective observational study analyzed administrative health claims data from a large commercially insured population. Only de identified data were used, and the study was exempt from review by an institutional review board. The study included commercially insured adults with cancer treated with chemotherapy who received reference filgrastim or biosimilar filgrastim from September 1, 2012, through April 30, 2017. Patients with atypical risk for FN (ie, those with previous bone marrow or stem cell transplant or prior FN) were excluded from the study. The population was divided into either biosimilar or reference filgrastim groups according to the earliest filgrastim use (index date) (...)