Biosimilars offer great promises to payers and patients alike; these drugs exert near identical effects as expensive biologics, whilst offering considerable healthcare savings. However, the results of new analysis, conducted by researchers from the University of Minnesota and Mayo Clinic (both MN, USA), suggest that the cost savings offered by biosimilars are not always so uniform and substantial. Further, biosimilars are associated with a number of additional regulatory challenges and concerns.
Following the passages of the Biologics Price Competition and Innovation Act and Affordable Car Act – in 2009 and 2010 respectively – filgrastim-sndz became the first approved biosimilar product in the USA in 2015, based on the biologic filgrastim.
Frequently asked questions:
Previous research demonstrated that, following US approval of filgrastim-sndz, filgrastim uptake declined by 40% amongst Medicare patients. In this study, researchers employed anonymized claims data from commercial and Medicare Advantage insurance plans to identify the proportion of patients on private insurance or Medicare Advantage plans who were prescribed filgrastim-sndz and filgrastim, and the costs associated with each of these.
Researcher observed that prior to the approval of filgrastim-sndz, approximately 88% of prescriptions for treatments used to treat neutropenia were for filgrastim.
By 2018, this proportion of filgrastim prescriptions fell to 40%, with prescriptions for filgrastim-sndz accounting for 47% of all administrations instead.
In addition, at its time of market approval, filgrastim-sndz was 31% cheaper compared with filgrastim, for commercially insured patients. However, in 2018, filgrastim-sndz was only 23% cheaper than filgrastim.
Further, for individuals insured on Medicare Advantage plans, the costs of filgrastim compared to filgrastim-sndz were nearly identical at the time of filgrastim-sndz launch.
In reference to filgrastim-sndz approval, lead study author Pinar Karaca-Mandic (University of Minnesota) commented: “Biosimilar uptake was fast, and there were cost savings. However, there are still major barriers. For example, there are legal battles by originator biologics that delay the entry of biosimilars. In addition, originator biosimilars offer rebates to health plans to cover originator biologics as the preferred drugs in the health plan coverage policies.”
Karaca-Mandic P, Chang J, Go R, Schondelmeyer S, Weisdorf D, Jeffery MM. Biosimilar filgrastim uptake and costs among commercially insured, Medicare advantage. Health affairs. 38(11); (2019);
Biosimilars are near identical agents of biologic products, offering matched drug safety and efficacy and generating competition between drug producers. In instances of high demand, competition is the single most efficient means of driving down drug prices and increasing in-need patients’ access to therapies.
This Act, passed in 2009, amended the Public Health Service Act and created a simpler approval pathway for biosimilars of FDA-licensed biologics.