Biologic drugs, which include therapeutic proteins and monoclonal antibodies, are large complex molecules typically manufactured in genetically engineered organisms.1 Although very effective, biologics are currently among the most expensive prescription drugs in the United States, creating barriers to patient access to potentially life-saving treatments and placing a significant burden on the healthcare system.1
The Biologics Price Competition and Innovation Act, enacted as part of the 2010 Patient Protection and Affordable Care Act, authorized the FDA to create a new regulatory approval pathway for biosimilars, which are biologic drugs that are very similar to already approved “reference” biologics in terms of potency, safety, and efficacy, but are manufactured by different companies.2,3
The following provides a brief look at some of the key statistics showing the role of biosimilars in providing value-based care in oncology.
Total spending on cancer care in the United States was $183 billion in 2015 and is projected to increase 34% to $246 billion by 2020, based solely on population growth.4
The high prices associated with biologics—often in excess of $100,000 per patient per year—have driven persistent growth in prescription drug spending.1
In the United States, biologics account for 38% to 40% of all pharmaceutical spending, but fewer than 2% of Americans use them.1
Biosimilars have been associated with $37 billion in savings across all therapeutic areas where they have been introduced since the passage of the BPCIA, and are projected to result in an estimated $104 billion in savings from 2020 to 2024.5
The 3 most recent biosimilars launched in 2019, bevacizumab-awwb (Mvasi), trastuzumab-anns (Kanjinti), and rituximab-pvvr (Ruxience), have seen average sales price reductions of $500 to $1900 for a standard course of treatment.5
The availability and use of biosimilars have accelerated and are on track to reduce drug costs by $100 billion over the next 5 years.5
- Zhai MZ, Sarpatwari A, Kesselheim AS. Why are biosimilars not living up to their promise in the US? AMA J Ethics. 2019;21:E668-E678.
- Carver KH, Elikan J, Lietzan E. An unofficial legislative history of the Biologics Price Competition and Innovation Act of 2009. Food Drug Law J. 2010;65:671-818.
- Koballa KE. The Biologics Price Competition and Innovation Act: is a generic market for biologics attainable? William & Mary Business Law Review. 2018;9:479-520.
- Mariotto AB, Enewold L, Zhao J, et al. Medical care costs associated with cancer survivorship in the United States. Cancer Epidemiol Biomarkers Prev. 2020;29:1304-1312.
- IQVIA. Biosimilars in the United States 2020-2024. October 2020. www.iqvia.com/insights/the-iqvia-institute/reports/biosimilars-in-the-united-states-2020-2024. Accessed October 22, 2021.