The U.S. biologics and biosimilars market is evolving rapidly, and the benefits for patient access and controlling health care costs will continue to grow over time as more medicines are introduced. As of November 2020, there are 18 biosimilars on the market in the U.S. competing against 7 reference biologics, with 10 additional FDA approved biosimilars due to come to market over the next several years.2 In FY 2020, there were 104 programs enrolled in the Biosimilar Product Development (BPD) Program.3 In addition to products for oncology, immunology, and multiple sclerosis, since the successful addition of the transition products to the biosimilar pathway in March 2020 it is now possible for manufacturers to develop biosimilars for diseases including diabetes, respiratory distress syndrome, fertility conditions, Cushing’s syndrome, deep vein thrombosis, Gaucher disease and many more.4 The rich pipeline of potential biosimilar and interchangeable products currently in development as well as current market experience indicates that there is still significant potential for cost savings in the United States market.
Many innovator medicines now compete with multiple biosimilar versions, with one biologic medicine currently facing competition from 5 biosimilars.5 The absolute savings from biosimilars vary with larger savings realized from more recent launches competing against more costly products. As of July 2020 the difference between the originator and the mean Average Sales Price (ASP) of their biosimilars ranged from 8.1% to 45.1% lower than the originator products (including insulins).6 In the Medicaid program, discounts increased by between 20.1 and 35.2 percentage points.7 Annualized savings from biosimilars reached $6.5B in the second quarter of 2020, and savings are modeled to exceed $100 billion in aggregate over the next five years.8
Biosimilars are also achieving significant market uptake, with the three most recently-launched biosimilars in 2019 achieving between 20% and 42% of market share within their first year.9 These trends suggest that uptake by doctors and patients of the coming wave of biosimilars will occur much more quickly than occurred for biosimilars launched earlier, in part due to increased education, awareness and experience among health care providers and patients.
2. PhRMA analysis of FDA, Biosimilar Product Information, https://www.fda.gov/drugs/biosimilars/biosimilar-product-information; IQVIA Institute, “Biosimilars in the United States 2020 – 2024,” (October 2020), https://www.iqvia.com/-/media/iqvia/pdfs/institute-reports/iqvia-institute-biosimilars-in-the-united-states.pdf?_=1606843358393
3. U.S. FDA. BsUFA Background and Reauthorization Process. November 19, 2020. Available at: https://www.fda.gov/media/143986/download
4. U.S. FDA (2020, March 23). Insulin Gains New Pathway to Increased Competition [Press release]. Retrieved from https://www.fda.gov/news-events/press-announcements/insulin-gains-new-pathway-increased-competition;
5. Fein, Adam. (2020). The Booming Biosimilar Market of 2020. Drug Channels. Retrieved from https://www.drugchannels.net/2020/10/the-booming-biosimilar-market-of-2020.html
6. IQVIA Institute Report (2020). Biosimilars in the United States 2020 – 2024. Retrieved from https://www.iqvia.com/-/media/iqvia/pdfs/institute-reports/iqvia-institute-biosimilars-in-the-united-states.pdf?_=1606843358393
7. San-Juan-Rodriguez A, Gellad WF, Good CB, Hernandez I. (2019) Trends in List Prices, Net Prices, and Discounts for Originator Biologics Facing Biosimilar Competition. JAMA Netw Open. 2(12):e1917379. Available at: doi:10.1001/jamanetworkopen.2019.1737
8. IQVIA Institute Report (2020). Biosimilars in the United States 2020 – 2024. Retrieved from https://www.iqvia.com/-/media/iqvia/pdfs/institute-reports/iqvia-institute-biosimilars-in-the-united-states.pdf?_=1606843358393