PRICES OF BIOSIMILARS IN THE US

• Published in: Value in health 2017-05, Vol.20 (5), p.A33
• Main Authors: Gannu, L, Daniels, K, Seoane-Vazquez, E, Szeinbach, SL
• Format: Article
• Language: English
• Subjects: Averages; Biological products; Etanercept; FDA approval; Infliximab; Market entry; Medicare; Monoclonal antibodies; Price increases; Prices; Producer prices; Sales; Savings; Tumor necrosis factor-α
• ISSN: 1098-3015; 1524-4733
• DOI: 10.1016/j.jval.2017.05.005

OBJECTIVES: The Affordable Care Act of 2010 defined a pathway for the approval of biosimilar biologic drugs by the FDA. This study assessed trends in prices of biosimilars and biologic drugs in the US as of January 1, 2017. METHODS: A list of biosimilars and therapeutic biologics approved in the US was extracted from the FDA webpage. Average wholesale prices (AWP) were extracted from the RedBook (Truven Health). Average sales price (ASP) used for Medicare Part B reimbursement was collected from the CMS. Descriptive statistics were conducted in the study. RESULTS: The FDA approved a total of 4 biosimilar drugs for therapeutic biologics as of January 1, 2017. The single source life of the originator biologic drugs from initial approval to first biosimilar approval was 13.7 years for adalimumab, 17.6 infliximab, 17.8 etanercept, and 24.0 filgrastim. Infliximab biosimilar entered the market with an AWP representing 88.3% of the biologic originator. The AWP of the infliximab originator continued to increase, and the biosimilar represented 85.0% of the originator in Jan 1, 2017. The infliximab biosimilar had an ASP price of 122.0% of the originator biologic ASP at market entry. Filgrastim biosimilar entered the market with an AWP representing 85.9% of the originator biologic. The filgrastim biosimilar had an ASP price of 97.0% of the corresponding originator biologic in October 1, 2015, and decrease to 71.0% in January 1, 2017. Prices for adalimumab and etanercept were not available. CONCLUSIONS: Biosimilar prices at market entry were equal or higher than the prices of the corresponding biologics. The ASP for the originator filgrastim remained constant after biosimilar entry, while the ASP for the biosimilar declined. Savings from biosimilars could results from lower biosimilar prices at market entry and from lower biologic and biosimilar price increases.