OBJECTIVES:The Affordable Care Act of 2010 defined a pathway for the authorization of biosimilar biologics by the Food and Drug Administration (FDA). This study assessed trends and compare biosimilars and reference biologic products prices in the US from the date of authorization to December 31, 2018.

METHODS:A list of biosimilars and reference biologics authorized by the FDA was extracted from the FDA Purple Book. Average wholesale prices (AWP) were extracted from the RedBook (IBM Inc.). Prices were adjusted to the first semester of 2018 using the consumer price index (CPI) from the US Bureau of Labor Statistics. Descriptive statistics were performed in the analysis. The AWP median prices at market entry and as of December 31, 2018 were calculated. The compound annual growth rate (CAGR) was calculated from date of market entry to December 31, 2018.

RESULTS:The FDA CDER authorized 12 biosimilar products for 7 therapeutic biologics as of December 31, 2018. AWP information was not available for the biosimilar versions of adalimumab, bevacizumab and trastuzumab. Biosimilar products entered the market with a median AWP of 67.0% of their respective reference product. Prices of reference biologic products increased in the period of analysis with a CARG of 1.9% for epoetin alfa, 4.2% for filgrastim, 4.6% for infliximab, and 6.1% for pegfilgrastim. However, the prices of biologic reference products after biosimilar entry only increased in the cases of filgrastim (CAGR=1.2%) and infliximab (CAGR=4.0%). Prices of biosimilars did not increase from the date of FDA authorization to December 31, 2018.

CONCLUSIONS:Prices of biosimilar entered the market lower than the prices of their respective reference biologics. Savings from biosimilar products derived from price reductions at market entry in comparison with their respective reference products and lower price increases post-biosimilar market entry.