Study Compares Uptake, Prices of Biosimilars in US vs 2 European Countries

As part of a real-world analysis, researchers found stark differences in the uptake and pricing patterns for biosimilars between the United States and 2 European countries that have national mechanisms for drug price negotiations, suggesting that more policies targeting anticompetitive practices are needed to boost biosimilar utilization.

“Policies for drug pricing negotiations in the US against anticompetitive practices of exclusionary contracts could allow biosimilars to enter the market sooner and at lower costs, which could result in lower health care costs and improved patient access. Awareness of biosimilars should be promoted to increase the uptake of biosimilars in all three countries,” the authors explained.

In the United States, biologics only make up 2% of prescriptions but account for 37% of net drug spending. Until recently, the federal government was not able to negotiate drug prices with companies. Although the Inflation Reduction Act will enable Medicare plans to negotiate as of January 2023, this will not apply to commercial plans. Additionally, aggressive patent lawsuits have postponed many companies’ launch dates for biosimilars, resulting in patients waiting for 15 biosimilars that are FDA-approved to enter the market.

In Europe, studies have shown that there are varying policies and biosimilar uptake between countries. On the other hand, the perceived levels of uptake and competition have not reached the level that was expected by 2022 in the United States. Policymakers in both regions have considered implementing legislation and regulatory reforms to promote biosimilar competition.

The study, published in JAMA Network Open, looked at reference biologics and biosimilars that were approved in the United States, Germany, and Switzerland through August 2020 and analyzed prices and sales data from January 1, 2011, to December 31, 2020. The data was collected from public and commercial databases and the researchers conducted their analysis from August 1, 2021 to February 28, 2022.

By number of biologics, the United States had 15 biosimilars for 6 reference products, Germany has 52 biosimilars for 15 reference products, and Switzerland had 28 biosimilars for 13 reference products. Some substances were exclude from the US sample because they were either approved before a biosimilar approval pathway existed or the had entered the market yet.

Biosimilar uptake increased in all 3 countries over time, but differences in uptake were observed. In the United States, uptake at 1 year post market entry was highest for bevacizumab biosimilars (36%) and lowest for infliximab biosimilars (3%). In Germany, uptake was highest for adalimumab biosimilars (48%) and lowest for insulin lispro biosimilars (2%). In Switzerland, rituximab biosimilars has the most successful uptake (25%) and insulin glargine biosimilars had the worst (1%).

Between the countries, uptake across biosimilars was the best in Germany followed by the United States and Switzerland. However, uptake rates grew the fastest in the United States during the first year after market launch.

The relative prices of biosimilars compared to their reference products was the highest in the United States. In the United States, the median monthly treatment costs for the biosimilars and their reference products as of October 2020 were $8987 and $11,503, respectively. In Germany, the median monthly costs were $932 for biosimilars and $1285 for reference products. In Switzerland they were $1351 and $1801 for biosimilars and reference products, respectively.

“This difference might be explained by the fact that European countries have more comprehensive mechanisms for drug price assessment and negotiation than the fragmented system in the US,” the researchers said.

Additionally, the authors noted that limited biosimilar availability has led to skepticism about the safety and efficacy of biosimilars. One survey found that over half of US physicians did not believe that biosimilars were appropriate for use in patients. The authors of the present analysis attributed the increased uptake over time as proof that biosimilar awareness is increasing.

The study had some limitations, including sales data may have been limited or underreported, the sample size was small, and that the authors did not account for rebates when analyzing the United States.

Reference

Carl DL, Laube Y, Serra-Burriel M, et al. Comparison of uptake and prices of biosimilars in the US, Germany, and Switzerland. JAMA Network Open. 2022;5(12):e2244670. doi:10.1001/jamanetworkopen.2022.44670