From the Journals

U.S. biosimilar competition, use, and availability still lags behind European countries


 

FROM JAMA NETWORK OPEN

The uptake and treatment costs of biosimilar drugs in the United States from 2011 to 2020 were significantly higher than in both Germany and Switzerland, based on data from a cohort study of publicly available commercial databases.

Biologics remain the fastest growing segment of drug research and development, but their costs remain high, David L. Carl, MSc, of the University of Zurich, and colleagues wrote in their study, published online in JAMA Network Open.

As patents and regulatory exclusivity periods expire, biologics face competition from biosimilars, which may drive competition and lower prices, they said.

“However, studies have shown that there are varying policies and biosimilar uptake in European countries and that the observed levels of competition and uptake have not reached the expected levels in the U.S.,” the researchers said.

To assist the discussions of policy makers in the United States and Europe as they consider legislative and regulatory reforms that are intended to promote the competition of biosimilars, the researchers reviewed data from 15 biosimilars and 6 biologics in the United States, 52 biosimilars and 15 biologics in Germany, and 28 biosimilars and 13 biologics in Switzerland.

They analyzed temporal trends in the uptake of biosimilars and their relative prices, compared with the prices of biologics in each country, by obtaining wholesale acquisition costs from online drug pricing databases. They extracted quarterly sales volume data for 2011-2020 from the IQVIA database. In the case of confidential rebates in Switzerland, the researchers obtained list prices.

Overall, the uptake of biosimilars increased in all three countries during the study period. However, the prices of biosimilars and the reference products were significantly higher in the United States, compared with Germany and Switzerland, both of which have national mechanisms for drug price negotiation. The monthly treatment cost of biosimilars was a median of 1.94 and 2.74 times higher in the United States than in Germany and Switzerland, respectively.

On average, the biosimilar market share at launch was highest in Germany; however, it increased at the fastest rate in the United States.

The findings were limited by several factors, including the sample size and the inclusion only of sales data provided by IQVIA, and by the use of list prices only without accounting for drug rebates, the researchers noted. Other limitations were the inability to compare conclusions from the United States and European Union directly because the drugs entered markets at different times, and not all the same drugs have been approved or designated as biosimilars, they said.

However, the results illustrate a difference in uptake of biosimilars in the United States with a reduced impact on drug costs, they said.

Looking ahead, “Policies for drug pricing negotiations in the U.S. 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,” they concluded.

The study was partially funded by the Swiss National Science Foundation. Lead author Mr. Carl had no financial conflicts to disclose; several coauthors disclosed funding from organizations including The Health Foundation, the U.K. National Institute for Health Research, and the Pharmaceutical Group of the European Union; all were unrelated to the current study.

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