Uptake of biosimilars on the rise in the US, but number of marketed products lags other countries

Regulatory NewsRegulatory News | 05 December 2022 |  By 

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Fewer biosimilars have been marketed in the United States, compared with Germany and Switzerland, and prices are significantly higher in the US. However, biosimilars that have been introduced in the US recently had a stronger uptake than products that came on the market earlier.
These findings, published in JAMA Network Open, come from a cohort study evaluating market share and prices of biosimilars in the US, compared with Germany and Switzerland, which both have national mechanisms for drug price negotiation.
The study examined publicly available databases to identify all biologics and related biosimilars approved in the US, Germany, and Switzerland through August 2020 but products were only included in the analysis if at least one biosimilar had been marketed. Data on prices were extracted from January 2011 through December 2020. The researchers, led by Kerstin N. Vokinger, MD, PhD, of the University of Zurich, calculated the uptake (relative market share) and relative prices for all biosimilars compared with the reference biologic that shared the same active ingredient and used descriptive statistics to show temporal trends.
Overall, more biosimilars are marketed in Germany and Switzerland than in the US, despite comparable approval rates in the three countries. The study cohort included 15 biosimilars and 6 reference biologics in the US, 52 biosimilars and 15 reference biologics in Germany, and 28 biosimilars and 13 reference products in Switzerland.
The researchers suggested that biosimilar availability in the US was limited by ongoing patent litigation or agreements to defer entry as part of a patent dispute settlement. For example, reference biologics with the active ingredients bevacizumab, infliximab, or rituximab are protected by a median of 90 patents, researchers reported. Additionally, five adalimumab biosimilars have been approved in the US but none have been marketed because of patent dispute settlements. “Such extensive patenting of biologics incentivizes confidential litigation settlements in which manufacturers of biosimilars agree to not market their products years after FDA approval and after market entry in the European Union,” the researchers wrote.
Uptake of biosimilars increased across all three countries during the study, but the active ingredients with highest market share varied. For example, the highest uptake was for bevacizumab in the US, while adalimumab was highest in Germany, and rituximab was highest in Switzerland.
When researchers evaluated uptake of the six active ingredients with at least one biosimilar in all three countries, they found that biosimilar uptake was highest in Germany, followed by the US and Switzerland. However, market share was growing faster in the US than in the two European countries. “Biosimilars in the US that entered the market more recently were estimated to experience a faster uptake (as measured by the market share 1 year after launch), whereas in Germany and Switzerland the coefficients were small and not significant,” the researchers wrote.
The faster uptake could point to an increasing awareness of biosimilars in the US, but it is difficult to predict how future biosimilars will perform in the market given the limited number of marketed drugs in the analysis, the researchers explained.
When it comes to costs, US monthly treatment costs for both biosimilars and their reference products were significantly higher than in Germany and Switzerland. However, the relative prices of biosimilars versus the reference biologic were similar in the US and Switzerland and highest in Germany for the six active ingredients with at least one biosimilar marketed in all three countries.
The median monthly treatment costs per patient in the US as of October 2020 were $8,987 for included biosimilars and $11,503 for reference biologics. In Germany, those costs were $932 for biosimilars and $1,285 for reference biologics, while in Switzerland biosimilars cost $1,351 and reference biologics were $1,801.
“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,” the researchers wrote.
The study was partially funded by the Swiss National Science Foundation.
JAMA Network Open study


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