The United States has approved two biosimilars for etanercept (Enbrel) but patent litigation has delayed their market launch until 2029. Sales of Enbrel reached $4 billion in 2022, and the drug is being targeted for Medicare price negotiation under the Inflation Reduction Act. Meanwhile, Australia has been using the first etanercept biosimilar, Brenzys, since 2016, with the introduction of this drug triggering a 40% reduction in price for etanercept, leading to significant cost savings.
US Awaiting Launch of Enbrel Biosimilars; Australia Offers Cost Savings Example
Although 2 biosimilars of etanercept (Enbrel) have been approved in the United States, they are yet to hit the market due to patent litigation that extends till 2029. These biosimilars are expected to reduce the cost of the reference product, similar to other biosimilars that have already launched.
Despite Enbrel not earning as much as Humira, its 2022 sales crossed $4 billion. This presents significant cost-saving opportunities when cheaper alternatives become available. In the US, CMS chose Enbrel as one of the 10 drugs for Medicare price negotiation under the Inflation Reduction Act.
In Australia, the first etanercept biosimilar, Brenzys, became available in 2016. According to a study published in the Internal Medicine Journal, the treatment persistence was similar for the originator and biosimilars, due to a government pricing policy ensuring cost-minimization.
The authors of the study explained how the introduction of a biosimilar leads to statutory price reductions and creates competition, resulting in lower prices for both the originator and biosimilar drugs. This leads to cost savings and helps manage the rising healthcare costs in Australia.
For the study, data was analyzed from the Optimising Patient Outcomes in Rheumatology Australian real-world data set. It was observed that after the introduction of the biosimilar, the cost of treatment for the full eligible population dropped by an estimated AU$9.5 million (US$6.3 million) due to Australia’s pricing policy.
The researchers noted a rise in prescriptions for the biosimilar in Australia. However, they also observed a low rate of switching from the originator to the biosimilar.
Limitations of this study include its observational nature, which makes it susceptible to missing data and the lack of randomization.
Deakin CT, Littlejohn GO, Griffiths H, et al; OPAL consortium. Comparative effectiveness of etanercept originator and biosimilar for treating rheumatoid arthritis: implications for cost-savings. Intern Med J. Published online November 27, 2023. doi:10.1111/imj.16296