Biosimilars Pathway Survives With ACA Ruling

In a 7-to-2 decision, the Supreme Court upheld the Affordable Care Act (ACA). The court ruled that the plaintiffs seeking to declare the law unconstitutional did not have standing, which means a provision of the law that gave rise to today’s biosimilars market will survive.

It is the third time the ACA has survived a constitutional challenge since it was signed in 2010. At issue in the case of California v Texas was whether the law’s individual mandate remained constitutional after Congress set the penalty to $0 in the 2017 tax overhaul bill.

Within the ACA is The Biologics Price Competition and Innovation Act (BPCIA), which is the foundation for biosimilar development.

“Upholding this law means that millions of patients will continue to have access to biosimilars – lower-cost options for life-saving brand name biologic therapies both now and in the future,” Meaghan Rose Smith, executive director of the Biosimilars Forum, said in a statement.

Competition from biosimilars has also lowered prices on reference products, researchers from Xcenda reported in a study released earlier this week. Without biosimilars, the cost of biologics was on track to increase by an average of 56%.

Uptake of biosimilars is increasing. In oncology, for example, some institutions are prioritizing efforts to switch to biosimilars. In a presentation at the annual meeting of the American Society of Clinical Oncology (ASCO) early this month, Texas Oncology discussed its efforts in 2020 to shift to biosimilars. Investigators said that in one month alone, this project reduced costs by $4 million with a 21% conversion for three biosimilars.

Rituxan (rituximab) biosimilar usage increased from 5% in January 2020 to 80% in December 2020. Avastin (bevacizumab) biosimilar usage increased from 9% in January to 88% in December, and Herceptin (trastuzumab) biosimilar usage increased 8% in January to 74% in December. Based on average selling price, the potential savings per administration is $550 for bevacizumab, $850 for trastuzumab, and $1,400 for rituximab.