Report: Biosimilar Savings Have Grown, but Uptake Barriers Remain

A new report from the Association for Accessible Medicines (AAM) found that despite obstacles standing in the way of biosimilar uptake in the United States, savings from biosimilar are steadily growing and totaled $2.2 billion in 2019.

Additionally, biosimilars have achieved $4.5 billion in savings since 2010, which was when the Biologics Price Competition and Innovation Act containing the regulatory pathway for biologics was enacted.

Although biosimilar savings are growing, biosimilars still face several hurdles to uptake including lack of education, lack of reimbursements, anticompetitive practices by reference product companies, interchangeability restrictions, patent litigations and settlements, incentives to prescribe reference products, and payer formulary restrictions.

Since 2010, patients have had limited access to biosimilars. Currently, only 17 biosimilars out of the 28 FDA-approved products have launched on the US market, which could be limiting potential savings, according to the report.

“Biosimilars are projected to save America tens of billions of dollars over the next decade, but only if patients can access them….Greater use of these medicines…could generate even more savings,” wrote the authors of the report.

In the report, AAM detailed several ways to help biosimilars achieve more savings quicker.

Addressing Incentives Issues

The authors of report also discussed the lack of competition that currently exists in the US biologics’ market and called for Medicare Part D to be updated to encourage use of generics and biosimilars and include a dedicated tier for specialty generic and biosimilar medicines.

In an interview with The Center for Biosimilars®, Wayne Winegarden, PhD, senior fellow in business and economics at the Pacific Research Institute (PRI) and director of PRI’s Center for Medical Economics and Innovation discussed the importance for separate formulary tier lists for biosimilars.

“You can have certain types of criteria in terms of price discounts relative to originator price or anything you want to have in order to for a product to qualify for it. But in order to share the savings…patients, the payer, and practitioners have to benefit. And if we don't get everybody's incentives aligned to have the patient using the biosimilar, then something along that chain isn't going to work well,” said Winegarden.

Additionally, AAM called for the use of rebates for reference drugs to be eliminated as they exclude lower-priced generics and biosimilars from formulary coverage and incentivize the use of reference drugs.

AAM also suggested that state-regulated health plans should prioritize coverage of generics and biosimilars. Medicare programs tend to reward the use of reference products over lower-cost alternatives.

“Constructive policies, like ending Medicare policies that reward the use of higher-cost brand drugs, could enhance that growth as specialty medicines account for an increased share of pharmaceutical costs,” said Dan Leonard, the new CEO for the AAM, in the report.

Addressing Lack of Competitive Market

Although biosimilars are widely available in the European Union and have resulted in drastic reductions drug pricing, patent disputes and lack of competition have made it more difficult for the United States to achieve the same discounts.

“We believe…patients and payers should have choices in the marketplace, and competition from generic and biosimilar medicines gives them that choice,” wrote the authors of the report.

In the report, AAM called on policymakers to take steps to ensure a viable competitive market for biosimilars to improve access to lower-cost treatments and take action against patent disputes brought on by reference product manufacturers.

Also, AAM said that America’s trade policies should reflect US law that encourages a balance between supporting the development of innovator produces and promoting a competitive market by ensuring greater access to biosimilars and generic drugs.

“Unfortunately, this policy objective, included in the Bipartisan Congressional Trade Priorities and Accountability Act of 2015, is often absent in U.S. trade policy,” the authors wrote.

Reference

Association for Accessible Medicines. Securing our access and savings: 2020 generic drug and biosimilar access and savings in the US report. AAM website. Published September 29, 2020. Accessed September 30, 2020. https://accessiblemeds.org/sites/default/files/2020-09/AAM-2020-Generics-Biosimilars-Access-Savings-Report-US-Web.pdf.