A Policy Pathway to Expanding Access to More Affordable Treatments for Americans

As efforts to protect the public health of the American people dominate conversations in the U.S. Capitol building, state legislatures and living rooms around the country, we must not lose sight of how we can bring innovative and more affordable prescription drugs to patients in need. 

Federal lawmakers should remain committed to finding solutions that ease the burden of prescription drug costs for patients and families and should support policies that expand access to affordable biosimilar treatments, and the president’s budget provides the resources to do so.

A biosimilar is a highly similar version of its original biological product, a treatment that is made from living organisms. Biologics are often used to treat some of the most complex health conditions, including cancer, psoriasis and asthma.

Biosimilars have no clinically meaningful differences from their original biologic and are approved by the Food and Drug Administration based on the agency’s rigorous standards for safety, effectiveness and purity. Today, there are 26 FDA-approved biosimilars to treat a variety of conditions, including arthritis, cancer and serious skin conditions.

In 2019 alone, the FDA approved 10 biosimilars, a single-year record for the agency. These innovative, cost-effective treatments have the potential to make a significant difference in many patients’ lives and save patients and taxpayers alike billions in health care costs.

According to one analysis from the RAND Corporation, introducing biosimilar treatments for complex conditions such as cancer and rheumatoid arthritis could cut U.S. health care spending by as much as $54 billion over the next decade. According to data from IQVIA, biologics today account for 2 percent of all prescription drugs in the United States but nearly 40 percent of total drug spending. Biosimilars, on the other hand, tend to come to market at a significantly lower price than their biologic counterpart.

Various factors, including an anti-competitive drug marketplace and lack of understanding and education around the safety and efficacy of biosimilars, have kept these life-saving drugs away from patients who need them the most. But recent activity at the federal level is reason to believe there is a policy pathway to expand access to biosimilars for more patients.

First, this February, the FDA and the Federal Trade Commission announced a new collaboration to support appropriate adoption of biosimilars, deter false or misleading statements about biosimilars, and deter anticompetitive behavior in this industry. The FDA and FTC already held the first all-day public workshop on the initiative this March.

Second, President Donald Trump released the Fiscal Year 2021 budget for the Department of Health and Human Services that includes federal resources to drive policy in the area of prescription drug pricing. The HHS budget includes a $135 billion allowance to support the president’s commitment to lower the cost of prescription drugs that Congress can use to support new federal policies, among them increasing marketplace competition for biosimilars.

Work remains to provide financial relief to patients who rely on prescription drugs to manage their health. Affordable biosimilars could be used to treat some of the most complex diseases we know while increasing competition in the health care marketplace to the benefit of the American people.

The president has given policymakers the resources to free up the marketplace to make these treatments for cancer, diabetes, arthritis and other conditions more available to those who need them. It’s time to invest in biosimilars and give patients more affordable treatment options.


Dr. Sal Giorgianni is a practicing pharmacist and senior science adviser to Men’s Health Network.

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