ICYMI: FDA GUIDANCE PROMOTES ACCELERATED BIOSIMILAR DEVELOPMENT AND COMPETITION

Mar 11, 2026

Boosting Biosimilar Competition and Cracking Down on Big Pharma’s Egregious Patent Abuse Critical to Lowering Prescription Drug Prices

In case you missed it, the U.S. Food and Drug Administration (FDA) issued new guidance this week recommending more efficient testing standards designed to promote and expedite biosimilar drug development, a positive step toward increasing competition in the prescription drug market and lowering costs for patients. The guidance clarifies standards under the Biologics Price Competition and Innovation Act of 2009 (BPCI Act), removing targeted testing hurdles – a move that could significantly reduce barriers to fostering greater competition from more affordable alternatives to high-priced biologic drugs.

FDA Commissioner Marty Makary noted in the announcement that, “Streamlining biosimilar development reflects our ongoing commitment to lowering drug costs for everyday Americans. Using common sense, we are embracing more precise analytical testing approaches than have been used in the past.”

While generics and biosimilars are both alternatives to high-priced brand name drugs, biosimilars are alternatives for more complex biologic drugs and are not exact copies of branded drugs, like generics. As more biologics enter the prescription drug market, greater biosimilar competition is especially critical to bringing down costs for patients, taxpayers and the U.S. health care system.

Big Pharma’s egregious pricing practices and anti-competitive tactics continue to block more affordable alternatives like generics and biosimilars from reaching the market, driving rising health care costs.

The Administration’s new FDA guidance can help boost competition by streamlining biosimilar development. Congress should build on these first steps by advancing bipartisan, market-based solutions to crack down on Big Pharma’s patent abuse, eliminate barriers to greater competition and lower drug prices for American patients.

Learn more on how biosimilar competition reduces prescription drug costs and generates savings:

Generic and Biosimilar Savings in 2024: $467 Billion

A September 2025 report from the Association for Accessible Medicines (AAM), in partnership with the IQVIA Institute, details generic and biosimilar medications saved American patients and the U.S. health care system $467 billion in 2024 by reducing reliance on higher priced brand name drugs. The report noted savings over the last decade amounted to a staggering $3.4 trillion.

Generics and Biosimilars Make Up 90 Percent of All Prescriptions But Only 12 Percent of Spending

The same September 2025 rep o rt from AAM found that despite making up 90 percent of all prescriptions in the U.S. market, generic and biosimilar drugs accounted for only 12 percent of spending on all prescriptions.

Out of Pocket Costs for Biosimilars 23 Percent Lower Than Reference Biologics

A March 2024 study published in JAMA Network compared out-of-pocket spending between seven biologics and their biosimilar alternatives. The study found that in the commercial market, average patient out-of-pocket costs for the biosimilars were 23 percent lower compared their reference biologic, or around $200 less, on average. According to the study, “the mean [out-of-pocket] costs were lower for biosimilars ($707) than reference biologics ($911).”

Projected Savings of Greater Biosimilar Competition Between 2021 and 2025: $38.4 Billion

A July 2022 paper in the American Journal of Managed Care found that estimated savings from increased biosimilar competition and uptake could result in savings of $38.4 billion for the U.S. health care system. According to the paper’s authors, most of the expected savings will be driven “by downward pressure on the brand-name biologics they compete with.”

American Voters Broadly Support Improving Competition And Access To Biosimilars

A February 2025 national poll of U.S. voters, conducted By Fabrizio Ward on behalf of the Campaign for Sustainable Rx Pricing (CSRxP), found 82 percent of voters support “reform[ing] patent laws to prevent drug companies from abusing the system that extends their monopolies longer than intended and halts lower cost generic drugs and biosimilars from the market.”