Addressing the high cost of health care is at the center of the Trump Administration’s policy agenda. Promoting Most Favored Nations pricing for pharmaceuticals, developing Trump RX, expanding consumer choice, and increasing price transparency are all aimed at one goal: making health care more affordable for Americans.
The Food and Drug Administration (FDA) has added another tool to that effort: more competition. In October 2025, and again in March 2026, the agency announced recommendations designed to streamline approval of biosimilar medicines—lower-cost alternatives to some of the most expensive drugs in the American health system.
Biologic medicines treat cancer, autoimmune disorders, many rare diseases and more. They are also among the most expensive therapies on the market, often costing tens of thousands—or even hundreds of thousands—of dollars each year.
Biosimilars are like generic drugs. Traditional generics replicate small-molecule medicines such as pills, while biosimilars are highly similar and have no clinically meaningful differences from complex biologic therapies derived from living cells. These products represent one of the fastest-growing—and costliest—segments of the pharmaceutical market. Although biologics account for only about 5% of prescriptions, they represent roughly half of total U.S. drug spending.
Congress first authorized biosimilars in 2010 through the Biologics Price Competition and Innovation Act. Lawmakers expected the new pathway to spark competition and push prices downward, much as generics did decades earlier. Instead, regulatory complexity, patent litigation, and costly development slowed progress.
The FDA’s recent recommendations aim to change that.
Because of advances in regulatory science, biosimilar developers will no longer need to repeat certain pharmacokinetic and clinical studies when existing scientific evidence already demonstrates biosimilarity or interchangeability. The agency will also allow companies to rely on testing with comparable medicines approved abroad without requiring unnecessary U.S. comparison studies, where scientifically appropriate.
These changes may sound technical, but their effects could be significant. For years the biosimilar pathway has resembled a narrow mountain pass—scientifically sound but clogged with regulatory boulders. The FDA has now begun clearing the road.
In a recent Journal of the American Medical Association Viewpoint, FDA Commissioner Marty Makary rightly underscored the need for stronger biosimilar competition. Despite years of policy discussion, the United States had approved only 82 biosimilar products in nearly two decades. A recent study found that biosimilars account for just 23% of the biologics market where they compete — “an indication that the goals of the BPCIA have fallen short for patients in the U.S.,” Makary wrote.
Competition is an incredibly effective tool to address high drug prices. A 2025 study by the Association for Accessible Medicines found that biosimilars typically enter the market at prices about 40% below their biologic counterparts, forcing brand-name competitors to respond.
The FDA’s new guidance could accelerate that dynamic. Makary notes that bringing a biosimilar to market currently takes five to eight years and costs between $100 million and $300 million. The updated regulatory approach could cut as much as $150 million from development costs and shave two to four years from the process.
Lower development costs ultimately mean more affordable prices for patients, faster.
Or put another way: when competition grows, prices fall—and when prices fall, competition grows – and Americans benefit.
Critics argue that faster approvals could compromise safety. That concern misunderstands what the FDA is doing. The announced recommendations do not weaken scientific standards. They remove unnecessary steps that add time and cost without improving patient protection. Modern analytical testing and clinical data using global products already provide powerful evidence of biosimilarity.
The FDA’s biosimilar initiative also fits squarely within the Trump Administration’s broader strategy to lower drug prices through market competition. Expanding supply, improving price transparency, and eliminating unnecessary regulatory barriers all move policy in the same direction – lower costs and more affordability.
Congress has also expressed interest in promoting greater utilization of biosimilars, including codifying many of these critical changes FDA is making and we look forward to working Congress achieving this objective. Ensuring these competitive medicines are treated fairly on health insurance formularies and removing barriers to pharmacies prescribing them is another area of potential reforms.
Health-care markets sometimes resemble dense forests where regulation grows thick and competition struggles to break through. The FDA’s guidance is a controlled burn—clearing outdated recommendations so new competitors can grow.
In the end, the principle is straightforward: we should not regulate competition out of the market; we should regulate the market so competition can thrive.
The FDA’s decision moves the country closer to that goal—and it deserves broad support.
The writer is the Assistant Secretary for Legislation at the U.S. Department of Health and Human Services
