The FDA wants to speed up approval of generic drugs as Trump takes aim at drug costs
U.S. Food and Drug Administration Commissioner Marty Makary speaks during a press conference alongside U.S. Secretary of Health and Human Services Robert F. Kennedy Jr. and Centers for Medicare & Medicaid Services Administrator Mehmet Oz about government plans to reduce drug costs at the Department of Health and Human Services in Washington, DC, USA, October 29, 2025.
Annabelle Gordon | Reuters
The Food and Drug Administration said Wednesday it will take steps to speed up the process of developing generic versions of complex biologic drugs to increase competition for cheaper drugs and reduce drug costs for Americans.
It is the Trump administration’s latest move to curb the high cost of prescription drugs in the United States, where drug prices are two to three times higher than in other developed countries.
The move to support the development and approval of so-called biosimilars could be a blow to pharmaceutical companies, whose most profitable products are often biologics used to treat serious and chronic diseases. The exact effects depend on the drug manufacturer and its products.
In a statement Wednesday, a Health and Human Services Department spokesman said the law grants manufacturers 12 years of exclusivity for biologic drugs, which is a “key factor in drug development decision-making.”
“No manufacturer should expect a monopoly or anything else that goes beyond what is permitted by law,” the spokesman said.
The FDA’s new reforms “will take the five- to eight-year time frame to bring a biosimilar to market and cut it in half,” the agency’s commissioner, Marty Makary, said during a news conference Wednesday.
During the event, HHS Secretary Robert F. Kennedy Jr. said the FDA has an “outdated and burdensome approval process that is slowing the entry of biosimilars into the market.” He said, “Even if [the drugs] When medications are approved, existing laws often prevent pharmacists or patients from substituting them for patients who would benefit from a cheaper option.”
“This all ends today as the FDA takes bold, decisive action to break down these barriers and open markets to real competition,” Kennedy said.
Biological products are made with living cells, making production more complex than chemically produced drugs. Biologics have a unique path to FDA approval, and it is more difficult for generic drugmakers to sell cheaper versions due to high development costs and a difficult regulatory landscape.
According to an FDA press release, biologic drugs make up just 5% of prescriptions in the U.S. but will account for 51% of total drug spending in 2024. FDA-approved biosimilars are as safe and effective as their brand-name counterparts, but their market share remains below 20%, the agency added. The FDA said it has approved 76 biosimilars so far, representing only a small portion of approved biologic drugs.
Kennedy said biosimilars cost, on average, half the price of their brand-name counterparts. With their entry into the market, prices for branded drugs will fall by a further 25%, which will be a “real relief for patients”, he added.
Biosimilar generics saved $20 billion in U.S. health care costs last year alone, the FDA said.
In new draft guidance, the FDA proposed major updates to simplify biosimilar studies. For example, the agency recommended that conducting human studies that directly compare the biosimilar to a branded product may not be necessary for pharmaceutical companies. This research takes years and costs tens of millions of dollars.
Compared to generic copies of small molecule drugs, which are often delivered in pill form and can easily penetrate cells due to their low molecular weight, biosimilars have historically struggled to gain market share from their branded counterparts.
The difference is that many biosimilars are not identical copies of brand-name biological drugs, whereas generics are.
In many cases, pharmacists cannot directly substitute a biosimilar for a brand-name biologic when filling a prescription unless it is classified as “interchangeable” and this is permitted by law.
But the FDA said Wednesday that it generally advises against requiring so-called “switching studies” that determine whether biosimilars have that classification. This step is not required for generic copies of small molecule drugs.
“These additional studies may slow development and cause public confusion about the safety of biosimilars,” the FDA said in a news release.
