U.S. Food and Drug Administration Secretary Marty McCully holds a press conference with U.S. Health and Human Services Secretary Robert F. Kennedy Jr. and Centers for Medicare and Medicaid Services Administrator Mehmet Oz to discuss the administration’s plan to reduce drug costs at the Department of Health and Human Services in Washington, DC, on October 29, 2025.
Annabelle Gordon Reuter
The Food and Drug Administration announced Wednesday that it will take steps to speed up the process of developing generic versions of complex biological drugs to promote cheaper competition for expensive drugs and lower drug costs for Americans.
This is the Trump administration’s latest move to curb high prescription drug costs 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 drug companies whose most profitable products are often biological products that treat serious chronic diseases. The exact effects vary depending on the pharmaceutical company and its product.
A Department of Health and Human Services spokesperson said in a statement Wednesday that the law gives manufacturers 12 years of exclusivity over biologics, which is a “key determining factor in drug development decisions.”
“No manufacturer should expect exclusivity or anything beyond what is legally permitted,” the spokesperson said.
The FDA’s new reforms “will take five to eight years to bring biosimilars to market and cut the amount in half,” FDA Commissioner Marty McCulley said at a press conference Wednesday.
During the event, Health Department Secretary Robert F. Kennedy Jr. said the FDA’s “outdated and cumbersome approval process is slowing the entry of biosimilars.” “Even if (a drug) is approved, current laws often prevent pharmacists and patients from substituting it for patients who would benefit from more affordable options,” he said.
“It all ends today. FDA is taking bold and decisive action to break down these barriers and open the market to real competition,” Kennedy said.
Biological products are engineered using living cells, making them more complex to manufacture than chemically derived drugs. Biologics have a special pathway to FDA approval, and high development costs and a difficult regulatory landscape make it difficult for generic drug manufacturers to sell cheaper versions.
Biologics make up only 5% of prescriptions in the U.S., but they will account for 51% of total drug spending by 2024, according to the FDA. FDA-approved biosimilars are as safe and effective as private-label biosimilars, but their market share remains less than 20%, the agency added. The FDA said it has approved 76 biosimilars to date, but only a fraction of the biologics approved.
Kennedy said biosimilars cost, on average, half the price of private label biosimilars. Their entry into the market will reduce the price of branded drugs by a further 25%, which will be a “real relief for patients”, he added.
According to the FDA, biosimilar generic drugs saved the United States $20 billion in health care costs last year alone.
In a new draft guidance, FDA proposed significant updates to simplify biosimilar research. For example, the agency recommended that drug companies may not need to conduct human studies that directly compare biosimilars and branded products. That research will take years and cost tens of millions of dollars.
Biosimilars have historically struggled to gain market share from their own branded products compared to generic copies of small molecule drugs, which often come in pill form and have lower molecular weights that allow them to more easily enter cells.
The difference is that many biosimilars are not identical copies of branded biological drugs, whereas generic drugs are.
In many cases, pharmacists cannot directly substitute a branded biologic for a biosimilar when filling a prescription unless it is classified as “interchangeable” and allowed by state law.
But the FDA said Wednesday that it generally recommends not requiring so-called “switcher trials” to determine whether a biosimilar falls under that classification. This step is not required for generic copies of small molecule drugs.
“These additional studies could delay development and cause public confusion about the safety of biosimilars,” the FDA said in a release.
