U.S. Food and Drug Administration Commissioner Marty Makary speaks during a news conference alongside U.S. Health and Human Services Secretary Robert F. Kennedy Jr. and Centers for Medicare & Medicaid Services Administrator Mehmet Oz discussing administrative plans to reduce drug costs, at the Department of Health and Human Services in Washington, DC, U.S., October 29, 2025.
Annabelle Gordon | Reuters
The Food and Drug Administration announced Wednesday that it will take steps to speed up the process of developing generic versions of complex biologic drugs, with the goal of increasing lower-cost competition for expensive drugs and lowering drug costs for Americans.
It’s the latest move by the Trump administration to curb the high cost of prescription drugs in the United States, where drug prices are two to three times higher than those in other developed countries.
The decision to support the development and approval of so-called biosimilars could be a blow to pharmaceutical companies, whose most profitable products are often biologics intended to treat serious and chronic diseases. The exact impact will depend on the drug manufacturer and its products.
In a statement Wednesday, a Department of Health and Human Services spokesperson said the law gives manufacturers 12 years of exclusivity for biologic drugs, which is a “primary determining factor in drug development decision-making.”
“No manufacturer should expect a monopoly or anything beyond what is legally granted,” the spokesperson said.
The FDA’s new reforms “will take five to eight years to bring a biosimilar to market and cut it in half,” the agency’s commissioner, Marty Makary, said at a news conference Wednesday.
During the event, HHS Secretary Robert F. Kennedy Jr. said the FDA had an “outdated and cumbersome approval process that has slowed the entry of biosimilars.” He said “even when [the drugs] are approved, current laws often prevent pharmacists or patients from substituting them with patients who would benefit from a more affordable option.
“All of this ends today, and the FDA is taking bold and decisive action to eliminate these barriers and open markets to real competition,” Kennedy said.
Biological products are made from living cells, which makes their manufacturing more complex than that of chemically derived drugs. Biologics have a special path to FDA approval, and it’s harder for generic drugmakers to sell cheaper versions because of high development costs and a tough regulatory environment.
Biologic drugs account for only 5% of prescriptions in the United States, but will account for 51% of total drug spending in 2024, according to an FDA release. FDA-approved biosimilars are as safe and effective as their brand-name counterparts, but their market share remains less than 20%, the agency added. The FDA said it has approved 76 biosimilars so far, which represents only a small fraction of the approved biologic drugs.
Kennedy said biosimilars cost on average half the price of their brand-name counterparts. Their entry into the market lowers the prices of branded drugs by an additional 25%, which is a “real relief for patients”, he added.
Generic biosimilars saved $20 billion in healthcare costs in the United States last year alone, the FDA said.
In a new draft guidance, the FDA has proposed major updates to simplify biosimilar studies. For example, the agency recommended that pharmaceutical companies may not need to conduct human studies directly comparing the biosimilar to a brand-name product. This research takes years and costs tens of millions of dollars.
Biosimilars have historically struggled to gain market share over their branded counterparts compared to generic copies of small-molecule drugs, which often come in pill form and can enter cells easily due to their low molecular weight.
The difference is that many biosimilars are not identical copies of brand-name biologic drugs, unlike generics.
In many cases, pharmacists cannot directly substitute a branded biologic product for a biosimilar when filling a prescription unless they are classified as “interchangeable” and this is permitted by state law.
But the FDA said Wednesday that it generally advises against requiring so-called “switching studies,” which 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 create public confusion about the safety of biosimilars,” the FDA said in a statement.