U.S. Food and Drug Administration Commissioner Marty Makary speaks during a property league alongside U.S. Secretary of Health and Human Services Robert F. Kennedy Jr., and Centers for Medicare & Medicaid Services Administrator Mehmet Oz, discussing medication plans to little cause costs, astatine the Department of Health and Human Services successful Washington, D.C., U.S., Oct. 29, 2025.
Annabelle Gordon | Reuters
The Food and Drug Administration connected Wednesday said it volition take steps to velocity up the process of processing generic versions of analyzable biologic drugs, successful a bid to summation cheaper contention for costly medicines and lower cause costs for Americans.
It's the Trump administration's latest determination to rein successful precocious medicine cause costs successful the U.S., wherever medicine prices are two-to-three times higher than those successful different developed nations.
The determination to enactment the improvement and support of alleged biosimilars could beryllium a stroke to pharmaceutical companies, whose astir profitable products are often biologic products that dainty superior and chronic diseases. The nonstop interaction volition beryllium connected the drugmaker and its products.
The FDA's caller reforms "will instrumentality the five-to-eight twelvemonth timeframe to bring a biosimilar to marketplace and chopped it successful half," the agency's Commissioner Marty Makary said during a property league connected Wednesday.
During the event, Health and Human Services Secretary Robert F. Kennedy Jr. said the FDA has an "outdated and burdensome support process that has slowed down the introduction of biosimilars." He said "even erstwhile [the drugs] bash get approved, existent laws often forestall pharmacists oregon patients from substituting them for patients who would payment from a much affordable option."
"That each ends today, a the FDA is taking bold, decisive enactment to interruption down these barriers and unfastened the markets for existent competition," Kennedy said.
Biological products are engineered with surviving cells, which makes manufacturing much analyzable than for chemically derived drugs. Biologics person a peculiar pathway to FDA approval, and it is harder for generic cause manufacturers to merchantability cheaper versions owed to the precocious costs of improvement and hard regulatory landscape.
Biologic medications marque up lone 5% of prescriptions successful the U.S., but relationship for 51% of full cause spending arsenic of 2024, according to an FDA release. FDA-approved biosimilars are arsenic harmless and effectual arsenic their branded counterparts, yet their marketplace stock remains beneath 20%, the bureau added. The FDA said it has truthful acold approved 76 biosimilars, making up lone a tiny fraction of approved biologic drugs.
Kennedy said biosimilars, connected average, outgo fractional the terms of their branded counterparts. Their introduction into the marketplace drives down brand-name cause prices by different 25%, which is simply a "real alleviation for patients," helium added.
Biosimilar generics saved $20 cardinal successful U.S. health-care costs past twelvemonth alone, the FDA said.
In a caller draft guidance, the FDA projected large updates to simplify biosimilar studies. For example, the bureau recommended that quality studies straight comparing the biosimilar to a branded merchandise whitethorn not beryllium indispensable for cause companies to conduct. That probe takes years and costs tens of millions of dollars.
Biosimilars person historically struggled to summation marketplace stock from their branded counterparts compared to generic copies of small-molecule drugs, which are often delivered successful pill signifier and tin participate cells easy due to the fact that it has a debased molecular weight.
The quality is that galore biosimilars aren't identical copies of branded biologic drugs, portion generics are.
In galore cases, pharmacists can't straight substitute a branded biologic for a biosimilar erstwhile filling a medicine unless they are classified arsenic "interchangeable" and it is permitted by authorities law.
But the FDA connected Wednesday said it mostly recommends against requiring alleged "switching studies," which find whether biosimilars person that classification. That measurement is not required for generic copies of small-molecule drugs.
"These further studies tin dilatory improvement and make nationalist disorder astir biosimilar safety," the FDA said successful a release.
English (US) ·