FDA to hurry up generic drug approvals as Trump targets drug costs

The Food and Drug Administration on Wednesday said it can take steps to hurry up the method of developing generic versions of complex biological drugs, in a bid to extend cheaper competition for expensive medicines and lower drug costs for Americans. 

It is the Trump administration’s latest move to rein in high prescription drug costs within the U.S., where medication prices are two-to-three times higher than those in other developed nations. 

The move to support the event and approval of so-called biosimilars could possibly be a blow to pharmaceutical firms, whose most profitable products are sometimes biological products that treat serious and chronic diseases. The precise impact will depend upon the drugmaker and its products.

In an announcement on Wednesday, a Health and Human Services Department spokesperson said the law gives manufacturers 12 years of exclusivity for biologic medicines, which is a “primary determining consider drug development decision-making.”

“No manufacturer should anticipate a monopoly or anything beyond what’s legally granted,” the spokesperson said.

The FDA’s latest reforms “will take the five-to-eight 12 months timeframe to bring a biosimilar to market and cut it in half,” the agency’s Commissioner Marty Makary said during a press conference on Wednesday.

Throughout the event, HHS Secretary Robert F. Kennedy Jr. said the FDA has an “outdated and burdensome approval process that has slowed down the entry of biosimilars.” He said “even when [the drugs] do get approved, current laws often prevent pharmacists or patients from substituting them for patients who would profit from a more cost-effective option.”

“That every one ends today, a the FDA is taking daring, decisive motion to interrupt down these barriers and open the markets for real competition,” Kennedy said.

Biological products are engineered with living cells, which makes manufacturing more complex than for chemically derived drugs. Biologics have a special pathway to FDA approval, and it’s harder for generic drug manufacturers to sell cheaper versions resulting from the high costs of development and difficult regulatory landscape. 

Biologic medications make up only 5% of prescriptions within the U.S., but account for 51% of total drug spending as of 2024, in keeping with an FDA release. FDA-approved biosimilars are as secure and effective as their branded counterparts, yet their market share stays below 20%, the agency added. The FDA said it has up to now approved 76 biosimilars, making up only a small fraction of approved biologic drugs.

Kennedy said biosimilars, on average, cost half the value of their branded counterparts. Their entry into the market drives down brand-name drug prices by one other 25%, which is a “real relief for patients,” he added. 

Biosimilar generics saved $20 billion in U.S. health-care costs last 12 months alone, the FDA said.

In a brand new draft guidance, the FDA proposed major updates to simplify biosimilar studies. For instance, the agency beneficial that human studies directly comparing the biosimilar to a branded product is probably not essential for drug firms to conduct. That research takes years and costs tens of thousands and thousands of dollars. 

Biosimilars have historically struggled to achieve market share from their branded counterparts in comparison with generic copies of small-molecule drugs, which are sometimes delivered in pill form and might enter cells easily since it has a low molecular weight.

The difference is that many biosimilars aren’t an identical copies of branded biologic drugs, while generics are. 

In lots of cases, pharmacists cannot directly substitute a branded biologic for a biosimilar when filling a prescription unless they’re classified as “interchangeable” and it’s permitted by state law. 

However the FDA on Wednesday said it generally recommends against requiring so-called “switching studies,” which determine whether biosimilars have that classification. That step is just not required for generic copies of small-molecule drugs. 

“These additional studies can slow development and create public confusion about biosimilar safety,” the FDA said in a release.