FDA to Speed Biosimilar Approvals in Push to Cut Drug Costs (1)

The FDA is planning to speed approvals of highly similar copies of expensive biologic drugs, the latest effort in President Donald Trump’s aggressive agenda to lower costs for medicines in the US.

“We need to cut the red tape for biosimilars, and we need to recognize that biosimilars have the promise of lowering drug prices—a major priority in this administration,” Marty Makary, commissioner of the Food and Drug Administration, said Wednesday at a conference focused on generics and biosimilars.

“We’re also going to improve our reviews and process times,” Makary said. “If a biosimilar is going to be made in the United States of America, it’s going to go to the front of the line.”

The remarks came ahead of the formal announcement later Wednesday on accelerating biosimilar development. Draft guidance was released by the agency Wednesday morning that proposes a significant update to eliminate a requirement in biosimilar applications.

The Trump administration has pressured pharmaceutical giants to lower US drug prices through various demands, including tying costs to international prices and providing medicines to patients through direct-to-consumer platforms. Pfizer Inc., AstraZeneca PLC, and Merck KGaA have locked in deals with Trump, promising to sell existing medicines to Medicaid patients at steeply discounted prices, though the commitments so far have scant details about implementation and impact on consumer savings.

Biosimilars are highly similar copies of FDA-approved biological drugs that have no clinically meaningful difference and can treat patients the same way. The FDA has approved 76 biosimilars, with the latest this month of Celltrion’s Eydenzelt, a biosimilar to Regeneron’s Eylea to treat several eye conditions.

The products are often available at a lower cost than the original.

The Association for Accessible Medicines, an industry group representing generics and biosimilars, reported that FDA-approved generic and biosimilar medicines created $467 billion in savings in 2024 for patients. The products generated $3.4 trillion in savings in the last 10 years, the group also found.

But while the FDA has approved various biosimilars, not all are marketed and available to US patients immediately, often due to patent litigation or agreements to defer entry into the market.

This has spurred debates on whether several alternatives of an original biological drug, such as to AbbVie Inc.’s inflammatory treatment Humira, can bring down the actual cost for expensive biologics. Reports also indicate that price reductions and savings have been limited for biosimilars that have entered the market.

“Once a biosimilar comes to market, I do ask that you lower the price significantly beyond the biologic price,” Makary told the industry Wednesday.

“Sometimes, when there’s one or two biologics on the market, we don’t see the prices come down that much,” he said. “There’s sometimes an implied price collusion that goes on, and we want to see lower drug prices for everyday Americans.”

US Health Secretary Robert F. Kennedy Jr. said at a press conference Wednesday that the biosimilar market “still lags far behind Europe’s,” costing Americans “hundreds of millions.”

TrumpRx, a direct purchasing platform planned for next year to allow patients to purchase some medicines at a reduced cash price, will publish prices of all drugs and their generics and biosimilar competitors, said Mehmet Oz, administrator for the Centers for Medicare & Medicaid Services.

“Individuals can make the right choice for them and will have options,” Oz said.

Removing a Hurdle

The draft guidance published Wednesday proposes to eliminate a requirement for biosimilar makers’ applications to the FDA.

A comparative clinical study or studies with efficacy endpoints that are used to support a demonstration of biosimilarity may not be necessary, according to the new guidance.

The proposal updates final draft guidance issued by the agency in April 2015 on why studies are necessary to support a biosimilar application.

“It takes like four to six years for a biosimilar to get developed, and then you add the FDA review time of five to eight years for a biosimilar to come to market. Why?” Makary said. “Hopefully that will shave off a couple years—three or four years—from the process.”

The industry can expect a final guidance in the next three to six months, Makary said later at a press conference.

The commissioner also told the industry he firmly believes in advancing interchangeability of biosimilars—the process in which the product can be swapped out as a substitute for a biologic at the pharmacy counter without a doctor’s prior approval.

The agency plans to finalize guidance introduced last year that eliminates a “switching study,” or studies intended to support that a biological product is interchangeable with an FDA-licensed biological reference product.

Industry Applauds

The announcement has so far received praise from the biosimilar industry, especially after leaders touted earlier this year that 2025 would be an active year for them.

“We’re finally breaking through,” John Murphy III, president and CEO of AAM, said during a fireside chat with Makary. “We have an administration and an FDA commissioner that really understand that this is the path forward.”

The Biosimilars Forum said the administration “rightfully recognizes the importance of developing biosimilars efficiently based on science—rather than being slowed down by bureaucracy.”

“While biosimilars have already saved the U.S. healthcare system $56 billion, there is the potential for so much more cost-savings,” Juliana M. Reed, executive director of the Biosimilars Forum, said in a statement.