White House Announces Action to Increase Competition, Decrease Cost of Biosimilar Development

Updated October 29, 2025, at 3:23 pm

In a US Department of Health and Human Services (HHS) press conference Wednesday, Secretary Robert F. Kennedy (RFK) Jr. announced sweeping actions to accelerate biosimilar development. In turn, introducing a new framework for biosimilar development, which is expected to increase drug manufacturer competition, reduce drug prices, and bolster access to medications.¹

“When Congress wrote the Biologics Price Competition and Innovation Act, the pharmaceutical industry rigged the rules,” RFK Jr. said during the announcement. “Between 2007 and 2009, Big Pharma spent hundreds of millions of dollars lobbying to make biosimilar approval far more difficult and expensive. They claimed that biologics were too delicate, that they were too mystical to allow true generics.”

Filgrastim-sndz (Zarxio) was the very first biosimilar approved by the FDA in March 2015. Zarxio introduced the country to biosimilars, as it was originally developed for the drug filgrastim (Neupogen), which received its FDA approval back in 1991, according to American Health & Drug Benefits.²

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Furthermore, for the much more popular biologic adalimumab (Humira), its first biosimilar was approved back in 2016. However, because of patent litigation and other developmental roadblocks, adalimumab’s first biosimilar was not available for US patients until 2023.³

These long developmental delays for biosimilar creation are what RFK Jr. and HHS are attempting to improve with their recent announcement—along with a decrease in costs for these often-high-cost medications.

“Today, the FDA is taking bold, decisive action to break down these barriers and open the markets for real competition. The agency will release new draft guidance for companies developing biosimilars, guidance that reflects modern science and common sense,” continued RFK Jr. “Under this new framework, companies may not always need to conduct large, expensive human trials when advanced testing can already prove that biosimilars work just as effectively and just as safely as the original drug. The result will be more competition, lower prices, and faster access to life-saving medicines.”

According to the FDA, biologic medications only make up 5% of all prescription drugs dispensed in the US, but these same drugs accounted for 51% of the country’s total drug spend in 2024.⁴ As RFK Jr. and his peers at the press conference stated, they and the FDA believe approved biosimilars are equally safe and effective when compared with branded biologics, yet the former only holds a market share of below 20% for all prescription drugs.^1,4

At the press conference, officials also spoke on their focus toward the interchangeability of these drugs.

“Today, the FDA is also announcing its plans to issue final guidance on interchangeability, something [RFK Jr.] just described, eliminating the bureaucratic switching studies that have been required,” FDA Commissioner Marty Makary, MD, MPH, said.¹ “When a doctor prescribes a branded small molecule, the patient and their pharmacist can have that substituted out for a generic small molecule. But not so with biosimilars. We are taking a strong stand to advance and promote interchangeability.”

Now, with the group’s intended new guidance, biosimilars will be even more focused on establishing accessible and affordable medication options for the patients that need them. Makary added that he and his peers are setting up a long-awaited framework for cutting through the “burdensome, onerous, [and] bureaucratic red tape requirements” posed by the FDA’s biosimilar development and approval process.

Finally, Administrator for the Centers for Medicare & Medicaid Services (CMS) Mehmet Oz, MD, took the podium to further discuss biosimilar pricing and competition, touching on pharmacy benefit managers (PBMs), the newly formed TrumpRx, and what all these new developments mean for US patients and consumers.

“Once [a drug’s] patent [is] over, insurgents should be allowed to enter the marketplace to appropriately compete. That's what the ecosystem of fairness should represent,” said Oz. “That's what's been hindered with this 40-year history of one by one having to break through barriers, with this being one of the largest and perhaps the final major barrier, to ensure that what started with the Hatch-Waxman Act [of 1984] can now reach full fruition and allow the intent of Congress to be heard widely, which is generic products and biosimilars.”

As he stated during the broadcast, the Hatch-Waxman Act was the driving force behind the slow push toward having 91% of all medications dispensed in the US be the more affordable generic option rather than a brand-name drug. With the collection of government leaders at the press conference vying to provide final guidance within the next 3 to 6 months, Oz concluded with his asks for various entities going forward.

“I'm asking patients right now to push for the medications you think make sense for you. I'm asking insurance plans to consider thoughtful design changes to allow low-cost biosimilars to be more accessible to their patients. There have historically been reasons, including the [PBM] rebate model, why that hasn't been allowed or endorsed or supported,” concluded Oz.¹ "The third big ask is to governors. If you can hear my voice now, please listen carefully: Medicaid monies spent on these biosimilars will dramatically reduce the cost that states have to shoulder for Medicaid."

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REFERENCES

1. Kennedy RF, Makary M, Oz M. Accelerating biosimilar development and expanding patient access. US Department of Health and Human Services (Webinar). October 29, 2025. Accessed October 29, 2025. https://www.hhs.gov/live/live-1/index.html#12163

2. Raedler LA. Zarxio (Filgrastim-sndz): First Biosimilar Approved in the United States. Am Health Drug Benefits. 2016 Mar;9(Spec Feature):150-4.

3. Joszt L. First Humira biosimilar, Amjevita, launches in the United States. AJMC. January 31, 2023. Accessed October 29, 2025. https://www.ajmc.com/view/first-humira-biosimilar-amjevita-launches-in-the-united-states

4. FDA moves to accelerate biosimilar development and lower drug costs. News release. FDA. October 29, 2025. Accessed October 29, 2025. https://www.fda.gov/news-events/press-announcements/fda-moves-accelerate-biosimilar-development-and-lower-drug-costs