WASHINGTON (NewsNation) — The FDA, along with Robert F. Kennedy Jr. and Dr. Mehmet Oz, announced the agency will fast-track the approval of biosimilars, or generic versions of complex biological drugs.
In the overhaul of the approval process, Kennedy said the agency will start to reduce the number of human clinical studies for the drugs when other advanced testing has already proved that the drugs work just as well as the regular drug.
“We’re cutting unnecessary red tape, reducing uncertainty and making it easier for innovators to bring the safe, affordable biosimilars to the market,” Kennedy said during a briefing Wednesday.
He added these changes will also ensure that the generic versions are interchangeable, meaning pharmacists can suggest them to patients as the more affordable option.
“We know this approach works,” Kennedy said, noting that biosimilars have saved Americans billions of dollars when getting the necessary prescriptions. According to the Association for Accessible Medicines, savings from biosimilar medications saved people more than $20 billion in 2024.
The FDA has said biological drugs are the fastest-growing class of medications in the United States and account for a substantial and growing portion of health care costs.
In May, President Donald Trump signed an executive order aimed at lowering the cost of prescription drugs by implementing a “most favored nation” policy that caps the prices Americans pay based on those charged in other countries.
Trump has repeatedly criticized the current system as “unfair,” insisting he wants Americans to “stop being ripped off.” He warned drug makers that penalties could be in store if they did not work to cut costs.
The Trump administration has since struck deals with both Pfizer and AstraZeneca to offer discounts on prescription drug costs. AstraZeneca pledged to list many of its most popular drugs on TrumpRx, a new website allowing users to buy medications directly from manufacturers.