Trump administration officials pledged Monday that major reforms for biosimilar drug approvals will expand access and lower prices for some of the most expensive drugs on the market.
Food and Drug Administration Commissioner Marty Makary and Centers for Medicare and Medicaid Services Administrator Mehmet Oz outlined further details about the Trump administration’s plan to slash regulations on biosimilar drug development in an op-ed on Monday.
The administration’s reforms specifically target biologic drugs, or pharmaceuticals made from living organisms, that are frequently used to treat cancers, autoimmune conditions, and rare diseases. Biosimilars are, in essence, generic versions of biologic drugs, also referred to as large-molecule drugs.
Health and Human Services Secretary Robert F. Kennedy Jr., alongside Makary and Oz, announced last week that the FDA would slash red tape that has made biosimilar drug development significantly slower than that of other pharmaceuticals, keeping their prices high because of limited competition.
Makary and Oz wrote in their Fox News op-ed that hurdles for drug manufacturers seeking to produce biosimilars were “originally set up by Congress, but the FDA has historically gone a step further by taking an overly cautious approach.”
Until last week, the FDA has required biosimilar developers to conduct comparative clinical trial studies before granting approval, which is not required for generics in the small molecule drug class.
“When a doctor prescribes an expensive biologic, substitution with a biosimilar has not been routine, as it is for every other branded drug and their generic equivalent,” Makary and Oz wrote. “This perverse system has been fueled by pharmaceutical companies, pharmacy benefit managers and reimbursement policies that incentivize doctors to use more expensive medications.”
Oz and Makary wrote that biologics account for 51% of drug spending in the United States, but only 10% of the biologics set to lose patent protections in the next decade have biosimilars in development.
Trump administration officials said last week during the official announcement of the policy that biosimilar drug spending in the U.S. more than doubled from $100 billion in 2013 to $260 billion in 2021.
Oz and Makary said that eliminating extra clinical trial steps will slash the development time for biosimilars, increasing competition in the market that will, in turn, lower prices.
The Trump administration officials said their reforms would “save billions for the Medicare program” and help solve one aspect of the “affordability crisis that has plagued all insurance programs.”
The duo emphasized that the FDA is working hand-in-hand with the CMS to increase insurance approvals and reimbursement for biosimilars within the Medicare and Medicaid programs.
The biosimilar reform comes as the Trump administration has also been advancing the “most favored nation” prescription drug policy, negotiating with pharmaceutical companies to lower drug prices by increasing the list prices for drugs in other countries.
President Donald Trump announced two “most favored nation” deals from the White House last month, one with Pfizer and one with AstraZeneca.
He also announced the development of the new TrumpRx platform, on which patients will be able to connect directly with drug manufacturers for the new, lower “most favored nation” prices.
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Oz and Makary wrote in their op-ed that Trump “demands that our nation’s regulatory process protect innovation by incentivizing the best solutions at an affordable price for our people.”
“We are choosing to enact meaningful reforms now that will bring a generation of fair prices to healthcare,” Makary and Oz wrote.
