Health officials announced on Oct. 29 that they are proposing the elimination of testing requirements for biosimilars, or generic versions of biologic drugs.
If a comparative analytical assessment shows that a biosimilar is similar to a biologic, then a comparative efficacy study “may not be necessary,” the guidance states.
Health Secretary Robert F. Kennedy Jr., whose Department of Health and Human Services includes the FDA, said at a news conference in Washington, “We’re cutting unnecessary red tape, reducing uncertainty, and making it easier for innovators to bring safe, affordable biosimilars to the market.”
Biologics include medications for cancer and autoimmune disorders. They make up 5 percent of the prescriptions in the United States, but as of 2024 accounted for 51 percent of drug spending, the FDA stated. Some of the spending came from the government-funded Medicare and Medicaid programs.
Biosimilars typically cost less than similar biologic drugs and help drive down the cost of the biologics, according to officials.
Under existing regulations, which Kennedy and FDA Commissioner Dr. Marty Makary said were outdated and too cumbersome, it takes five to eight years to bring biosimilars to market.
The updated guidance will cut that time in half and save companies $100 million in costs, Makary said, citing discussions with unspecified companies.
“Lowered prices for drug development means lower R&D costs and lower prices for everyday Americans,” he said at the news conference.
Congress laid out the approval pathway for biosimilars in a 2010 law called the Biologics Price Competition and Innovation Act.
Makary said the FDA should have approved 200 or 300 biosimilars by now.
Alex Schriver, senior vice president of public affairs at the Pharmaceutical Research and Manufacturers of America, told The Epoch Times in an email, “We welcome the administration’s focus on increasing biosimilar access and affordability.”
The trade group represents drug manufacturers such as Bristol Myers Squibb and Pfizer.
Schriver said the group believes that the real problem is pharmacy benefit managers excluding lower-cost generic drugs and biosimilars from coverage.
“Policymakers must fix the misaligned incentives and business practices by middlemen who block biosimilars and profit off medicines at the expense of patients,” he said.
For most biosimilars, the FDA is also removing the recommendation that they be tested in switching studies, which entails testing the biosimilars against brand-name biologics.
That will enable pharmacists to help patients choose the more affordable option, officials said. Pharmacists can currently substitute generic drugs for brand-name drugs.
