The Food and Drug Administration is relaxing regulations on biosimilar drugs used for cancer and rare diseases in the hopes of boosting competition and lowering prices for high-cost pharmaceuticals.
FDA Commissioner Dr. Marty Makary, alongside Health and Human Services Secretary Robert F. Kennedy Jr., announced that the agency would be reducing safety testing requirements and streamlining development guidelines for biosimilar drugs as part of the Trump administration’s overall effort to lower prescription drug prices.
“Under President Trump’s leadership, we are ending this unscientific and corrupt system, we’re cutting through the barriers that protect monopolies and opening the gates to affordable life-saving medicine for the American people,” Kennedy said.
The reform specifically targets biologic drugs, or pharmaceuticals made from living organisms. Biosimilars are medications that are highly similar to an already approved biologic medicine. Although they are not exactly the same as the original drug, also known as the so-called “reference product,” biosimilars have clinically the same effects.
Makary, a physician, sang the praises of biologic drugs for organ transplant patients and cancer patients, which he referred to as the “generic version of the expensive biologics,” but said there needs to be greater competition in the market to put downward pressure on costs.
The FDA commissioner said that his agency published new draft guidance on Wednesday, allowing Phase 3 comparative efficacy studies, possibly reducing the development timelines and cutting costs for biosimilar developers.
Kennedy said that biologics make up only 5% of prescription drugs used in the United States, but they account for more than half of drug spending, doubling from $100 billion in 2013 to $260 billion in 2021.
He also clarified that biologics, also known as large-molecule drugs, have gone through significant safety testing before heading to market, and therefore, biosimilars do not need the same safety studies as long as they are chemically the same.
Makary said that lowered prices for drug developers and lowered research and development costs will mean lower prescription drug prices for American patients.
“This reform will take the five to eight-year time frame to bring a biosimilar to market and cut it in half. It will also save companies about $100 million in their development costs,” said Makary.
The commissioner said that of the biologic drugs on the market with patents expiring in the next 10 years, only 10% have biosimilars currently in development. He said the rate ought to be closer to 30%, and the new streamlined guidance announced on Wednesday will help companies reach that goal.
“We want to see more biosimilars. We want to see more competition, more choices,” Markary said.
Centers for Medicare and Medicaid Services Administrator Dr. Mehmet Oz said during the press conference that one in seven Medicare beneficiaries skips their medications due to high costs.
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Oz called on patients to press their physicians and care teams to prescribe biosimilar drugs that are available if they are clinically the same. He also called for insurance companies to reduce their restrictions on patient access to biosimilars and asked governors to change their Medicaid structures to increase biosimilar access as a way to cut costs without sacrificing care.
“This is a victory for patients, for innovation, and for common sense. We’re replacing bureaucracy with science, we’re replacing monopolies with competition, and we’re replacing despair with hope,” Kennedy said. “Every American, regardless of income or zip code, deserves access to affordable, effective, and safe medicine.”
