RFK Jr. Seeks To Accelerate Approvals for Lower-Cost Generic Alternatives to Expensive Biologic Drugs

Health Secretary Robert F. Kennedy Jr. says he wants to slash the time and cost of approving generic versions of hugely expensive biologic drugs that are driving accelerating health care costs.Biologics are a class of prescription drugs derived from living organisms — such as bacteria or human cells — that treat serious and chronic diseases. Biologic medications make up only 5 percent of prescriptions in America but accounted for more than half of total drug spending in 2024, according to the Department of Health and Human Services.Noting that some biologics cost patients $500,000 a year or more, Mr. Kennedy said, “That’s not a health care system, it’s a hostage crisis.”Even insured patients face substantial out-of-pocket costs for biologics. Medicare and Medicaid also face surging costs from expensive biologics, according to health officials.Biosimilar medicines are lower-cost generic alternatives to those drugs. At a press conference on Wednesday, Mr. Kennedy said the Food and Drug Administration is proposing to simplify the approval process and reduce “unnecessary clinical testing” to get biosimilars to market faster. The commissioner of the Food and Drug Administration, Dr. Martin Makary, says the proposal would cut the 5- to 8-year approval process and costs in half.“By streamlining the biosimilar development process and helping advance interchangeability, we can achieve massive cost reductions for advanced treatments for cancer, autoimmune diseases, and rare disorders affecting millions of Americans,” Dr. Makary said.There are currently only 76 biosimilars approved and their market share is below 20 percent. Some of the biosimilars treat conditions such as cancer, rheumatoid arthritis, diabetes, Crohn’s disease, and osteoporosis.Only about 10 percent of biologic drugs expected to lose patent protection in the next decade currently have a biosimilar in development. The Trump administration is hoping to encourage more development with the easier approval process.Mr. Kennedy says the number of approved biosimilars could quickly more than double if the burdensome approval process is simplified.“For too long, a burdensome approval process has kept patients from accessing more affordable biosimilars,” Mr. Kennedy said. “This bold action by the FDA accelerates biosimilar development, drives market competition, expands patient options, and advances our mission to Make America Healthy Again.”The agency, through a separate initiative, also plans to make it easier for biosimilars to be developed as interchangeable with brand-name biologics, helping patients and pharmacists choose lower-cost options more easily.

RFK Jr. Seeks To Accelerate Approvals for Lower-Cost Generic Alternatives to Expensive Biologic Drugs

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