DR. MAKARY, DR OZ: People talk about lowering healthcare costs, but the Trump administration is doing it

FDA announces major biosimilar reforms to cut drug costs, removing extra clinical trial requirements that delay cheaper alternatives to $200,000 biologics by years.

Currently, it takes six to eight years for a biosimilar to come to market, a delay that allows biologic drugmakers to keep charging high prices for years. Marty Makary, M.D., M.P.H. is the commissioner of the Food and Drug Administration.   

Ever since the first approval of a biosimilar in 2015, it has been difficult for patients to access them. 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. This perverse system has been fueled by pharmaceutical companies, pharmacy benefit managers and reimbursement policies that incentivize doctors to use more expensive medications.

Now the FDA is taking a strong position to make it easier to substitute biosimilars with expensive biologics. We are also announcing a radical streamlining for biosimilars and a new policy to dramatically reduce the time and cost to bring these lower-cost biosimilars to market.