The FDA is considering a change in biosimilar policy that could make things a lot easier for a whole host of stakeholders that include the companies that develop these complex follow-on biologic drugs, the clinicians who prescribe and dispense these medications, and the patients who receive them.
Right now, when a patient goes to a pharmacy to fill a prescription for a complex biologic, the pharmacist can’t substitute a lower-cost biosimilar unless the FDA has classified that drug as interchangeable with the brand-name product. Interchangeable means the biosimilar can be switched for the reference biologic drug and produce the same clinical result without increasing any safety risks. To secure interchangeability status, a drugmaker must conduct clinical trials. These studies are beyond the clinical tests needed for the biosimilar to secure FDA approval.
The list of drugs that have secured interchangeability status include biosimilars for insulin and the blockbuster AbbVie immunology drug Humira. The clinical trials requirement for interchangeability was established by the Biologics Price Competition and Innovation Act of 2009. Since the law’s passage, the FDA has issued guidance documents that clarify interchangeability requirements. The last guidance came in 2019.
“Since publication of the Interchangeability Guidance, experience has shown that for the products approved as biosimilars to date, the risk in terms of safety or diminished efficacy is insignificant following single or multiple switches between a reference product and a biosimilar product,” the FDA states in new draft guidance posted to the agency’s website on Thursday. “Accordingly, FDA’s scientific approach to when a switching study or studies may be needed to support a demonstration of interchangeability has evolved.”
Under the new draft guidance, a biosimilar developer seeking interchangeability status would not need to conduct an additional set of clinical trials. Instead, the company may provide the FDA with an assessment of why the comparative analytical and clinical data support switching of the product.
The time and expense of switching studies had caught the eye of some lawmakers. Senator Mike Lee, a Utah Republican, has said that these studies contribute to the cost of biosimilars and delay them from reaching patients. Last year, Lee sponsored the “Biosimilar Red Tape Elimination Act,” which proposed eliminating the switching studies requirement. Lee and his co-sponsors said the legislation would put the U.S. on par with the European Medicines Agency, which in 2022 said that biosimilars approved in Europe are considered interchangeable with the reference medication or an equivalent biosimilar. Lee’s bill was referred to the Senate’s Committee on Health, Education, Labor and Pensions, but advanced no further.
The FDA is looking for feedback on its biosimilar guidance update. Comments on the change may be submitted online or by mail until Sept. 20. The docket number is FDA-2017-D-0154.
Public domain photo by the FDA
