The Food and Drug Administration on Friday gave clear suggestions for drugmakers to make it easier for patients to obtain biosimilars, treating them similarly to generic drugs.
In the final guidance, FDA gave drugmakers some clarity on the studies they need to show their biosimilar is interchangeable with a biologic. While federal law created a pathway for interchangeability, drug companies have been seeking greater guidance from the agency. Healthcare providers have called on the Trump administration and Congress to do more to increase availability of biosimilars. Biologics can cost hundreds of thousands of dollars for chronic conditions.
"Today's final guidance gives an overview of important scientific considerations in demonstrating interchangeability with a reference product and explains the scientific recommendations for an application or a supplement for a proposed interchangeable product," acting FDA Commissioner Ned Sharpless said in a statement.
The FDA has approved 19 biosimilar drugs, but it has not approved any drugs that are interchangeable with a biologic. Several providers say that the lack of interchangeability has been one of the barriers to more availability with others being physician reluctance.
Catholic hospital chain Ascension recently complained at a U.S. House of Representatives hearing that physicians are reluctant to prescribe biosimilars and interchangeability is gravely needed.
The guidance will be very helpful for healthcare systems that include pharmacies.
"It is easier if you are in the hospital to page the doctor and call the doctor," said Steven Lucio, vice president of pharmacy solutions at the group purchasing organization Vizient. "It is more difficult if you are dealing with a physician that isn't affiliated with you and in the pharmacy."
Lucio added that another major hurdle for biosimilar uptake is confusion among payers.
"The payer community is also trying to drive biosimilars, but they may not always be trying to drive the same biosimilar," he said. "The big challenge has been a lack of alignment between what the health system wants to do and what the payer has decided."
Currently only one company, Boehringer Ingelheim, is pursuing FDA approval for an interchangeable biosimilar designation. Boehringer is pursuing an interchangeable biosimilar of the blockbuster and expensive arthritis drug Humira, one of the top-selling drugs in the world.
The guidance is part of a larger action plan by the FDA to spread biosimilar use. The agency is holding a meeting on Monday to learn about challenges with insulin biosimilars.