News from the FDA/CDC

FDA issues final guidance on seeking licensure for interchangeable biologics


Final guidance on the pathway for developers seeking licensure for “interchangeable” biologics was issued on May 10 by the Food and Drug Administration.

Dr. Norman E. "Ned" Sharpless, director of the National Cancer Institute Courtesy University of North Carolina

Dr. Norman E. Sharpless

The action provides “clarity for developers who want to demonstrate that their proposed biological product meets the statutory interchangeability standard under the Public Health Service Act,” Norman E. Sharpless, MD, the acting commissioner of the agency, said in a press release.

Biologics deemed “interchangeable” will be able to be substituted without the involvement of the prescriber, similar to how generic drugs are now routinely substituted for brand name drugs. On March 23, 2020, the FDA will be able to license such interchangeable products.

On May 13, the agency will consider what factors need to be weighed when determining whether an insulin product is biosimilar to or interchangeable with a reference product at a public hearing: “The Future of Insulin Biosimilars: Increasing Access and Facilitating the Efficient Development of Biosimilar and Interchangeable Insulin Products.”

“We also expect to hear stakeholder feedback on whether certain insulin products – for example, those that use insulin pumps for continuous subcutaneous infusion among the approved uses – raise unique scientific considerations that we should be considering when evaluating biosimilar or interchangeable insulin products. And importantly, we’ll also be seeking input directly from patients about their experience with insulin products, and this input will inform the FDA’s approach to implementing the regulatory pathway for biosimilar and interchangeable insulin products,” Dr. Sharpless said in the statement.

The ability to substitute an interchangeable insulin product – or any chronically used biologic medication – at the pharmacy could potentially increase access and lower costs for patients.

Dr. Sharpless added that the FDA has developed and is working to implement a Biosimilars Action Plan that includes a suite of ongoing efforts to encourage innovation and competition among biologics and the development of biosimilars.

The 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. The guidance also explains potential ways to address the Biologics Price Competition and Innovation Act requirement for interchangeability that, for a biological product that is administered more than once to an individual, the risk in terms of safety or diminished efficacy of alternating or switching between use of the biological product and the reference product will not be greater than the risk of using the reference product without alternating or switching.

“Our rigorous scientific standards for approval will be maintained for interchangeable biologics and should serve as assurance to health care professionals and patients that they can be confident in the safety and effectiveness of both interchangeable products and biosimilar products, just as they would be for reference products,” Dr. Sharpless said in the statement.

Medical specialty organizations have begun to weigh in on the FDA final guidance, “Considerations in Demonstrating Interchangeability with a Reference Product.”

The American College of Rheumatology applauded the FDA action.

“Specifically, we are pleased to see that the final guidance expects manufacturers to use robust switching studies. At least three switches with each switch crossing over to the alternate product will be needed to determine whether alternating between a biosimilar and its reference product impacts the safety or efficacy of the drug. The ACR believes these studies will provide an understanding of what patients are likely to experience when changing formularies in a multipayer, multistate market,” Dr. Angus Worthing, chair of the American College of Rheumatology’s Government Affairs Committee, said in a statement.

“We are also pleased to see the FDA finalize its approach to safety, immunogenicity, and efficacy for the demonstration of interchangeability. And we agree with the FDA that postmarketing safety monitoring for an interchangeable product should also have robust pharmacovigilance mechanisms in place. In order to improve clarity, the ACR suggests that FDA prescribing information for all biosimilars include statements about whether each agent is or is not interchangeable to the reference product,” he said. “The ACR shares the FDA’s goal of ensuring that more affordable treatments reach patients as quickly as possible and appreciates the agency’s measured and thoughtful approach throughout this process.”

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