FDA creates final guidance on approval pathway for biosimilars
The FDA, as part of the Biosimilars Action Plan, is acting to promote competition in the biologic developer market by providing final guidance for “interchangeable” biologics on the pathway to approval, according to a release from the organization.
The FDA stated that its actions will clarify guidelines for developers who want to prove that their “interchangeable” biologics meet the statutory interchangeability standard under the Public Health Service Act.
“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,” said Norman E. Sharpless, MD, acting commissioner of the FDA in a press release. “Once an application or supplement seeking licensure as an interchangeable product is submitted, the FDA will approve the biological product as interchangeable with the reference product if the information submitted in the application or the supplement is sufficient to meet the applicable statutory standard: among other things, that the biological product is biosimilar to the reference product and can be expected to produce the same clinical result as the reference product in any given patient.”
According to the FDA release, the Biologics Price Competition and Innovation Act of 2009 created an approval pathway for biological products demonstrated to be biosimilar with an FDA-approved reference product.
Designed to improve patient access to lower cost options, upon FDA approval, “interchangeable” biologics could be substituted when prescribed without the involvement of the prescriber.
According to the administration’s statement, the FDA has, to date, licensed 19 “interchangeable” biosimilar products; already strengthening competition in the biologic market. These approvals, in addition to the new final guidance provided in Biosimilars Action Plan, are improving the regulatory foundation for the review and approval of biosimilar products.
In a statement, Angus Worthing, MD, chair of the Government Affairs Committee of the American College of Rheumatology, applauded the announcement, stating the FDA plan will allow it to properly balance biosimilar uptake and provider confidence concerns while prioritizing the safety of our patients.
“Specifically, we are pleased to see that the final guidance expects manufacturers to use robust switching studies,” Worthing said in the statement. “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, multi-state market.”
Worthing added he was also pleased that the FDA had finalized “its approach to safety, immunogenicity, and efficacy for the demonstration of interchangeability.”
“And we agree with the FDA that post-marketing safety monitoring for an interchangeable product should also have robust pharmacovigilance mechanisms in place,” he said in the ACR release. “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. 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.”