A group of senators called for the Obama administration to clarify the FDA’s policy on the approval of biological products that are deemed interchangeable with previously licensed products.
Sens. Lamar Alexander (R-Tenn.), Richard Burr (R-N.C.), Orrin Hatch (R-Utah) and Pat Roberts (R-Kan.) were among the senators who called for guidance on “biosimilar” products in a letter to Health and Human Services Secretary Sylvia Burwell, according to a press release.
The Biologics Price Competition and Innovation Act, which was approved in 2010, established a framework for FDA approval of biosimilar medications.
The FDA recently received its first biosimilar application, but it has not answered questions related to the naming, labeling, indication extrapolation and interchangeability of biosimilars.
“The public needs to have time to comment, and FDA (needs) time to revise the policies set forth in this draft guidance, if necessary,” the senators said. “It is our understanding that FDA has forwarded the naming guidance to the Department of Health and Human Services, and this guidance is awaiting HHS’s clearance so it can be released for stakeholder comment.”
The senators said there are differences of opinion related to the issues of naming products and demonstrating interchangeability, so a draft proposal should be released as soon as possible.
“In order to ensure the success of the biosimilar pathway, it is imperative that the scientific experts at FDA maintain the autonomy to implement the pathway as intended in a manner that puts the safety of patients first,” the senators said.