FDA Looking at Time it Takes to Prepare a Biosimilar Application

Long-awaited guidance on designating a biosimilar as interchangeable with the reference product may soon be in the offing, based on an FDA request for comments on a proposed collection of information.

Specifically, the FDA wants drugmakers’ feedback on its estimate that a biosimilar or interchangeable application will take as much time to prepare as the reference biologic’s filing — about 860 hours. The agency wants to know if the required information is necessary, ways to enhance the quality of the information collected and if there are ways to make the collection easier for companies to handle.

The filings have the same estimated length of preparation time as reference biologics because they are expected to be comparably complex and technically demanding, the FDA says.

So far the agency has only issued guidance on demonstrating biosimilarity, rather than the greater regulatory onus of interchangeability. Interchangeability is one of four biosimilars topics the FDA said it was looking to publish guidance on this year.

While biosimilar applications need to show “no clinically meaningful differences” from the reference therapy, interchangeables win their status by convincing the FDA they will have the same clinical result as the reference in any given patient. Sponsors would also have to show that the risk of multiple doses after a switch would be the same as the risk of multiple doses of the reference if swapping didn’t occur.

The 2010 law creating the biosimilar approval pathway allows for interchangeable-designated therapies to be switched from the reference without the prescriber’s approval, although substitution is determined state to state.

Filers can submit their request for an interchangeable designation in their initial biosimilar application or in a later supplement, the FDA says.

The FDA anticipates receiving about five biosimilar applications per year based on current trends. Last month, Hospira became the fourth drugmaker to publicly announce a U.S. biosimilar application. The first was announced last summer.

Comments on the proposed collection are due April 6. See the Federal Register notice at www.fdanews.com/02-06-15-BiosimilarApplications.pdf. — Bryan Koenig