On February 3, 2015, FDA published a notice in the Federal Register requesting comments on information collection in an application for a proposed biosimilar and a supplement for a proposed interchangeable product. Federal agencies must obtain approval from the Office of Management Budget for collection of information that they conduct of sponsor, along with providing such notice in the Federal Register and providing 60-days for comment. Accordingly, the comment period for this notice expires April 6, 2015.
Specifically, FDA requested comments on the topics:
(1) Whether the proposed collection of information is necessary for the proper performance of FDA’s functions, including whether the information will have practical utility; (2) the accuracy of FDA’s estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; (3) ways to enhance the quality, utility, and clarity of the information to be collected; and (4) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques, when appropriate, and other forms of information technology.
The Notice then provides the general licensing provisions for biosimilar applications under Section 351(k) of the Public Health Service Act and compared the estimated collection burden for applicants comparing full biologics license applications (BLAs, or 351(a) applications under the Public Health Service Act) to 351(k) applications as a “biosimilar” and under 351(k) as an “interchangeable biosimilar”. In all instances, the magic number is an average 860 hours. Why?
Until we gain more experience with biosimilar applications, FDA believes this estimate is appropriate for 351(k) applications because to determine biosimilarity or interchangeability of a proposed 351(k) product, the application and the information submitted is expected to be comparably complex and technically demanding as a proposed 351(a) application. FDA may determine, in its discretion, an element required under a 351(k) application to be unnecessary to support licensure of a biosimilar or interchangeable product. In those cases, the number of hours per response may be less than the hours estimated.
As an interesting corollary, the estimated table indicates that FDA received five 351(k) biosimilar applications and two interchangeable 351(k) applications or supplements. At this point, there are only three 351(k) applications accepted for filing and one pending that have been announced, so what happened to the other ones and which ones have been submitted with a request for interchangeability? Stay tuned!