Biosimilar User Fees-FDA Requests Comments But When FDA Plans to Issue Guidance for Biosimilar Pathway Remains Unclear

Biosimilar User Fees-FDA Requests Comments But When FDA Plans to Issue Guidance for Biosimilar Pathway Remains Unclear

May 13th, 2011 // 1:51 pm @

On May 10, FDA published a Federal Register Notice requesting comments on FDA’s proposed development of a user fee program for biosimilar and interchangeable biosimilar biological product applications submitted under Section 351(k) of the Public Health Service Act (“PHS Act”). The biosimilar pathway was added to the PHS Act by the Biologics Price Competition and Innovation Act of 2009 (“Biosimilars Act”). As a general theme, FDA recognizes that at least during the first phase of the biosimilar user fee program (fiscal years 2013-2017), establishing a biosimilar pathway for the first applications likely will be as resource intensive as a full biologics application submitted under Section 351(a) of the PHS Act. As a result, FDA has proposed to charge biosimilar applicants a user fees equal to the Section 351(a) user fees minus any previously-paid fees associated with early product development. The Notice also proposes FDA’s performance goals for the same time period.

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FDA stated that while a number of companies have come to the agency asking for initial guidance regarding the requirements for a biosimilar application, FDA has yet to receive its first biosimilar application. Recognizing that the first and possibly all biosimilar applications will require more resources during the pre-application phase, FDA has proposed ways it can collect a biosimilar application fee earlier in the process. For example, new to biosimilar applications, FDA has proposed a Biosimilar Product Development fee that would be paid once an investigational new drug application (“IND”) is submitted and annually thereafter for as long as the IND is active for a contemplated biosimilar application. Similar to small molecule, new drug applications (“NDAs”), there also will be fees for submitting the biosimilar application and annual establishment and product fees.

According to the Biosimilars Act, FDA must consult with a variety of interests before making its user fee recommendations to Congress on January 15, 2012, including industry, scientific and academic experts, health care professionals, and representatives of patient and consumer groups. Unlike previous user fee programs where there was already a mature industry group, FDA recognizes that it is at this time unclear what will emerge as the biosimilar industry. Based on previous comments to dockets associated with the Biosimilars Act, FDA expects that innovator drug companies and generic drug companies will pursue biosimilar applications, but FDA announced that it will follow a different process than for other user fee programs, given the competing interests and lack of an industry group to expressly represent biosimilar applicant interests.

FDA has requested comments by June 9, 2011, on its proposals for user fees for biosimilar applications. Some of the broad questions included in the Notice include: (1) What factors should the Agency consider in determining appropriate performance goals for 351(k) applications that are filed earlier than 2 years prior to the date on which a 351(k) application would be eligible for approval (i.e., 12 years after the date of first licensure of the reference product); (2) How should the performance goals take into account readiness for inspection; and (3) What other factors relating to the unique characteristics of the 351(k) approval pathway should the Agency consider when setting performance goals for 351(k) applications?

The previous day, May 9, FDA’s Center Director for Drug Evaluation and Research, Janet Woodcock, M.D., reiterated that FDA plans so issue a general guidance for companies that want to submit biosimilar applications under the Biosimilars Act. FDA guidance for what requirements FDA expects for biosimilar applications is not a quid pro quo for FDA’s ability to charge user fees for biosimilar applications, which was a feature built into the Biosimilars Act. While it may be too soon for FDA to act, it has been suggested that it would be prudent for FDA to issue this guidance just prior to the Biotechnology Industry Organization (“BIO”) International Convention on June 27-30, 2011, which would provide a good media opportunity at a widely-attended industry event to announce this highly-anticipated guidance (

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