After finalizing three key guidance documents on biosimilars at the end of April (reported on our blog here), yesterday FDA released another “Question and Answer” guidance in draft form. The draft guidance is called “Biosimilars: Additional Questions and Answers Regarding Implementation of the Biologics Price Competition and Innovation Act of 2009.” It includes the questions that were omitted from the finalized Q&A document and also several new questions and answers. For example, two of the new questions address pediatric research requirements and how a sponsor should initiate discussion on pediatric study plans with FDA. Another question deals with a technical issue regarding what dosage form of a proposed biosimilar would be considered the “same” dosage form as the reference product; and another offers details regarding how a non-U.S.-licensed product may be imported and used in a clinical study by a potential biosimilar applicant.
FDA is seeking stakeholder input on the Agency’s proposed responses to the revised and new questions, and it requests that interested parties submit their comments no later than July 13 to ensure that they are considered by the Agency as it begins work to finalize the document. Notably, FDA has been criticized for the length of time it has taken to provide substantive guidance to potential sponsors of biosimilar applications, most recently in an open letter from a group of GOP Senators who called the FDA’s work so far to implement the BPCIA “opaque.” The Senate letter also requested specific detailed information from the Agency on numerous issues. We expect additional draft guidances on important biosimilar topics (such as the policy for nonproprietary naming) from FDA over the remaining months of 2015, and it will be interesting to see whether and how critics of the Agency’s BPCIA implementation efforts respond to any new actions taken by FDA.