On April 28, 2015, FDA released three final versions of guidance documents relating to biosimilars that were initially released in February 2012. One of the guidances provided Questions and Answers regarding implementation of the Biologics Price Competition and Innovation Act (BPCIA). The final version of the Q & A document noticeably did not contain several questions present in the earlier draft of 2012. The reason for the deletion was speculated to be tied to FDA reconsidering their earlier assessments to these questions. The draft guidance released on May 12, 2015 – Biosimilars: Additional Questions and Answers Regarding Implementation of the Biologics Price Competition and Innovation Act of 2009 [add hyperlink] – clarifies FDA’s position on those deleted questions. Specifically, the Q & As are grouped in the following categories: (1) biosimilarity or interchangeability; (2) Provisions Related to Requirement to Submit a BLA for a “Biological Product;” and (3) Exclusivity. It is important to note that while some of the Q & A addresses interchangeability, the new draft guidance is not the long-awaited interchangeability guidance that is due to be released.

Perhaps the answer to the question most eagerly awaited was whether an applicant can obtain a determination of interchangeability in an original 351(k) application – to which the FDA answered Yes. However, FDA added the caveat that, at this time, it would be difficult as a scientific matter for a prospective biosimilar applicant to establish interchangeability in an original application given the statutory standard for interchangeability and the sequential nature of that assessment. Thus, FDA left the specifics regarding the particulars for demonstrating interchangeability to another day...