FDA to Issue Draft Guidance on Interchangeability by End of Year

gloved hand withdraws drug solution with syringe

Last Thursday, October 20, the FDA held a scheduled public meeting on the reauthorization of the Biosimilar User Fee Act (BsUFA).  The FDA heard from a wide spectrum of stakeholders, including patient/public health advocates, healthcare professionals, and industry representatives.  As we previously reported, the FDA had committed to publishing a draft guidance on biosimilar interchangeability by the end of 2017 and a final guidance two years after the close of public comments.  Politico reports that the groups at the meeting pushed the FDA to finalize guidances on key biosimilar policies ahead of the deadlines specified in the user fee agreement.

The FDA has since confirmed that it will issue draft guidelines on biosimilar interchangeability by December 2016, one year earlier than the original deadline of December 2017.

Stay tuned to Big Molecule Watch for more updates.