Comments on BsUFA Reauthorization

PhRMA Comments for FDA BsUFA III Goals Letter Meeting

BsUFA III will play a critical role in improving the predictable, timely and efficient development and regulatory review of biosimilar and interchangeable biosimilar products. PhRMA fully supports both the proposed BsUFA III performance goals as well as a timely legislative reauthorization of BsUFA. PhRMA looks forward to working with FDA, Congress, patient and medical provider groups and other stakeholders to ensure timely reauthorization of this important program and that there are no disruptions to the FDA activities.

PhRMA Comments for FDA BsUFA III Goals Letter Meeting