Biosimilars Conference

FDA and industry have recently negotiated a series of enhancements to the Biosimilars User Fee Act (BsUFA II). These include a revised review process meant to increase transparency and to facilitate an increase in the likelihood of first-cycle approvals; FDA commitments to complete and publish several draft and final guidance documents; FDA commitments to strengthen staffing levels of the biosimilars program; and enhancements to the user fee structure and management that will allow greater transparency, predictability, and long-term stability of biosimilar development programs in the US. This session will review these enhancements and the impact they are intended to have on the development and approval of biosimilars in the US.