Business · 20/09/2021
FDA Releases Revised Guidance on Biosimilar Development and BPCI Act
The FDA has released a revised final guidance document to inform prospective applicants about biosimilar development and the Biologics Price Competition and Innovation Act of 2009, aiming to facilitate the development of proposed biosimilars and interchangeable biosimilars.
Original source language: Federal Register — Food and Drug AdministrationOpen original release →