FDA Issues Guidance Regarding Interchangeability of Biosimilar and Biologic Drugs
By EsqSocial Corporation 19/01/17
On Tuesday, the U.S. Food and Drug Administration released its latest Guidance for Industry relating to the biosimilar application process set forth in the Biologic Price Competition and Innovation Act of 2009 (BCPCIA). This Guidance, entitled...
By: McDonnell Boehnen Hulbert & Berghoff LLP