A statement by the Food and Drug Administration (FDA) departing commissioner, Scott Gottlieb, reinforced a key aspect of biosimilar naming and provided important updates to the use of four-digit suffixes for biologics and biosimilars. In his statement, Dr. Gottlieb said, “In January 2017, the FDA published a guidance document in which we sought to … Continue reading FDA’s Gottlieb Announces Important Changes to Biosimilar and Biologic Naming
Tag: nomenclature
An Update From BBCIC: A Conversation With Cate Lockhart, Program Director—Part 2
The Biologics and Biosimilars Collective Intelligence Consortium (BBCIC) is the organization that will perform the critical task of postmarketing surveillance for biosimilars and their reference biologics. Started in 2015, the BBCIC is a nonprofit, scientific public service initiative, which partners with multiple stakeholders to accomplish its mission. In the conclusion of our two-part interview with Cate … Continue reading An Update From BBCIC: A Conversation With Cate Lockhart, Program Director—Part 2