Tag: Biologics

Pooja Babbrah

How Stakeholders are Affected by FDA’s New Naming Convention for Biologics and Biosimilars

By Pooja Babbrah, Senior Consultant Stakeholders across the industry are debating potential costs and burden associated with implementing the new, nonproprietary naming convention for biologics and biosimilars. Requirements for the …

Pooja Babbrah

FDA Issues Guidance on Naming Conventions and Interchangeability for Biologics and Biosimilars

By Pooja Babbrah, Senior Consultant The Food and Drug Administration (FDA) recently issued two new rules that significantly affect biologics and biosimilars.  The first rule spells out the naming conventions …