By Pooja Babbrah, Senior Consultant In January 2017, the Food and Drug Administration (FDA) released the Final Rule for Biosimilar Naming. In this final rule, the FDA spelled out the …
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 …