Biosimilars Naming Conventions On FTC Agenda – In More Ways Than One
This article was originally published in RPM Report
Executive Summary
An planned Federal Trade Commission hearing on biosimilar competition will include discussion of the debate over the right approach to non-proprietary names. But FTC may be reopening another naming debate by referring to the hearing topic as “follow-on biologics.”
You may also be interested in...
Pragmatic Oncology Trials: Survival Is Only Viable Endpoint For Now; FDA Emphasizes Streamlining
Overall survival is the only viable endpoint for pragmatic trials in oncology, the US FDA and a panel of stakeholders agree, although other novel endpoints could be validated over time. In the meantime, FDA says, sponsors should focus on other aspects of trials that can be streamlined.
The Future Of US FDA’s Institutional Memory
Upcoming retirement of Janet Woodcock will mean loss of one of agency's FDA’s most experienced and influential drug regulators. However, CDER still has plenty of long-tenured staff peppered across all its key functions.
The Future Of US FDA’s Institutional Memory
The upcoming retirement of Janet Woodcock will mean the loss of one of the US FDA’s most experienced and influential drug regulators. However, the drug center still has plenty of long-tenured staff peppered across all of its key functions.