Timing is Everything: Biotech Pioneers Push Follow-On Biologics Proposal
This article was originally published in RPM Report
Executive Summary
Once unthinkable, the pioneer biotech firms are jumping in with their own proposals for an abbreviated follow-on biologics regulatory pathway. They recognize that this may be the best time for many years to get a system that builds in rigorous tests for follow-ons.
You may also be interested in...
Flubbing the FOBs Opportunity: Follow-on Biologics Winners & Losers
An abbreviated pathway for follow-on biologics just missed getting tacked onto the FDA user fee/drug reform legislation. It will be years before proponents get another shot at creating an abbreviated approval pathway for the biotech copycats. So who won and who lost?
Flubbing the FOBs Opportunity: Follow-on Biologics Winners & Losers
An abbreviated pathway for follow-on biologics just missed getting tacked onto the FDA user fee/drug reform legislation. It will be years before proponents get another shot at creating an abbreviated approval pathway for the biotech copycats. So who won and who lost?
Novo Nordisk: Riding High on Diabetes
Novo Nordisk is confident that it can continue to generate strong growth from its leading diabetes franchise. Having exited oral anti-diabetics, it's betting on further innovation in insulin and on a strong entry into the GLP-1 analog space.