Naming Rights: Biosimilar Influence Efforts Continue Before Products Take The Field
FDA isn’t immune to political pressure, but a group of senators arguing that biosimilars should be given the same International Nonproprietary Name as their branded counterparts will need to make a stronger case than citing the agency’s own previous analysis.
You may also be interested in...
Biosimilars: FDA, EMA Developing Common Data Package Guidance
Guidance is “emerging” that will allow sponsors to use data from products not licensed in their respective regions in applications.
Track-And-Trace Insufficient For Biosimilar Pharmacovigilance, Brand Companies Say
A Johnson & Johnson citizen petition lays out the company’s case for individual non-proprietary names for biologics and each of their biosimilars, citing the risk of inappropriate substitution.
Is FDA Reviewing A Biosimilar Marketing Application?
The agency changes its rhetoric on the subject, inviting speculation about whether a marketing application has been received.