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.
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Guidance is “emerging” that will allow sponsors to use data from products not licensed in their respective regions in applications.
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.
The agency changes its rhetoric on the subject, inviting speculation about whether a marketing application has been received.