1. Pink Sheet

AbbVie Looks To White House For Relief From US FDA Naming Guidance

 
• By Sue Sutter

Company says requirement that distinguishable suffixes be added to existing biologics creates the kind of economic burden targeted in President Trump’s executive order aimed at undoing the Affordable Care Act, which also established the biosimilar pathway.

The US FDA’s plan to require that sponsors of currently marketed biologics add a distinguishable nonproprietary name suffix is the type of “unnecessary regulatory burden” targeted by the Trump Administration, AbbVie Inc. believes.

In Feb. 13

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