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Established Biologics Do Not Require Name Change, AbbVie Says

Executive Summary

Company objects to FDA's plans to retrospectively adopt suffix-based nomenclature for existing biologic products; says resulting confusion, logistical challenges and burdens outweigh FDA's 'not compelling' rationale about perceived inferiority of biosimilars due to different naming conventions.

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Policy Reversal: FDA Will No Longer Require Suffixes For Older Biologics

New US FDA draft guidance says that the agency will no longer change the proper names of originator biologics to include a four-letter suffix, although the agency will continue to attach suffixes to future approvals.

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

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.

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

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.

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