AEON Biopharma shifts ABP-450 to biosimilar pathway targeting BOTOX; plans pivotal study in cervical dystonia

AEON Biopharma, Inc.

ABP-450 will pursue 351(k) biosimilar pathway using AbbVie's BOTOX as reference product.
Company plans a single pivotal Phase 3 comparative study in cervical dystonia.
Successful Phase 3 could support biosimilar determination for up to 8 therapeutic indications.
Biosimilar Initial Advisory Meeting with FDA scheduled for Q3 2024.

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