AEON Biopharma FDA Type 2b Meeting Feedback Clarifies Biosimilar Development Plan for ABP-450
FDA indicated previously completed ABP-450 head-to-head studies versus BOTOX® may be submitted as supportive evidence; AEON expects to advance the required scientific bridging work AEON plans to submit an IND for CMAP pharmacodynamic study in the fourth quarter of 2026 AEON plans to leverage its analytical, pharmacodynamic, and existing comparative human evidence to support a potential streamlined development path ALISO VIEJO, Calif., Sept. 30, 2026 (GLOBE NEWSWIRE) -- AEON Biopharma, Inc. (“AEON” or the “Company”) (NYSE American: AEON), a biopharmaceutical company advancing ABP-450 as a biosimilar to BOTOX® (onabotulinumtoxinA) for therapeutic use to achieve full-label U.S. market entry, today announced receipt of the official minutes from its Biosimilar Biological Product Development (“BPD”) Type 2b meeting held with the U.S. Food and Drug Administration (“FDA” or the “Agency”) regarding ABP-450's development pathway.

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