AEON Biopharma, Inc., a biopharmaceutical company developing ABP-450 (prabotulinumtoxinA) as a BOTOX® (onabotulinumtoxinA) biosimilar, today announced that the U.S. Food and Drug Administration (FDA) has scheduled a Biosimilar Biological Product Development (BPD) Type 2a meeting for ABP-450 on November 19, 2025, in line with prior guidance.
The meeting will focus on AEON’s analytical development plan under the 351(k) biosimilar pathway, including its framework for assessing key quality attributes and its initial similarity data. The objective of the discussion is to establish alignment with FDA on the scope and approach of the remainder of AEON’s analytical analysis – a foundational step in advancing ABP-450’s biosimilar development.
“The FDA’s scheduling of our BPD Type 2a meeting represents an important milestone in the development of ABP-450,” said Rob Bancroft, President and Chief Executive Officer of AEON. “Alignment with FDA on the analytical framework is essential in the biosimilar pathway, and we look forward to constructive dialogue on our proposed plan and early results as we advance ABP-450 as a potential biosimilar to BOTOX®.”
AEON expects to provide an update on the outcome of the meeting following its completion and receipt of official FDA minutes.
Upcoming Milestones
- 4Q 2025: FDA BPD Type 2a meeting expected to provide alignment on analytical development plan for ABP-450.
