Aeon Positive Outcome from FDA Biosimilar Advisory Meeting

 – Company is aligned with the FDA on next steps for a 351(k) regulatory pathway to approval for ABP-450 (prabotulinumtoxinA) as a biosimilar utilizing BOTOX® (onabotulinumtoxinA) as the reference product –

– Comparative analytical studies anticipated to commence in Q4 2024 –

– Expect to conduct a Biosimilar Biological Product Development (BPD) Type 2 meeting with FDA in 2025 to review the results from the analytical studies and confirm remainder of proposed study package –

https://www.globenewswire.com/news-release/2024/09/30/2955158/0/en/AEON-Biopharma-Announces-Positive-Outcome-from-FDA-Biosimilar-Advisory-Meeting.html