AEON Biopharma Announces FDA BPD Type 2a Meeting for ABP-450 on November 19

Core Insights - The FDA has scheduled a Biosimilar Biological Product Development (BPD) Type 2a meeting for AEON's ABP-450 on November 19, 2025, which aligns with prior guidance [1][4] - The meeting will focus on AEON's analytical development plan under the 351(k) biosimilar pathway, aiming to establish alignment with the FDA on the analytical framework [2][3] Company Overview - AEON Biopharma is developing ABP-450 as a biosimilar to BOTOX, targeting the U.S. therapeutic neurotoxin market, which exceeds $3.0 billion annually [5] - ABP-450 is manufactured by Daewoong Pharmaceutical and is already approved as a biosimilar in India, Mexico, and the Philippines [5] - The company holds exclusive development and distribution rights for therapeutic indications of ABP-450 in the U.S., Canada, the EU, the UK, and other territories [5]