AEON Biopharma FDA Type 2b Meeting Feedback Clarifies Biosimilar Development Plan for ABP-450
AEON Biopharma received official minutes from its FDA Biosimilar Product Development Type 2b meeting for ABP-450, a proposed biosimilar to BOTOX. The FDA indicated that previously completed head-to-head studies versus BOTOX may be submitted as supportive evidence, with AEON expecting to advance the required bridging work and to submit an IND for a CMAP pharmacodynamic study in the fourth quarter of 2026.
Why it matters — The FDA feedback clarifies and potentially streamlines ABP-450's development path, giving AEON watchers greater visibility into the regulatory roadmap toward full-label U.S. market entry.