AEON gets FDA Type 2b feedback on ABP-450 biosimilar pathway for BOTOX
FDA meeting minutes support a potentially narrower clinical program, with an IND for a pharmacodynamic study planned for the fourth quarter of 2026.
AEON Biopharma announced on September 30, 2026 that it had received official minutes from a Biosimilar Biological Product Development Type 2b meeting with the FDA covering the development pathway for ABP-450, its proposed biosimilar to BOTOX®. The FDA agreed in principle with AEON's proposed two-stage design for a comparative pharmacodynamic study using Compound Muscle Action Potential measurement in the extensor digitorum brevis muscle, consisting of an initial dose-finding stage followed by a comparative pharmacodynamic evaluation.1 The company intends to incorporate the FDA's feedback and expects to submit an IND for the CMAP study in the fourth quarter of 2026, with the study set to begin in the first quarter of 2027.1
The FDA also said that earlier comparative clinical studies run by Daewoong Pharmaceutical across several indications could be submitted as supportive evidence, provided AEON completes scientific bridging linking those results to U.S.-licensed BOTOX and to ABP-450 as currently manufactured, work the company plans to carry out.1 The FDA indicated any further clinical evidence would need to be sensitive enough to detect a meaningful product difference and should be shaped by residual uncertainty left after the comparative analytical assessment; AEON does not plan to start a standalone comparative efficacy study now, and will first weigh its combined analytical, pharmacodynamic and human evidence before deciding if more clinical work is needed.1 AEON plans to return to the FDA in 2027 with an integrated evidence package.1
On chronic migraine, the FDA asked AEON to provide analysis explaining the outcome of its earlier Phase 2 migraine prevention study, which the company intends to include in its eventual BLA submission.1
Separately, AEON determined that the Type 2b minutes do not preclude advancing ABP-450 toward a BLA under the 351(k) pathway, satisfying a condition tied to warrants issued in its July 2026 offering; as a result those Two-Year Milestone Warrants will expire November 16, 2026 unless exercised earlier.1
Written by readthrough’s AI from the linked primary sources and fact-checked against them automatically before publishing. Not investment advice.