AEON Biopharma, Inc. announced on September 30, 2026, that it has received the official minutes from a Biosimilar Biological Product Development (BPD) Type 2b meeting with the U.S. Food and Drug Administration (FDA) regarding its candidate ABP-450. ABP-450 is proposed as a biosimilar to BOTOX (onabotulinumtoxinA). The FDA agreed in principle with the Company’s proposed two-stage design for a comparative pharmacodynamic study using Compound Muscle Action Potential (CMAP) measurement in the extensor digitorum brevis muscle. This study will consist of an initial dose-finding stage followed by a comparative pharmacodynamic evaluation. The FDA provided recommendations intended to strengthen the study’s ability to demonstrate assay sensitivity. AEON intends to incorporate this feedback and expects to submit an Investigational New Drug (IND) application for the CMAP study in the fourth quarter of 2026, with the study expected to initiate in the first quarter of 2027.
The FDA indicated that comparative clinical studies previously conducted by Daewoong Pharmaceutical across several indications—including blepharospasm, upper limb spasticity, glabellar lines, and lateral canthal lines—may be submitted for consideration as supportive evidence. These studies evaluated ABP-450 relative to BOTOX across a range of indications, doses, and muscles, with each study meeting its pre-specified non-inferiority endpoint. However, these studies can only be submitted subject to appropriate scientific bridging to U.S.-licensed BOTOX and between the ABP-450 drug product used in each study and ABP-450 as currently manufactured. AEON intends to complete the necessary bridging work to support this evidence within the totality of evidence for ABP-450.
The FDA emphasized that if additional clinical evidence is ultimately needed, it should be sufficiently sensitive to detect a meaningful difference between the products. The Agency suggested that more sensitive measures of biological activity, rather than traditional clinical efficacy endpoints, could be considered. In line with this guidance, AEON does not intend to initiate a standalone comparative efficacy study at this time. Instead, the Company plans to evaluate the totality of its analytical, pharmacodynamic, and comparative human evidence to determine whether additional clinical evidence is scientifically necessary. The Company plans to return to the FDA in 2027 with its integrated evidence package. Additionally, the FDA invited AEON to provide analyses supporting the rationale for the outcome of a previously conducted Phase 2 study for the prevention of migraine headache, which the Company intends to complete and provide as part of its Biologics License Application (BLA) submission.
In other business developments, AEON announced that the expiration date of its Two-Year Milestone Warrants, issued in July 2026, has been accelerated. The Company determined that the FDA meeting minutes do not preclude advancement of ABP-450 toward a BLA under the Section 351(k) biosimilar pathway. Consequently, the warrants will now expire on November 16, 2026, rather than July 15, 2028, unless exercised prior to that date.
