- AEON Biopharma (NYSE:AEON) on Tuesday said that it had announced plans to advance a single clinical development study in cervical dystonia for ABP-450 injection, utilizing the 351(k) regulatory pathway for biosimilars with BOTOX ((onabotulinumtoxinA)) as the reference product.
- The company added that under the 351(k) biosimilar regulatory pathway, its plans rely upon extensive analytical and preclinical testing, much of which has already been completed.
- Following the FDA meeting scheduled to take place in the third quarter of 2024, the company expects to move ahead with a planned Phase 3 CD study in about 400 patients to evaluate a direct comparison of ABP-450 to BOTOX.
- The purpose of the study is to demonstrate non-inferiority to BOTOX and would serve as the basis for a BLA filing.
- Press release.
2024-07-09