AEON Biopharma has appointed Dr. Paul Lee, M.D., Ph.D., as interim regulatory director, effective immediately, as the company advances its biosimilar candidate ABP-450.
Dr. Lee, who previously served as deputy director of the FDA’s Office of Neuroscience and director of the Division of Neurology 2, brings over seven years of FDA experience in drug review and regulatory oversight. His tenure at the agency included roles in the Office of New Drugs, where he supervised neurological and psychiatric conditions such as migraine, epilepsy, stroke, multiple sclerosis, and neurodegenerative diseases. Prior to the FDA, he worked as a clinician at the National Human Genome Research Institute and as a medical reviewer for the Undiagnosed Diseases Network.
In his new role at AEON, Dr. Lee will lead the regulatory strategy for ABP-450, AEON’s biosimilar to BOTOX (onabotulinumtoxinA), under the FDA’s 351(k) biosimilar pathway. The drug is being developed for therapeutic indications across the United States, Canada, the European Union, the United Kingdom, and other international markets. AEON has previously engaged Dr. Lee through Clintrex Research LLC, an affiliate of BlueRidge Life Sciences, for regulatory consulting on ABP-450.
ABP-450 is manufactured by Daewoong Pharmaceutical in a facility authorized by the FDA, Health Canada, and the European Medicines Agency. The same botulinum toxin complex is already approved and commercialized under the brand name Jeuveau for aesthetic indications by Evolus, Inc.
Dr. Lee holds an M.D. and a Ph.D. in Neuroscience from the University of Maryland and is board-certified in neurology with a special qualification in child neurology.
