AEON Biopharma has kicked off the primary analytical studies that are required for its ABP-450 proposed biosimilar to Botox (onabotulinumtoxinA) to fulfill the standard regulatory requirements for a comparative analytical assessment, under plans to file eventually the biosimilar via the US Food and Drug Administration’s 351(k) regulatory pathway.
The development comes after AEON last year received the formal minutes from a biosimilar initial advisory...