Clinical ProgressABP-450 is ready to enter Phase 3 in cervical dystonia (CD), which is viewed as a 'low-risk' program since it is one in which neuromodulators have performed very consistently in clinical studies over the years.
Market ExpansionA biosimilar pathway potentially provides ABP-450 with a fast and low-cost approach to launch in multiple indications.
Regulatory ApprovalThe FDA has proven increasingly comfortable to grant fully extrapolated labels to biosimilars, even in instances where there was some ambiguity in terms of the mechanism of action.