Re: RVNC / VTRS Botox biosimilar
On today's 1Q22 CC, VTRS President, Rajiv Malik said that FDA approval of the Botox biosimilar (via the 351(k) biosimilar pathway) is now targeted for 2026. Previously, VTRS had said that the 351(k) submission was expected in 2024, suggesting that FDA approval was expected in 2025. The later expected approval is due to a delay stemming from RVNC's change to its working cell bank, which provides the bulk drug substance for both Daxi and the Botox biosimilar.