Botox Biosimilar in the Works

Mylan N.V. and Revance Therapeutics, Inc. are partnering to develop a biosimilar to BOTOX® (onabotulinumtoxinA).

"We have reviewed the work done to date by Revance and we are extremely excited and confident about our ability to bring this important product to market," says Mylan President Rajiv Malik in anews release. “Bringing an affordable biosimilar version of BOTOX to commercialization will offer patients a safe alternative to this popular and highly effective treatment."

The companies plan to work together to gain regulatory approval in the development of this biosimilar product, and commercialize this product in the U.S., Europe and applicable markets throughout the rest of the world.

The collaboration includes an upfront payment of $25 million to Revance, with contingent milestone payments upon achievement of additional clinical, regulatory and sales targets, plus sales royalties in all relevant markets.

Revance’s Botox rival --DaxibotulinumtoxinA for Injection (RT002) --is not yet approved by the U.S. Food and Drug Administration. They reported positive Phase III data for the treatment in December and said then that it planned to launch the drug in 2020, pending FDA approval.