Revance and Mylan to Advance Development Program for a Proposed Biosimilar to BOTOX

Shots:

• The two companies will advance the development program of a proposed biosimilar to BOTOX and BOTOX Cosmetic (onabotulinumtoxinA), under 351(k) pathways. The US FDA’s feedback during BIAM indicated that the 351(k) regulatory pathways for an onabotulinumtoxinA product is viable
• Following the advancement of the program, Revance will receive $30M as milestones and is eligible to receive additional $70M in milestone payments, contingent upon the achievement of further clinical & regulatory milestones and a commercial milestone along with royalties on sales of the product in all relevant market
• In Feb 2018, the two companies collaborated for a proposed biosimilar to BOTOX, followed with commercialization by Mylan in the US, EU, and applicable markets throughout ROW. In 2019, the companies amended the agreement to include an additional one-time payment of $5M to extend the period in which Mylan could choose to continue its collaboration and license agreement to develop Revance’s biosimilar to BOTOX

Click here ­to­ read full press release/ article | Ref: PRNewswire | Image: Mylan