Revance Therapeutics and Mylan N.V. announced Mylan’s decision to move forward with a development plan, under a 351(k) pathway, for a proposed biosimilar to Botox and Botox Cosmetic (onabotulinumtoxinA).
Mylan and Revance signed a collaboration and license agreement in February 2018 for the development and regulatory approval of a biosimilar to Botox, to be followed with commercialization by Mylan in the U.S., Europe, and applicable markets throughout the rest of the world. The agreement included an upfront payment of $25 million to Revance. In August 2019, the companies amended the agreement to include an additional one-time payment of $5 million to extend the period in which Mylan could choose to continue its collaboration and license agreement to develop Revance’s biosimilar to Botox. With Mylan’s decision to move forward with the development program announced today, a payment of $30 million is now payable to Revance by Mylan. Furthermore, the collaboration and license agreement also provides for an additional $70 million in milestone payments, contingent upon the achievement of further clinical and regulatory milestones. Additionally, per the agreement, Revance is eligible to receive sales target milestone payments and royalties in all relevant markets. “We are excited to move forward with Revance on a clear and achievable development pathway for what will potentially be the first biosimilar to Botox, and to leverage our worldwide reach and commercial expertise to maximize this exciting opportunity globally while expanding access to this important product for patients,” says Rajiv Malik, president of Mylan. “This collaboration adds another high-profile, large-market, complex biologic, across both aesthetic and therapeutic categories, to our industry-leading biosimilars pipeline.”