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Revance recently announced their partnership with Mylan on the development of a possible biosimilar to Botox under the 351(k) regulatory pathway.
Pharmaceutical company Mylan recently announced that they will move forward in partnership with Revance Therapeutics on a development plan for a possible biosimilar to onabotulinumtoxinA (Botox) under the 351(k) regulatory pathway.
First introduced in the Biologics Price Competition and Innovation Act of 2009 (BPCI Act), the 351(k) pathway allows for biological products to be filed under a special licensing pathway if they are biosimilar with an existing FDA-licensed product. In February of last year, the FDA held a Biosimilar Initial Advisory Meeting (BIAM) where it was announced that onbotulinumtoxinA products were eligible.
The two companies signed a collaboration and license agreement in February 2018 for the development and regulatory approval of a biosimilar to Botox. This would be followed with commercialization by Mylan in the United States, Europe and other applicable markets globally, according to their latest press release.
“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 Mylan President Rajiv Malik. “This collaboration adds another high-profile, large-market, complex biologic, across both aesthetic and therapeutic categories, to our industry-leading biosimilars pipeline.”
The initial agreement included an upfront payment of $25 million to Revance. However, the companies amended the agreement in August 2019 to include an additional payment of $5 million to extend the time that Mylan could continue its collaboration and license agreement to develop the company’s biosimilar to Botox.
Mylan’s decision to move forward with the development program now issues the payment of $30 million to Revance.
The agreement also provides additional milestone payments of $70 million contingent on the achievement of further clinical and regulatory milestones, along with the eligibility of Revance to receive sales target milestone payments and royalties in all relevant markets, according to the release.
“We are pleased with Mylan’s decision to opt-in to the biosimilar to BOTOX development program, as it reflects our mutual confidence in the path forward,” adds Mark Foley, President and Chief Executive Officer of Revance Therapeutics. “Assuming regulatory approval, it would allow us to financially participate in the short-acting neuromodulator market, while focusing our commercial efforts on creating the new, long-acting neuromodulator category.”