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Mylan has agreed to move forward with Revance in the development plan of a biosimilar to onabotulinumtoxinA (BOTOX, AbbVie) under the 351(k) regulatory pathway from the U.S. FDA.
Mylan will move forward in a partnership with Revance Therapeutics on a development plan for a possible biosimilar to onabotulinumtoxinA (BOTOX, AbbVie) under the 351(k) regulatory pathway. The companies signed a collaboration and license agreement in February 2018 to work on the development and approval for a biosimilar to onabotulinumtoxinA and later commercialization by Mylan in the United States, Europe and other available markets, according to a press release.1
“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.”
The 351(k) pathway, which was first introduced in the Biologics Price Competition and Innovation Act of 2009 (BPCI Act), allows biological products to be filed under a special licensure pathway if they are biosimilar or interchangeable with an already FDA-licensed reference product.2 The U.S. Food and Drug Administration (FDA) held a Biosimilar Initial Advisory Meeting (BIAM) in February 2019 where they announced onabotulinumtoxinA products were eligible for this pathway.
Following this meeting Mylan and Revance amended their collaboration agreement to extend the period Mylan could choose to continue its collaboration and license agreement to develop the biosimilar to onabotulinumtoxinA. This amendment included a onetime payment of $5 million in addition to the initial $25 million payment to Revance under the original agreement. Revance will receive an additional $70 million from Mylan contingent upon the achievement of clinical and regulatory milestones.
“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. 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,” says Mark Foley, president and CEO of Revance Therapeutics.
1. Christl, L. (n.d.). FDA’s Overview of the Regulatory Guidance for the Development and Approval of Biosimilar Products in the US. Retrieved June 03, 2020, from https://www.fda.gov/files/drugs/published/FDA’s-Overview-of-the-Regulatory-Guidance-for-the-Development-and-Approval-of-Biosimilar-Products-in-the-US.pdf
2. Mylan. (2020, June 1). Revance and Mylan to Advance Development Program for Biosimilar to BOTOX® [Press release]. Retrieved June 3, 2020.