Mylan proposes a biosimilar of BOTOX to market

Mylan N.V. and Revance Therapeutics, Inc. announce a global collaboration and license agreement for the development and commercialization of a proposed biosimilar to BOTOX (onabotulinumtoxinA). BOTOX is a very popular market-leading neuromodulator approved for the treatment of multiple indications and usage in the United States with additional approvals globally.  

“This will be a significant opportunity for Mylan as we add another difficult-to-manufacture product to our pipeline. 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. Bringing an affordable biosimilar version of BOTOX to commercialization will offer patients a safe alternative to this popular and highly effective treatment,” comments Mylan president Rajiv Malik.  “Mylan is pleased to partner with Revance in the global collaboration, and share our scientific, regulatory and manufacturing capabilities and commercialization expertise. Our global platform enables investing in worldwide R&D collaborations for hard to make products that will benefit patients across the globe.”

The companies plan is to work together to gain regulatory approval in the development of this important 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.

“Global neuromodulator sales today are estimated at $4 billion and forecasted to grow steadily, exceeding $7 billion by 2024. Strategically, this partnership with Mylan allows Revance to remain focused on the development and launch of our own premium, long-acting RT002 neuromodulator, while also benefitting financially from potential future milestones and sales royalties on a short-acting biosimilar to BOTOX,” says Dan Browne, president and chief executive officer of Revance Therapeutics. “We believe Mylan is the ideal partner to co-develop, seek regulatory approval and market a biosimilar to BOTOX, due to its significant expertise in the field and its global commercial infrastructure.”

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