Biosimilar Being Developed for Botox


In a transatlantic collaboration, Mylan N.V. (Pittsburgh, Pennsylvania) and Revance Therapeutics, Inc. (Hertsfordshire, England) have reached an agreement to collaborate on the development and commercialization of a proposed biosimilar to for onabotulinumtoxinA (Botox; Dublin, Ireland). OnabotulinumtoxinA is a market-leading neuromodulator approved for the treatment of cervical dystonia, headache, and focal spasticity. Adding this product to their portfolio Mylan's long-term commitment to the development and commercialization of biosimilars and complex products globally. Together, Mylan and Revance aim to develop a biosimilar and gain regulatory approval for it in the US, Europe, and other markets around the globe.

The agreement includes an upfront payment of $25 million to Revance, and milestone payments contingent on achieving clinical, regulatory and sales targets. REvance will also receive sales royalties in all relevant markets.

"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," commented 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."

"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," said 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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