Revance and Mylan Move Forward With Development Plan for BOTOX Biosimilar


GoodwinWe have previously posted on the partnership between Revance and Mylan on a biosimilar to BOTOX®. Following favorable feedback from FDA and recent results from additional characterization and analysis studies performed by Revance, it was announced this week that Mylan plans to move forward with a development plan, under a 351(k) pathway, for this neuromodulator biosimilar. The press release also reported that “[w]ith 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.”

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