Revance & Mylan to Advance Development Program for Biosimilar to Botox

Posted By American Med Spa Association, Tuesday, June 2, 2020

Revance Therapeutics, Inc. and Mylan N.V. has announced Mylan’s decision to move forward with a development plan, under a 351(k) pathway, for a proposed biosimilar to Botox and Botox Cosmetic (onabotulinumtoxinA), the market-leading neuromodulator.

Feedback obtained from the U.S. Food and Drug Administration (FDA) during a Biosimilar Initial Advisory Meeting (BIAM) held in February 2019 indicated that the 351(k) regulatory pathway for an onabotulinumtoxinA product is viable. Based on this meeting, along with the results from additional characterization and analysis completed by Revance, the two companies are now moving forward with the development program.

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