1. Generics Bulletin

Mylan Makes Decision On Potential First Botox Biosimilar

Launch In US By 2025 Has Been Mooted

 
• By Dean Rudge

Mylan first announced plans to develop a biosimilar of the Botox cosmetic and therapeutic brands back in 2018 through an alliance with Revance Therapeutics. More than two years later, a verdict has been reached by the company.

Young adult woman walking up the stairs with sun sport background.
Mylan will progress with plans to develop biosimilar Botox with Revance • Source: Shutterstock

Mylan will collaborate on a biosimilar to Botox (onabotulinumtoxinA) with Revance Therapeutics, the US-based company has decided, after more than two years of deliberation.

Analysis work completed so far by Revance, particularly around the complex task of product characterization, in tandem with the potential to file through the US Food and Drug Administration’s 351(k)

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