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Viatris Readies Landmark Botox Biosimilar, Clinical Trial Coming In H1 2024

Key IND Filing With USFDA Planned For Year-End; Launch In 2026 Slated

 
• By Dean Rudge

Viatris has provided the latest on plans to bring a biosimilar to the world-renowned Botox cosmetic and therapeutic brand, while also discussing other opportunities on the slate, including its pipeline of complex injectables.

Botox
• Source: Shutterstock

Viatris says that it remains on track to file a US investigational new drug application by the end of this year for the firm’s proposed biosimilar to the world-renowned Botox (onabotulinumtoxinA) cosmetic and therapeutic brand, in partnership with Revance Therapeutics, ahead of plans to initiate a landmark clinical study program in the first half of 2024.

“Our Botox biosimilar program is progressing well, from the development characterization and validation of drug substance and drug product perspective,” commented Viatris’ president Rajiv

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