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
  
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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.

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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,”...

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