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Alvotech Sets Sights On Stelara Submission By Close Of 2022

Company In Strong Position To Capitalize On Ustekinumab Opportunity

 
• By Dean Rudge

Tipped to bring in revenues from its proposed Stelara biosimilar of $600m in 2027, Alvotech has confirmed plans for a potentially landmark filing with major regulators by the end of the year.

Andrii Yalanskyi/Alamy Stock Photo
With positive data in hand, filings are set to follow • Source: Shutterstock (Andrii Yalanskyi / Alamy Stock P/Alamy Stock Photo)

As one of only a handful of companies to announce announced positive topline results from Phase III clinical trials involving a proposed Stelara (ustekinumab) biosimilar candidate, Alvotech has confirmed plans to “work towards filing the product in major markets” before the end of 2022.

Earlier this year, the Icelandic firm reported positive results from a key study for its AVT04 proposed biosimilar to Stelara, with pharmacokinetic similarity

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More from Products

Amneal Proud To Be ‘Made In America’ And Ready To Scale Up Its US Manufacturing

 
• By Urtė Fultinavičiūtė

Amneal has set itself apart from competitors who are scrambling to find alternatives if proposed US pharmaceutical tariffs come into place. For the New Jersey-based firm, this is an opportunity to embrace its American identity and open a new chapter of growth.

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• By Dave Wallace

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