Alvotech Files Higher-Strength Adalimumab In US And EU

Rival To Humira 100mg/ml To Be Marketed By Teva And Stada Respectively

 
• By David Wallace
  
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Alvotech has announced the filing of its AVT02 higher-strength adalimumab version of Humira 100mg/ml with both the FDA and the EMA, as well as disclosing expected decision dates. Teva will market the biosimilar in the US and Stada in Europe.

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Alvotech has filed its 100mg/ml biosimilar version of Humira in the US and EU • Source: Shutterstock

Alvotech has today announced that it has filed its 100mg/ml biosimilar version of Humira (adalimumab) in both the US and EU. The Alvogen sister company’s AVT02 higher-strength version of adalimumab had produced positive Phase I and Phase III data earlier this year. (Also see "Alvotech Announces Two Successful Adalimumab Studies" - Generics Bulletin, 13 May, 2020.)

Confirming that both the US Food and Drug Administration and European Medicines Agency had accepted submissions for AVT02, Alvotech insisted...

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