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Alvotech Files Higher-Strength Adalimumab In US And EU

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

 
• By Dave Wallace

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.

Close up of EU and US flag
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.)

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