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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

Executive Summary

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 Champions Switching Data As Clock Ticks On Adalimumab Filing

Before the month is out, Alvotech hopes to hear back from the US FDA for its AVT02 high-concentration 100mg/ml biosimilar adalimumab candidate. The Icelandic firm, which remains embroiled in litigation with originator AbbVie, has reported top-line results from its key switching study. 

AbbVie Humira Lawsuit Withstands Alvotech Attack

Alvotech has failed in an attempt to dismiss US litigation initiated by AbbVie over Alvotech’s AVT02 proposed rival to higher-strength Humira. The company is expecting an FDA decision on the adalimumab biosimilar this month.

What’s Next? Five Things To Look Out For In September

In the month ahead, Alvogen’s biosimilars sister company Alvotech is anticipated to receive a USFDA decision on its biosimilar Humira candidate, while Hikma’s management will meet investors to discuss prospects for its Generics business.

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