Alvotech Files Higher-Strength Adalimumab In US And EU
Rival To Humira 100mg/ml To Be Marketed By Teva And Stada Respectively
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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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.
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.
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.