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Alvotech Welcomes EU Endorsement Of Higher-Strength Adalimumab

Emphasizes Global Approach As Action Still Awaited From US FDA On AVT02 Humira Rival

 
• By Dave Wallace

Alvotech has highlighted the significance to its global development strategy of the EU’s recent approval of its AVT02 higher-strength adalimumab biosimilar. However, one month on from approval, European marketing partner Stada has yet to confirm launch plans.

Thumbs Up Approval Endorsement
The formal EU approval was the first for AVT02 • Source: Alamy

Alvotech says the European Commission’s approval of its AVT02 rival to the higher-strength 100mg/ml version of Humira (adalimumab) represents a welcome endorsement of the candidate, especially in the context of its wider global plans for the biosimilar.

The mid-November approval of AVT02 – which followed as expected from the positive opinion received from the European Medicines Agency’s Committee for Medicinal Products for Human Use in mid-September, under the names Hukyndra and Libmyris (Also see "Alvotech And Stada Gain Second Ever Higher-Strength Adalimumab

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