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Alvotech And Teva To Miss US Adalimumab Launch After Further FDA Setback

Firms Get Another CRL Over AVT02 High-Concentration Interchangeable Biosimilar

 
• By Dave Wallace

FDA approval for Alvotech and Teva’s AVT02 adalimumab biosimilar has once again failed to materialize as the agency issued another CRL over the product. The setback means the firms will miss their projected launch date of 1 July and will not be part of the pack launching multiple Humira rivals in the coming weeks.

Red and blue wooden figures left out of larger group of yellow figures
Teva and Alvotech will not be able to join the group launching adalimumab biosimilars at the start of July • Source: Shutterstock

While a host of further adalimumab biosimilars are getting ready to launch in the US within days, Teva and Alvotech will not be among them. As the latest US Food and Drug Administration action date for the pair’s partnered AVT02 rival to Humira arrived, the agency issued another complete response letter over the Alvotech-developed 100mg/ml biosimilar, meaning that Teva will not be in a position to launch at the start of July as planned.

In the coming days, a host of Humira biosimilars are due to launch under the terms of various settlements reached by sponsors

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