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AVT05 is Alvotech’s proposed biosimilar to Simponi and Simponi Aria, which are prescribed to treat a variety of inflammatory conditions.
January 27, 2025
By: Charlie Sternberg
Associate Editor
The U.S. Food and Drug Administration (FDA) has accepted for review Biologics License Applications (BLA) for AVT05, Alvotech’s proposed biosimilar to Simponi and Simponi Aria (golimumab), which are prescribed to treat a variety of inflammatory conditions. These are the first U.S. BLA filing acceptances announced for a biosimilar candidate to golimumab. The FDA review process for these applications is anticipated to be completed in the fourth quarter of 2025. “This is a significant st...
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