Alvotech (ALVO) and Teva Pharmaceutical (TEVA) said Monday that the US Food and Drug Administration has accepted to review their biologics license applications for AVT05 to treat inflammatory conditions.
The review process is expected to be completed in Q4.
This comes after the achievement of positive top-line results in April 2024 from a confirmatory clinical study comparing AVT05 with biosimilar Simponi in patients with rheumatoid arthritis.
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