Alvotech and Teva Announce Filing Acceptance of U.S. Biologics License Applications for AVT05, a Proposed Biosimilar to Simponi® and Simponi Aria® (golimumab)
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Alvotech and Teva Pharmaceuticals have announced the FDA's acceptance of Biologics License Applications for AVT05, a proposed biosimilar to Simponi® and Simponi Aria®. This marks the first U.S. BLA filing acceptance for a biosimilar to golimumab, with FDA review expected to conclude in Q4 2025.
January 27, 2025 | 11:15 am
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POSITIVE IMPACT
Alvotech's BLA for AVT05, a biosimilar to Simponi®, has been accepted by the FDA, marking a significant milestone as the first U.S. BLA for a golimumab biosimilar. The FDA's decision is expected by Q4 2025.
The acceptance of the BLA by the FDA is a positive development for Alvotech, indicating progress in their biosimilar pipeline. This could lead to future revenue opportunities if approved, positively impacting the stock.
CONFIDENCE 90
IMPORTANCE 80
RELEVANCE 90
POSITIVE IMPACT
Teva Pharmaceuticals, in partnership with Alvotech, has achieved FDA acceptance for the BLA of AVT05, a biosimilar to Simponi®. This is a key step in expanding their biosimilar portfolio in the U.S.
The FDA's acceptance of the BLA is a positive indicator for Teva's strategy in the biosimilar market, potentially enhancing their product offerings and market position, which could positively influence their stock.
CONFIDENCE 85
IMPORTANCE 70
RELEVANCE 70