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 candidate to golimumab, with the 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 in the U.S. biosimilar market.
The FDA's acceptance of the BLA is a crucial step for Alvotech, potentially leading to market entry in the U.S. This could enhance Alvotech's market position and revenue prospects.
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®, reinforcing its commitment to biosimilars.
Teva's strategic partnership with Alvotech and the FDA's acceptance of the BLA could enhance its biosimilar offerings, potentially increasing its market share and revenue.
CONFIDENCE 85
IMPORTANCE 70
RELEVANCE 70