Alvotech and Teva Announce Filing Acceptance of U.S. Biologics License Application for AVT06, a Proposed Biosimilar to Eylea® (aflibercept)
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Alvotech and Teva Pharmaceuticals have announced that the FDA has accepted the Biologics License Application for AVT06, a proposed biosimilar to Eylea. The regulatory approval process is expected to conclude by Q4 2025.
February 18, 2025 | 11:15 am
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POSITIVE IMPACT
Alvotech's BLA for AVT06, a biosimilar to Eylea, has been accepted by the FDA. This marks a significant step towards market entry, potentially boosting Alvotech's market position and revenue.
The acceptance of the BLA by the FDA is a critical milestone for Alvotech, indicating progress towards regulatory approval. This could enhance Alvotech's market position and lead to increased revenues if the biosimilar is approved and successfully launched.
CONFIDENCE 90
IMPORTANCE 80
RELEVANCE 90
POSITIVE IMPACT
Teva Pharmaceuticals, in collaboration with Alvotech, has had their BLA for AVT06 accepted by the FDA. This development could strengthen Teva's biosimilar portfolio and market presence.
Teva's involvement in the BLA acceptance for AVT06 could enhance its biosimilar offerings, potentially increasing its market share and revenues in the biosimilar segment if the product is approved.
CONFIDENCE 85
IMPORTANCE 70
RELEVANCE 70