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 regulatory approval, expected by Q4 2025.
The acceptance of the BLA by the FDA is a crucial milestone for Alvotech, indicating progress towards market entry. This development is likely to positively impact ALVO's stock as it moves closer to potentially launching a new product.
CONFIDENCE 90
IMPORTANCE 80
RELEVANCE 90
POSITIVE IMPACT
Teva Pharmaceuticals, in collaboration with Alvotech, has had its BLA for AVT06 accepted by the FDA. This is a positive development as it moves towards potential approval by Q4 2025.
Teva's partnership with Alvotech in developing AVT06 and the FDA's acceptance of the BLA is a positive step towards expanding its biosimilar portfolio, which could enhance its market position.
CONFIDENCE 85
IMPORTANCE 70
RELEVANCE 70