Biosimilar, Teva Pharmaceuticals and FDA

FDA Accepts Alvotech/Teva’s Application for Eylea Biosimilar
So far, five biosimilars that reference Eylea 2 mg have been approved by the FDA. Alvotech/Teva expect to regulatory approval for its biosimilar to be completed in the fourth quarter of 2025.
Teva and Alvotech gets FDA review acceptance for its proposed biosimilar to Eylea
Alvotech (NASDAQ:ALVO) and Teva Pharmaceuticals (NYSE:TEVA) said on Tuesday that the U.S. FDA has accepted for review a Biologics License Application for a biosimilar targeting Regeneron’s (REGN) blockbuster eye disease therapy,
Alvotech and Teva Announce Filing Acceptance of U.S. Biologics License Application for AVT06, a Proposed Biosimilar to Eylea® (aflibercept)
Alvotech (NASDAQ: ALVO), a global biotech company specializing in the development and manufacture of biosimilar medicines for patients worldwide, and Teva Pharmaceuticals, a U.S. affiliate of Teva Pharmaceutical Industries Ltd.
Alvotech and Teva Pharmaceuticals announce FDA accepts Biologics License Application for AVT06
Alvotech and Teva Pharmaceuticals announced the US Food and Drug Administration (FDA) has accepted for review a Biologics License Application (BLA) for AVT06, Alvotech’s proposed biosimilar to Eylea (aflibercept) 2 mg.
FDA To Review Teva and Alvotech Drug That Could Compete With Regeneron's Eylea
Key Takeaways Teva Pharmaceutical Industries and partner Alvotech said the Food and Drug Administration agreed to review their AVTO6 treatment for eye disorders. The treatment is a biosimilar that could compete with Regeneron Pharmaceuticals’ Eylea.
FDA Accepts Alvotech’s Eylea Biosimilar for Review
The U.S. Food and Drug Administration (FDA) has approved for review a Biologics License Application (BLA) for AVT06, Alvotech’s proposed biosimilar to Eylea (aflibercept), a biologic used to treat eye disorders, including those that can cause vision loss or blindness.
Alvotech and Teva’s BLA filing for AVT06 accepted by FDA
Alvotech (ALVO) and Teva Pharmaceuticals (TEVA) announced that the FDA has accepted for review a Biologics License Application, or BLA, for
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Alvotech and Teva Pharmaceuticals Announce FDA Review Acceptance of Biosimilar AVT06 for Eylea®
Alvotech and Teva Pharmaceuticals announced that the FDA has accepted the Biologics License Application for AVT06, a proposed biosimilar to Eylea® (aflibercept), used in treating serious eye ...
Celltrion Expands Biosimilar Portfolio in the European Union Following European Commission Approval of Two Biosimilars
Celltrion today announced that the European Commission (EC) has granted marketing authorization for three products across two ...
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Personal Jurisdiction Considerations for International Biosimilars Companies
The Federal Circuit recently issued decisions in a pair of appeals that provide guidance about when international filers of abbreviated ...
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Alvotech and Teva Pharmaceuticals Announce FDA Acceptance of Biologics License Application for AVT06, a Biosimilar Candidate to Eylea®
Alvotech and Teva Pharmaceuticals have announced the FDA's acceptance of their Biologics License Application for AVT06, a proposed biosimilar to Eylea®, aimed at treating various eye disorders ...