FDA, Alvotech and Teva Pharmaceuticals

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.
Teva and Alvotech get FDA review acceptance for its proposed biosimilar to Eylea
Alvotech and Teva Pharmaceuticals said on Tuesday that the U.S. FDA has accepted for review a Biologics License Application for AVT06. Read more here.
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.
Alvotech and Teva Announce Filing Acceptance of U.S. Biologics License Application for AVT06, a Proposed Biosimilar to Eylea® (aflibercept)
In addition to AVT06, which is a biosimilar candidate for Eylea ® (aflibercept) 2 mg, Alvotech is currently also developing AVT29, a biosimilar candidate for Eylea ® HD (aflibercept) 8 mg. Teva also holds commercialization rights for AVT29 in the U.S.
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 Pharm CEO calls on Trump for faster US drug approvals
U.S. President Donald Trump's administration needs to speed up generic drug approvals and exempt some drugs from funding ...
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 ...
Teva CEO responds to 25% share price fall
Teva CEO Richard Francis said that he had not expected such a harsh reaction from the market but he sees a positive side to ...
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Teva files to raise first capital since 2016
Teva has not raised capital since it acquired Actavis from Allergan in 2016 - a deal worth nearly $40 billion and for which ...
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Axsome secures top drug’s future with Teva patent settlement
Axsome Therapeutics gained more than $1 billion in market value Monday, after the brain drug developer disclosed a patent ...
Teva Pharm CEO calls for faster US generic drug approvals
U.S. President Donald Trump's administration needs to speed up generic drug approvals and exempt some drugs from funding ...