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.
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,
FDA To Review Teva and Alvotech Drug That Could Compete With Regeneron's Eylea
Teva Pharmaceutical Industries and partner Alvotech said the Food and Drug Administration agreed to review their AVTO6 treatment for eye disorders, which could compete with Regeneron Pharmaceuticals’ Eylea.
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.
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 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
JD Supra2h
First Circuit Rules Against Government in False Claims Act Case
On Feb. 18, in U.S. v. Regeneron Pharmaceuticals, the First Circuit Court of Appeals joined the Sixth Circuit and the Eighth Circuit in holding ...
US must meet tougher standard in Regeneron kickback lawsuit
Regeneron has won a court ruling that will make it harder for U.S. authorities to win a lawsuit accusing it of paying illegal ...
Regeneron Pharmaceuticals (REGN) Faces Mounting Pressure on Sales, Legal Fronts- Hagens Berman
Regeneron is also embroiled in a securities fraud class action lawsuit stemming from a significant stock price drop on October 31, 2024. Shares plunged $84.59 that day, wiping out approximately $9 ...
JD Supra5h
First Circuit Requires But-For Causation for FCA Liability Based on AKS Violations
Key Takeaways - The First Circuit ruled in United States v. Regeneron Pharmaceuticals, Inc., that the government must prove but-for causation ...
Why Regeneron's Price May Soon Break Out
Regeneron Pharmaceuticals' fourth quarter results beat my and Wall Street analysts' expectations. See why REGN stock is a top ...
Regeneron Pharmaceuticals, Inc. (REGN) Deadline Approaching: Berger Montague Advises Investors of Deadline in Securities Fraud Lawsuit
On April 10, 2024, the U.S. Department of Justice announced it had filed a complaint against Regeneron under the False Claims Act. According to the DOJ, the Company failed to report millions of ...
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 ...