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FDA Accepts Alvotech’s Biosimilar Applications for Review
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FDA Accepts Alvotech’s Biosimilar Applications for Review

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Alvotech ( (ALVO) ) just unveiled an announcement.

On January 27, 2025, Alvotech announced that the FDA has accepted the Biologics License Applications for AVT05, a proposed biosimilar to Simponi and Simponi Aria, marking it as the first U.S. filing acceptance for a biosimilar candidate to golimumab. This development is part of Alvotech’s strategic partnership with Teva Pharmaceuticals, aimed at expanding biosimilar options for inflammatory conditions, and follows previous successes in gaining FDA approval for other biosimilars through this collaboration.

More about Alvotech

Alvotech is a biotech company focused on the development and manufacture of biosimilar medicines, with a global reach facilitated by strategic commercial partnerships. The company aims to deliver high-quality, cost-effective biosimilars for a range of conditions including autoimmune disorders and cancer. Alvotech collaborates with partners like Teva Pharmaceuticals to leverage its manufacturing capabilities and expand its market presence.

YTD Price Performance: -1.29%

Average Trading Volume: 118,880

Technical Sentiment Consensus Rating: Strong Sell

Current Market Cap: $3.92B

See more insights into ALVO stock on TipRanks’ Stock Analysis page.

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