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FDA Accepts Alvotech’s BLA for Biosimilar AVT03

Story Highlights
  • Alvotech’s FDA application for AVT03, a biosimilar to Prolia® and Xgeva®, was accepted.
  • This acceptance marks a key step in Alvotech’s mission to offer affordable biologic medicines in the U.S.
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FDA Accepts Alvotech’s BLA for Biosimilar AVT03

Alvotech ( (ALVO) ) has issued an announcement.

On March 18, 2025, Alvotech announced that the FDA has accepted the Biologics License Application for AVT03, a proposed biosimilar to Prolia® and Xgeva®. This milestone is significant for Alvotech as it advances its mission to provide affordable biologic medicines, potentially impacting the treatment of osteoporosis and bone-related diseases in the U.S. market. The acceptance of AVT03’s application marks a critical step in Alvotech’s collaboration with Dr. Reddy’s Laboratories, which is responsible for the registration and commercialization of AVT03 in the U.S.

More about Alvotech

Alvotech is a global biotech company focused on developing and manufacturing biosimilar medicines. It aims to be a leader in the biosimilar space by offering high-quality, cost-effective products and services. The company has a pipeline of biosimilar candidates targeting various conditions, including autoimmune disorders and osteoporosis, and has formed strategic partnerships to expand its global reach.

YTD Price Performance: -14.06%

Average Trading Volume: 165,680

Technical Sentiment Consensus Rating: Buy

Current Market Cap: $3.41B

For a thorough assessment of ALVO stock, go to TipRanks’ Stock Analysis page.

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