Alvotech Faces FDA Setback for AVT05 Biosimilar Application

Alvotech ( (ALVO) ) has issued an update.

On November 2, 2025, Alvotech announced that the U.S. FDA issued a complete response letter for its Biologics License Application for AVT05, a biosimilar candidate to Simponi®. The letter highlighted deficiencies in Alvotech’s Reykjavik facility, which must be resolved before approval. Despite the setback, the facility remains FDA-approved for current products. Alvotech has revised its 2025 financial outlook, anticipating lower revenues and adjusted EBITDA due to ongoing investments in facility improvements, which are expected to support future growth and product launches.

The most recent analyst rating on (ALVO) stock is a Hold with a $8.50 price target. To see the full list of analyst forecasts on Alvotech stock, see the ALVO Stock Forecast page.

Spark’s Take on ALVO Stock

According to Spark, TipRanks’ AI Analyst, ALVO is a Neutral.

Alvotech’s overall stock score reflects significant financial risks due to high leverage and negative equity, despite strong revenue growth and strategic market expansion highlighted in the earnings call. The technical analysis suggests a neutral outlook, while the high P/E ratio indicates potential overvaluation.

To see Spark’s full report on ALVO stock, click here.

More about Alvotech

Alvotech is a global biotech company focused on developing and manufacturing biosimilar medicines for patients worldwide. The company aims to be a leader in the biosimilar industry by providing high-quality, cost-effective products and services. Alvotech has a diverse pipeline targeting various medical conditions and has established strategic partnerships to expand its market reach across the United States, Europe, Asia, and other regions.

Average Trading Volume: 397,974

Technical Sentiment Signal: Sell

Current Market Cap: $2.31B

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