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Alvotech’s SELARSDI Gains FDA Approval for Interchangeability with Stelara

Story Highlights

Alvotech ( (ALVO) ) has issued an announcement.

On May 5, 2025, Alvotech announced that the FDA approved its biosimilar SELARSDI (ustekinumab-aekn) as interchangeable with Stelara (ustekinumab), effective April 30, 2025. This approval allows SELARSDI to be used for treating conditions such as plaque psoriasis, psoriatic arthritis, Crohn’s disease, and ulcerative colitis, enhancing patient access to more affordable treatment options. This development is part of Alvotech’s strategy to expand its biosimilar portfolio and strengthen its market position, with additional biosimilar candidates under FDA review.

Spark’s Take on ALVO Stock

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

Alvotech’s overall stock score is low due to significant financial performance challenges, bearish technical indicators, and poor valuation metrics. The company’s strong revenue growth is overshadowed by its inability to achieve profitability and high financial leverage, highlighting risks of financial instability. Technical analysis confirms a downward trend, with valuation metrics reflecting these underlying issues.

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

More about Alvotech

Alvotech is a leading developer and manufacturer of biosimilars, focusing on expanding access to affordable biologic treatments globally. The company collaborates with Teva Pharmaceuticals for the commercialization of its biosimilar products in the U.S., leveraging Teva’s extensive sales and marketing infrastructure.

YTD Price Performance: -37.54%

Average Trading Volume: 126,181

Technical Sentiment Signal: Buy

Current Market Cap: $2.48B

See more data about ALVO stock on TipRanks’ Stock Analysis page.

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