REYKJAVIK, Iceland & PARSIPPANY, N.J. – The U.S. Food and Drug Administration (FDA) has expanded the approved use of SELARSDI (ustekinumab-aekn) to include the treatment of adults with Crohn's disease and ulcerative colitis. This new indication for SELARSDI, developed by Alvotech and commercialized by Teva Pharmaceuticals, aligns with the reference product Stelara’s indications in the United States.
Alvotech and Teva announced the FDA approval of SELARSDI in a new presentation, 130 mg/26 mL (5 mg/mL) solution in a single-dose vial for intravenous infusion. The U.S. launch for SELARSDI, including all approved indications, is anticipated in the first quarter of 2025.
SELARSDI's label expansion follows the FDA's approval in April 2024 of lower doses for subcutaneous use in treating moderate to severe plaque psoriasis and active psoriatic arthritis in adults and pediatric patients aged 6 and older. In June 2023, Alvotech and Teva reached a settlement and license agreement with the manufacturer of the reference biologic, which set a license entry date for SELARSDI in the U.S. market.
Ustekinumab, the active ingredient in SELARSDI, is a human monoclonal antibody targeting the p40 protein subunit used by both interleukin (IL)-12 and IL-23 cytokines. These cytokines are implicated in immune-mediated diseases such as psoriasis, psoriatic arthritis, ulcerative colitis, and Crohn’s disease.
Teva’s Senior Vice President, U.S. Biosimilars, Thomas Rainey, expressed enthusiasm about the expanded indications, emphasizing the company's commitment to increasing access to biosimilars in the U.S. Alvotech's Chairman and CEO, Robert Wessman, highlighted the successful launches of the biosimilar ustekinumab in Canada, Japan, and Europe, and the company's dedication to providing access to biosimilar treatments globally.
SELARSDI is part of a strategic partnership formed in August 2020 between Alvotech and Teva for the exclusive commercialization of five biosimilar product candidates, which has since expanded to include nine products.
This news article is based on a press release statement and focuses on the recent FDA approval of SELARSDI for additional indications. The information reflects the statements made in the press release without speculation or endorsement of the product's potential market impact.
In other recent news, Alvotech, a key player in the biosimilar market, reported a tenfold increase in its revenues for the first half of 2024, reaching $235.6 million. This growth is attributed to the successful strategy of the company in the biosimilar market, particularly with its Humira biosimilar in the United States. Alvotech anticipates delivering over 80% of its current 1.3 million unit order book in the second half of the year and projects revenues of $600 million to $800 million for 2025. The company has plans for at least 70 global biosimilar launches by the end of 2025. Despite a modest cash position and significant borrowings, Alvotech has successfully closed a refinancing deal to improve its debt maturity profile and reduce capital costs. The company remains confident in its 2024 guidance and anticipates a favorable shift in the coverage environment in 2025. These are among the recent developments in the company's operations.
InvestingPro Insights
The recent FDA approval for SELARSDI's expanded use aligns with Alvotech's (ALVO) growth trajectory. According to InvestingPro data, the company's revenue growth has been impressive, with a 374.55% increase over the last twelve months as of Q2 2024. This substantial growth is likely to be further bolstered by the new indications for SELARSDI.
An InvestingPro Tip suggests that analysts anticipate sales growth in the current year, which is consistent with the expected launch of SELARSDI in the first quarter of 2025. This expansion into new treatment areas could significantly contribute to Alvotech's revenue stream.
However, it's important to note that Alvotech is currently not profitable, with a negative operating income of $120.53 million over the last twelve months. Another InvestingPro Tip indicates that the company's short-term obligations exceed its liquid assets, which investors should consider when evaluating the stock.
Despite these challenges, the market seems optimistic about Alvotech's prospects. The stock has shown a 41.13% price total return over the past year, outperforming many of its peers. This performance may reflect investor confidence in the company's pipeline and strategic partnerships, such as the one with Teva Pharmaceuticals.
For investors seeking a more comprehensive analysis, InvestingPro offers 6 additional tips for Alvotech, providing deeper insights into the company's financial health and market position.
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