FDA approves SELARSDI as interchangeable with Stelara

WASHINGTON - The U.S. Food and Drug Administration (FDA) has approved SELARSDI™ (ustekinumab-aekn) as interchangeable with the reference biologic Stelara® (ustekinumab) for all matching indications, effective April 30, 2025. Teva Pharmaceuticals, the U.S. affiliate of Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA), and Alvotech (NASDAQ: ALVO) announced the FDA’s decision, marking a significant step in expanding treatment options for patients with certain autoimmune diseases. According to InvestingPro data, Alvotech, with a market capitalization of $2.48 billion, has demonstrated remarkable revenue growth of over 426% in the last twelve months.

SELARSDI is now available in various presentations for the treatment of moderate to severe plaque psoriasis and active psoriatic arthritis in adults and children aged six and older. It is also approved for adults with moderately to severely active Crohn’s disease and ulcerative colitis.

The interchangeable designation means that SELARSDI can be substituted for Stelara at the pharmacy level without a prescriber’s intervention, potentially improving access to treatment and reducing healthcare costs. Teva and Alvotech expect this development to strengthen Teva’s position in the biosimilars market and contribute to the company’s growth strategy.

SELARSDI’s approved presentations include doses for subcutaneous injection and intravenous infusion, with formulations designed to target the p40 protein involved in inflammatory and immune responses. The biosimilar was developed using the same cell line and continuous perfusion process as Stelara, ensuring comparable quality and efficacy.

This approval builds on the strategic partnership between Teva and Alvotech, which began in August 2020 and expanded in July 2023 to include more biosimilar candidates. The partnership leverages Teva’s commercialization infrastructure and Alvotech’s development and manufacturing capabilities. With a strong current ratio of 2.35, Alvotech maintains healthy liquidity to support its development pipeline. The company’s next earnings report is scheduled for May 7, 2025, which InvestingPro subscribers can analyze using comprehensive financial health scores and detailed metrics available in the Pro Research Report.

Teva and Alvotech’s partnership has already seen the FDA approval of SIMLANDI® (adalimumab-ryvk), an interchangeable biosimilar to Humira® (adalimumab), which launched in the U.S. in May 2024. Additionally, the FDA is reviewing Biologics License Applications for three more biosimilar candidates from Alvotech, with approval dates expected in Q4 2025.

The announcement of SELARSDI’s approval is based on a press release statement from Teva Pharmaceuticals and Alvotech.

In other recent news, Alvotech SA reported a remarkable 400% increase in revenue for Q4 2024, reaching $492 million. Despite this significant growth, the company posted an earnings per share (EPS) loss of $0.22, falling short of the forecasted EPS of $0.01. The company launched biosimilars for HUMIRA and STELARA, which played a pivotal role in driving revenue. Alvotech also strengthened its operational capabilities by acquiring X Brain operations in Sweden, enhancing its R&D and manufacturing scale. The company projects revenue growth in 2025, aiming for a range between $570 million and $670 million. Furthermore, Alvotech plans to launch biosimilars for Prolia, Symphony, and EYLEA, while exploring a potential listing on the Stockholm Exchange. Analysts have noted that Alvotech’s ambitious growth targets could face execution risks, but the company remains optimistic about reaching $1.5 billion in revenues by 2028.

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