A Landmark FDA Approval: Alvotech and Teva’s SELARSDI™ Breakthrough
In a significant development for the biotech industry, Alvotech SA, a Luxembourg-based global biotech company, has achieved a major milestone. On May 5, 2025, Teva Pharmaceuticals and Alvotech announced that the U.S. Food and Drug Administration (FDA) has approved SELARSDI™ (ustekinumab-aekn) as interchangeable with the reference biologic Stelara® (ustekinumab). This approval, effective from April 30, 2025, marks a pivotal moment for both companies and patients alike.
SELARSDI™, a biosimilar developed by Alvotech, is now recognized as interchangeable with Stelara®, a widely used biologic for treating autoimmune disorders, among other conditions. This designation means that SELARSDI™ can be substituted for Stelara® without the intervention of the healthcare provider who prescribed the reference product. This interchangeability is a testament to the rigorous standards met by SELARSDI™ in terms of safety, efficacy, and quality.
The approval of SELARSDI™ as interchangeable with Stelara® is expected to have significant implications for the healthcare market. For patients, this development promises increased access to affordable treatment options. Biosimilars like SELARSDI™ typically offer a more cost-effective alternative to their reference biologics, potentially easing the financial burden on patients and healthcare systems.
For Alvotech, this FDA approval is a major achievement that underscores the company’s commitment to innovation and excellence in the biotech sector. Listed on the Nasdaq, Alvotech has been at the forefront of developing biosimilar medicines for a range of health issues, including autoimmune disorders, eye disorders, osteoporosis, and cancer. The company’s market capitalization stands at approximately $2.4 billion, reflecting its strong position in the industry.
The announcement of this FDA approval comes just days before Alvotech is set to release its first-quarter 2025 financial results. On May 8, 2025, at 8:00 am EDT (14:00 CET), Alvotech will host a webcast to discuss its financial performance for the quarter ended March 31, 2025. Investors and stakeholders are keenly anticipating these results, which will provide further insights into the company’s financial health and strategic direction.
This FDA approval is not just a win for Alvotech and Teva but also a significant step forward for the biotech industry as a whole. It highlights the growing acceptance and trust in biosimilars as viable alternatives to established biologics, paving the way for more innovation and competition in the market. As Alvotech continues to expand its portfolio of biosimilar medicines, the company is well-positioned to play a crucial role in shaping the future of healthcare.
In conclusion, the FDA’s approval of SELARSDI™ as interchangeable with Stelara® is a landmark achievement for Alvotech and Teva. It represents a significant advancement in the availability of affordable treatment options for patients and underscores the company’s leadership in the biotech industry. As Alvotech prepares to share its financial results, the biotech community eagerly awaits the next chapter in the company’s journey of innovation and growth.