FDA Approves Alvotech and Teva's SELARSDI (ustekinumab-aekn) for Crohn's Disease and Ulcerative Colitis
Key Insights
The FDA has approved a new intravenous infusion presentation of SELARSDI (search), expanding its label to include Crohn’s disease (search) and ulcerative colitis (search).
This approval aligns SELARSDI (search)'s indications more closely with its reference product, Stelara (ustekinumab), enhancing its market potential.
SELARSDI (search)'s U.S. launch for all approved indications is anticipated in Q1 2025, offering a biosimilar option for patients.
The U.S. Food and Drug Administration (FDA) has approved a new presentation of SELARSDI (search) (ustekinumab-aekn), a biosimilar developed by Alvotech and commercialized by Teva Pharmaceuticals. The approval expands the label to include the treatment of adults with moderately to severely active Crohn’s disease (search) and ulcerative colitis (search). This new presentation is a 130 mg/26 mL (5 mg/mL) solution in a single-dose vial for intravenous infusion.
This approval marks a significant step for SELARSDI (search), as it further aligns its label with the indications of the reference product Stelara (ustekinumab) in the U.S. The launch of SELARSDI for all approved indications is expected in the first quarter of 2025.
Strategic Alignment and Market Entry
Robert Wessman, Chairman and CEO of Alvotech, stated, "We welcome this step which is fully in line with our plan to align the SELARSDI (search) label with the indications of the reference product before launch next year." He also highlighted the successful launches of the first ustekinumab biosimilar in Canada, Japan, and Europe, underscoring the company's commitment to increasing access to ustekinumab for patients worldwide.
Thomas Rainey, Senior Vice President, U.S. Biosimilars at Teva, added, "We are thrilled with the expansion of SELARSDI (search)’s indications, marking another significant milestone in Teva’s commitment to increasing access to biosimilars in the U.S. This development allows us to serve patients battling gastrointestinal diseases as the U.S. launch of SELARSDI approaches in early 2025."
Mechanism of Action and Manufacturing
SELARSDI (search) is a human monoclonal antibody that selectively targets the p40 protein, a component common to both interleukin (IL)-12 and IL-23 (search) cytokines. These cytokines play crucial roles in treating immune-mediated diseases such as psoriasis (search), psoriatic arthritis (search), ulcerative colitis (search), and Crohn’s disease (search).
Alvotech develops and produces SELARSDI (search) using Sp2/0 cells and a continuous perfusion process, mirroring the production of Stelara. This ensures a high degree of similarity between the biosimilar and the reference product.
Partnership and Portfolio Expansion
Alvotech and Teva entered a strategic partnership in August 2020 for the exclusive commercialization of several Alvotech biosimilar product candidates, including SELARSDI (search). The partnership has since expanded to include nine products. Alvotech manages development and manufacturing, while Teva is responsible for commercialization in the U.S.
In addition to SELARSDI (search), the FDA approved SIMLANDI (search) (adalimumab-ryvk (search)), a high-concentration, citrate-free interchangeable biosimilar to Humira (adalimumab), in February 2024. SIMLANDI was launched in the U.S. in May 2024, further demonstrating the strength of the Alvotech-Teva partnership.
Prior Approvals and Future Outlook
In April 2024, the FDA approved SELARSDI (search) for the treatment of moderate to severe plaque psoriasis (search) and active psoriatic arthritis (search) in adults and pediatric patients 6 years and older. With the latest approval, SELARSDI is poised to offer a more accessible and potentially cost-effective treatment option for a broader range of patients with immune-mediated diseases.