FDA Approval Boosts SELARSDI by Alvotech and Teva
In exciting news for patients and healthcare providers, Alvotech (NASDAQ: ALVO) and Teva Pharmaceuticals have announced that the U.S. Food and Drug Administration (FDA) has approved a new presentation of their drug, SELARSDI (ustekinumab-aekn). This new 130 mg/26 mL solution, to be delivered in a single-dose vial for intravenous infusion, expands the label for treatment of adults suffering from Crohn's disease and ulcerative colitis.
New Opportunities for SELARSDI
This latest regulatory green light not only opens doors for SELARSDI but aligns its indications closely with those of the reference product—Stelara® (ustekinumab). With this approval, Alvotech and Teva anticipate a U.S. launch in the first quarter of 2025, marking a significant achievement for both organizations in their commitment to enhancing patient access to effective therapies.
CEO Insights on the Approval
Robert Wessman, Chairman and CEO of Alvotech, noted, “This step is fully in line with our plan to align the SELARSDI label with the reference product’s indications prior to launch next year. We are excited for the U.S. launch, especially following successful introductions of the first biosimilar ustekinumab in markets like Canada, Japan, and Europe.”
Teva's Commitment to Biosimilars
Thomas Rainey, Senior Vice President of U.S. Biosimilars at Teva, remarked on the expansion of SELARSDI’s indications as a significant milestone in their ongoing commitment to providing broader access to biosimilars in the U.S. He stated, “This allows us to serve patients battling gastrointestinal diseases as we approach the launch of SELARSDI in early 2025.”
Previous Approvals and Launch Plans
Earlier, in April 2024, the FDA approved SELARSDI in smaller doses for subcutaneous injection. The new intravenous formulation enhances the treatment scope for patients facing chronic conditions like moderate to severe plaque psoriasis and active psoriatic arthritis in both adults and pediatric patients aged six years and older.
Strategic Partnerships and Innovations
Alvotech has a strong partnership with Teva, which began with an agreement to commercialize several biosimilar candidates, including SELARSDI. This collaboration has since expanded to nine products, demonstrating an effective alliance aiming to leverage combined expertise in biosimilars. Both companies share a goal of delivering high-quality, affordable medications to patients worldwide.
Manufacturing Excellence
SELARSDI is developed using advanced manufacturing processes that mirror the innovative methods applied to the reference product, Stelara. By utilizing similar host cell lines and continuous perfusion processes for production, Alvotech reinforces its commitment to quality and safety in medication manufacturing.
Innovation in Immune-mediated Disease Treatment
Ustekinumab, the active ingredient in SELARSDI, is a monoclonal antibody that targets the p40 protein tied to two key interleukin cytokines (IL-12 and IL-23). This specificity plays a crucial role in combating chronic immune-mediated diseases, ensuring effective treatments for conditions ranging from psoriasis to inflammatory bowel diseases.
Expansion of Teva's Portfolio
As part of its portfolio management, Teva has also successfully launched SIMLANDI® (adalimumab-ryvk), a groundbreaking high-concentration biosimilar to Humira®. Since its release in May 2024, SIMLANDI has been met with positive reception, adding further credibility to Teva's leadership in the biosimilars sector.
Safety Information and Considerations
As with all medications, SELARSDI comes with indications and contraindications that must be carefully observed. It is essential for patients to consult with healthcare providers regarding potential risks like infections or hypersensitivity reactions. Monitoring and pre-treatment evaluations, especially concerning tuberculosis, are part of a proactive approach to patient safety.
Frequently Asked Questions
What is SELARSDI and what conditions does it treat?
SELARSDI is a biosimilar to Stelara® and is indicated for the treatment of moderate to severe plaque psoriasis, active psoriatic arthritis, Crohn's disease, and ulcerative colitis.
When is SELARSDI expected to launch in the U.S.?
SELARSDI is anticipated to launch in the first quarter of 2025 following the recent FDA approval for additional indications.
What benefits does the new intravenous formulation provide?
The new 130 mg/26 mL intravenous formulation offers a new delivery method that corresponds to different treatment needs, making it easier for healthcare providers to manage patient care.
Is SELARSDI safe for all patients?
SELARSDI is contraindicated for patients with hypersensitivity to ustekinumab and requires caution in patients with a history of infections. A thorough evaluation is necessary before treatment starts.
What is the significance of Teva’s partnership with Alvotech?
The collaboration allows both companies to combine their strengths in biosimilars, focusing on developing a portfolio that includes multiple products dedicated to improving patient access to innovative therapies.
