SELARSDI™ Now Available in the U.S. Market
Teva Pharmaceuticals and Alvotech are excited to announce the availability of SELARSDI™ (ustekinumab-aekn) injection in the U.S. This biosimilar to Stelara® signifies a major step forward in providing enhanced treatment options for patients suffering from various autoimmune conditions.
FDA Approval and Interchangeability
The U.S. Food and Drug Administration (FDA) has approved SELARSDI for multiple indications, closely aligning it with the reference product, Stelara. With this approval, SELARSDI is now positioned as a cost-effective alternative for patients grappling with conditions such as plaque psoriasis and psoriatic arthritis.
Comprehensive Treatment Options for Patients
Approved for individuals aged six and older, SELARSDI addresses moderate to severe plaque psoriasis and active psoriatic arthritis, as well as adult patients with Crohn's disease and ulcerative colitis. This comprehensive approval showcases the commitment of Teva and Alvotech to supporting patients with complex, chronic inflammatory diseases.
Partnership Impacting Patient Care
Teva’s partnership with Alvotech marks a significant milestone as SELARSDI becomes the second biosimilar introduced in the U.S. under this collaboration. The two companies initially entered into a strategic agreement to commercialize five biosimilars, and the partnership has expanded over time, emphasizing a shared mission of improving accessibility to high-quality healthcare solutions.
Cost Savings in Healthcare
"Biosimilars like SELARSDI open pathways to more affordable healthcare options," commented Thomas Rainey, Senior Vice President of U.S. Biosimilars at Teva. The introduction of SELARSDI is expected to generate substantial cost savings, making effective treatments more available to patients and healthcare providers alike.
SELARSDI in the Global Market
Globally, SELARSDI is already recognized in markets such as Canada and Europe under different brand names. Teva and Alvotech’s collaborative efforts continue to drive the development and manufacturing of biologics, with ambitions of broadening the product's reach across various international landscapes.
Presentation and Administration of SELARSDI
SELARSDI is available in multiple formulations, ensuring flexibility for healthcare providers in administering treatment. The FDA has provisionally decided that SELARSDI can be viewed as interchangeable with Stelara upon the expiration of exclusivity for the first interchangeable biosimilar, anticipated in 2025.
Understanding Ustekinumab
Ustekinumab, the active component of SELARSDI, specifically targets the p40 protein linked to inflammatory responses, playing a crucial role in managing autoimmune diseases effectively. With its robust clinical basis, SELARSDI represents a significant advancement in targeted immune therapy.
Continuous Partnership for Future Growth
Teva and Alvotech’s alliance is built on a framework of mutual expertise and shared vision. The partnership's continued success is marked by their ability to launch and manage multiple biosimilar products effectively while maintaining a focus on patient well-being.
Frequently Asked Questions
What is SELARSDI and who is it for?
SELARSDI™ (ustekinumab-aekn) is a biosimilar injection approved for treating moderate to severe plaque psoriasis, psoriatic arthritis, Crohn’s disease, and ulcerative colitis in patients aged six and older.
How does SELARSDI compare to Stelara?
SELARSDI is a biosimilar to Stelara® and has been approved for indications similar to those of Stelara, providing a cost-effective alternative for patients.
What are the main benefits of using SELARSDI?
SELARSDI offers patients a more affordable treatment option and aims to improve accessibility to high-quality therapies for autoimmune conditions.
Who developed SELARSDI?
SELARSDI was developed through a strategic partnership between Teva Pharmaceuticals and Alvotech, leveraging their combined expertise in biosimilars.
When will SELARSDI be available in more countries?
The biosimilar has been launched in Canada and Europe and is under review in multiple global markets, indicating a commitment to expanding access internationally.
