Alvotech and Teva Secure FDA Approval for New SELARSDI™ Presentation, Expanding Indications
Wednesday, October 23, 2024
Alvotech and Teva Pharmaceuticals have announced that the U.S. Food and Drug Administration (FDA) has approved SELARSDI (ustekinumab-aekn) in a new 130 mg/26 mL (5 mg/mL) solution for intravenous infusion.
SIMLANDI® (adalimumab-ryvk), received FDA approval in February 2024 as the first high-concentration, citrate-free interchangeable biosimilar to Humira® (adalimumab), with its U.S. launch taking place in May 2024.
SELARSDI has already been launched internationally under various names, including JAMTEKI in Canada, UZPRUVO in Europe, and USTEKINUMAB BS (F) in Japan.
This approval moves SELARSDI closer to aligning its label with the reference product Stelara® (ustekinumab) in the U.S., with its launch anticipated in the first quarter of 2025.
The expanded approval builds upon previous FDA authorisations, including SELARSDI 45 mg/0.5 mL and 90 mg/mL for subcutaneous use, approved in April 2024 for moderate to severe plaque psoriasis and active psoriatic arthritis in both adults and pediatric patients aged six and older.
This follows a settlement and licensing agreement announced in June 2023, granting SELARSDI a U.S. launch date no later than February 2025.
Developed by Alvotech using Sp2/0 cells and a continuous perfusion process—similar to the method used in Stelara's production—SELARSDI is a monoclonal antibody targeting the p40 protein of interleukin (IL)-12 and IL-23.
These cytokines play an essential role in treating immune-mediated diseases such as psoriasis, psoriatic arthritis, Crohn’s disease, and ulcerative colitis.
Alvotech and Teva's partnership began in 2020, initially covering five biosimilar product candidates, including SELARSDI. Since then, it has expanded to include nine products.
Under the agreement, Alvotech oversees development and manufacturing, while Teva manages U.S. commercialization through its established sales and marketing network.
Source: tevapharm.com
