Teva and Alvotech Launch SELARSDI, a Stelara Biosimilar, in the U.S.

• Teva Pharmaceuticals and Alvotech have launched SELARSDI (ustekinumab-aekn) in the U.S., a biosimilar to Stelara for treating multiple immune-mediated and inflammatory diseases.

• SELARSDI has received FDA approval and will be interchangeable with Stelara following the expiration of exclusivity for the first interchangeable biosimilar on April 30, 2025.

Teva Pharmaceuticals, a U.S. affiliate of Teva Pharmaceutical Industries Ltd., and Alvotech have announced the availability of SELARSDI (ustekinumab-aekn) in the United States. This biosimilar to Stelara (ustekinumab) is approved for multiple indications, including psoriatic arthritis, plaque psoriasis, Crohn’s disease, ulcerative colitis, pediatric plaque psoriasis, and pediatric psoriatic arthritis.

SELARSDI marks the second biosimilar introduced in the U.S. under the Teva-Alvotech strategic partnership. The FDA has provisionally determined that SELARSDI will be interchangeable with Stelara upon the expiration of exclusivity for the first interchangeable biosimilar on April 30, 2025. This approval allows for four different presentations of SELARSDI, mirroring those of Stelara, including prefilled syringes and vials for both subcutaneous and intravenous administration.

Teva and Alvotech entered into a strategic collaboration in August 2020 for the commercialization of five biosimilar candidates, later expanding the partnership in July 2023 to include additional products. Under this agreement, Alvotech handles development and manufacturing, while Teva manages exclusive commercialization in the U.S.

“Biosimilars like SELARSDI create opportunities for cost savings across the healthcare system, and we are proud to be able to introduce our second biosimilar treatment option in partnership with Alvotech to U.S. patients and providers,” said Thomas Rainey, Senior Vice President, U.S. Biosimilars at Teva.