Teva and Alvotech Launch SELARSDI Injection in the U.S.

Teva Pharmaceuticals, a U.S. affiliate of Teva Pharmaceutical Industries Ltd., and Alvotech announced the availability of SELARSDI (ustekinumab-aekn) injection in the U.S., a biosimilar to Stelara (ustekinumab), for the treatment of psoriatic arthritis, plaque psoriasis, Crohn’s disease, ulcerative colitis, pediatric plaque psoriasis and pediatric psoriatic arthritis. This is the second biosimilar now available in the U.S. market under the Teva and Alvotech strategic partnership. The FDA has provisionally determined that SELARSDI will be interchangeable with the reference biologic Stelara, following the expiration of exclusivity for the first interchangeable biosimilar, on April 30, 2025.

“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. “The U.S. availability of SELARSDI reinforces Teva’s overall strategy to identify strategic business partners to develop and manufacture biosimilars while leveraging Teva’s commercial presence and experience to bring this and other products to the U.S. market.”

“The U.S. launch of SELARSDI is an important step for our partnership and reaffirms a joint commitment to providing more affordable treatment options for U.S. patients,” said Anil Okay, Chief Commercial Officer for Alvotech. “Alvotech’s fully integrated approach to development and manufacturing, coupled with our focus on biosimilars, enables us to continue expanding a portfolio of high-quality biologics and contribute meaningfully to lowering healthcare costs world-wide.”

SELARSDI is approved by the U.S. Food and Drug Administration (FDA) in several presentations, matching the approved presentations of the reference biologic Stelara (ustekinumab). The FDA has provisionally determined that all presentations of SELARSDI can be approved as interchangeable to Stelara (ustekinumab) injection upon expiry of exclusivity on April 30, 2025, for the first interchangeable biosimilar. The four approved presentations of SELARSDI are 45 mg/0.5 mL and 90 mg/mL in a single-dose prefilled syringe for subcutaneous injection, 45 mg/0.5 mL in a single-dose vial for subcutaneous injection and 130 mg/26 mL in a single-dose vial for intravenous infusion.

Ustekinumab is a human monoclonal antibody (mAb) that selectively targets the p40 protein, a component common to both interleukin (IL)-12 and IL-23 cytokines, which play crucial roles in treating immune-mediated diseases like psoriasis and psoriatic arthritis, and inflammatory diseases like Crohn’s disease and ulcerative colitis. Alvotech developed and produces SELARSDI using Sp2/0 cells and a continuous perfusion process, which are the same type of host cell line and process used in the production of Stelara.

In August 2020, Teva and Alvotech entered into a strategic partnership for the exclusive commercialization of five Alvotech biosimilar product candidates, and in July 2023, the partnership was extended to include two additional biosimilars and new presentations of two previously partnered products. Alvotech manages development and manufacturing, while Teva is responsible for the exclusive commercialization in the U.S., leveraging the experience and extensive sales and marketing infrastructure from Teva. Two biosimilars developed under the partnership have been given U.S. FDA approval: most recently, SELARSDI in April 2024; and in February 2024, SIMLANDI (adalimumab-ryvk), the first high-concentration, citrate-free interchangeable biosimilar to Humira, which was launched in the U.S. in May 2024.