Teva, Alvotech: FDA approves interchangeability for SELARSDI with Stelara

Teva Pharmaceuticals (TEVA) and Alvotech (ALVO) announced that the U.S. Food and Drug Administration has approved SELARSDI injection as interchangeable with the reference biologic Stelara. As of April 30, 2025, SELARSDI is available and interchangeable in all presentations matching the reference product, including the treatment of adults and pediatric psoriatic arthritis and plaque psoriasis, as well as Crohn’s disease, and ulcerative colitis. 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. 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 its experience and extensive sales and marketing infrastructure. Two biosimilars developed under the Teva – Alvotech partnership have been granted FDA approval with interchangeability, including SELARSDI. In February 2024, the FDA approved SIMLANDI, the first high-concentration, citrate-free interchangeable biosimilar to Humira,which was launched in the U.S. in May 2024. Biologics License Applications for three additional biosimilar candidates developed by Alvotech in partnership with Teva have been accepted for review by the FDA: AVT05, a proposed biosimilar for Simponi and Simponi Aria, and AVT06, a proposed biosimilar for Eylea. Biosimilar User Fee Act goal dates for approval for these BLAs are in Q4 2025.