The U.S. Food and Drug Administration (FDA) has approved Teva Pharmaceutical Industries Ltd ( TEVA ). and Alvotech’s Selarsdi (ustekinumab-aekn) injection as interchangeable with the reference biologic Johnson & Johnson’s Stelara (ustekinumab).

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.

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“Teva’s recent launch of two biosimilars – SELARSDI and EPYSQLI – coupled with a rich pipeline of assets expected to launch over the next few years, position Teva to establish a strong leadership position in the growing landscape of biosimilars and to drive growth for the company as it embarks on the next phase of its strategy,” said Thomas Rainey, senior vice president, U.S. Biosimilars at Teva.

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.

Alvotech ( ALVO ) 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 ( ALVO ) entered into a strategic partnership to exclusively commercialize five Alvotech ( ALVO ) biosimilar product candidates. In July 2023, the partnership was extended to include two additional biosimilars and new presentations of two previously partnered products.

Alvotech ( ALVO ) manages development and manufacturing, while Teva is responsible for exclusive commercialization in the U.S., leveraging its experience and extensive sales and marketing infrastructure.

Two biosimilars developed under the Teva – Alvotech ( ALVO ) partnership have been granted FDA approval with interchangeability, including Selarsdi. In February 2024, the FDA approved Simlandi (adalimumab-ryvk), the first high-concentration, a citrate-free interchangeable biosimilar to AbbVie Inc’s Humira (adaliumumab), which was launched in the U.S. in May 2024.

Biologics License Applications (BLAs) for three additional biosimilar candidates developed by Alvotech ( ALVO ) in partnership with Teva have been accepted for review by the FDA:

AVT05, a proposed biosimilar for Johnson & Johnson’s Simponi (golimumab) and Simponi Aria (golimumab).

AVT06, a proposed biosimilar for Regeneron Pharmaceuticals Inc’s Eylea (aflibercept).

Biosimilar User Fee Act (BsUFA) goal dates for approval for these BLAs are in Q4 2025.

Price Action: TEVA stock is up 2.10% at $16.53 and ALVO stock is up 0.67% at $8.22 at the last on check Monday.

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