FDA Approves Alvotech and Teva Biosimilar SELARSDI™

The U.S. Food and Drug Administration (FDA) has approved SELARSDI™ (ustekinumab-aekn) for subcutaneous injection, a biosimilar to Stelara®. The drug is indicated for moderate to severe plaque psoriasis and active psoriatic arthritis in adults and pediatric patients aged six years and older.

SELARSDI was developed and is manufactured by Alvotech. Teva Pharmaceuticals, the U.S. affiliate of Teva Pharmaceutical Industries Ltd., is responsible for its exclusive commercialization in the United States under a strategic partnership. This marks the second biosimilar approval for the Alvotech-Teva collaboration. Following a settlement agreement with Johnson & Johnson, the manufacturer of Stelara, SELARSDI is expected to be marketed in the U.S. on or after February 21, 2025.

Sales of the reference product, Stelara, reached nearly $7 billion in the U.S. in 2023. The introduction of a biosimilar is anticipated to provide cost savings for the healthcare system and expand treatment options for patients. Alvotech stated that SELARSDI was developed using the same cell line and continuous perfusion process as the reference product.

The FDA approval was based on a comprehensive review of analytical and clinical data. This included a 52-week randomized, double-blind, multicenter study comparing the efficacy, safety, and immunogenicity of SELARSDI to Stelara in patients with moderate to severe chronic plaque psoriasis. The Alvotech-Teva partnership, established in 2020, focuses on commercializing biosimilars in the U.S. market.