Alvotech, Teva Get FDA Approval for Stelara Biosimilar Psoriasis Treatment

By Adam L. Cataldo

Alvotech and Teva Pharmaceuticals said the Food and Drug Administration approved the Selarsdi injection for subcutaneous use as a biosimilar to Stelara for the treatment of psoriasis.

The treatment is for patients with moderate to severe plaque psoriasis, adults with active psoriatic arthritis and pediatric patients six years and older.

Selarsdi is expected to be marketed in the U.S. on or after Feb. 21, 2025, following a settlement agreement with Stelara's manufacturer Johnson & Johnson, the companies said Tuesday.

Stelara had almost $7 billion in sales in the U.S. last year. Plaque psoriasis is the most common form of psoriasis, while psoriatic arthritis accounts for approximately 6% of all cases of juvenile arthritis, they said.

Under the strategic partnership between Teva and Alvotech, Teva is responsible for the exclusive commercialization of Selarsdi in the U.S. Alvotech is a biotech company, focused on the development and manufacture of biosimilar medicines based in Iceland. Teva is the U.S. affiliate of Israel-based Teva Pharmaceutical Industries.

Write to Adam Cataldo at adam.cataldo@wsj.com

(END) Dow Jones Newswires

April 16, 2024 18:19 ET (22:19 GMT)

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