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The FDA has approved Alvotech’s biosimilar of Johnson & Johnson’s (NYSE:JNJ) top-selling drug Stelara.
The biosimilar, called Selarsdi, will be marketed in the US by Alvotech partner Teva Pharmaceuticals (NYSE:TEVA) following a settlement with J&J. Teva intends to launch the product on or after Feb. 21, 2025, according to the companies.
The FDA approved Selarsdi for the treatment of moderate-to-severe plaque psoriasis and active psoriatic arthritis in adults and children aged six years and older.
Selarsdi is the second biosimilar to receive approval under a partnership between Iceland’s Alvotech and Israel’s Teva.
Stelara is J&J’s best-selling drug, generating sales of around $10.9B in 2023.
