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Teva Pharma and Alvotech launch biosimilar to J&J's Stelara in US

Teva Pharma and Alvotech launch biosimilar to J&J's Stelara in US

Reuters21-02-2025
Companies
Feb 21 (Reuters) - Teva Pharmaceuticals (TEVA.TA), opens new tab and Alvotech (ALVO.O), opens new tab said on Friday they have launched a biosimilar to Johnson & Johnson's (JNJ.N), opens new tab autoimmune drug Stelara in the United States, the second in a wave of near-copies of the blockbuster treatment.
J&J over the past two years has signed settlement agreements with several companies to delay the US launches of Stelara, which has been its top-selling drug since 2019. The first biosimilar, Amgen's (AMGN.O), opens new tab Wezlana, was launched in January this year.
Biocon Biologics (BIOC.NS), opens new tab is set to launch its version of the drug sometime this month, while Fresenius Kabi (FRES.M3), opens new tab is expected to follow with its own launch in April.
Teva and Alvotech's Selarsdi, like Stelara, is approved for the treatment of moderate to severe plaque psoriasis, active psoriatic arthritis, and moderately to severely active Crohn's disease and ulcerative colitis.
Stelara brought in revenue of $10.36 billion for J&J, making up more than 18% of the drugmaker's total drug sales of $56.96 billion for 2024.
The U.S. Food and Drug Administration has allowed the use of Selarsdi as an "interchangeable" substitute only after April 30, when the exclusive rights for Amgen's Wezlana, expire.
Shares of Teva Pharma rose 2.7% in premarket trading, while Alvotech's saw a 3% increase.
Selarsdi has been launched in Canada as Jamteki, in Europe as Uzpruvo, and in Japan as Ustekinumab BS.
In August 2020, Teva agreed to exclusively market five of Alvotech's biosimilar products in the United States. The companies extended their partnership in 2023 to include two additional biosimilars.
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