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U.S. FDA approves Amgen's biosimilar version of J&J's psoriasis drug

06 15, 2025

U.S. FDA approves Amgen's biosimilar version of J&J's psoriasis drug © Reuters. FILE PHOTO: An Amgen sign is seen at the company's office in South San Francisco, California October 21, 2013. REUTERS/Robert Galbraith/File Photo   AMGN -2.85% Add to/Remove from Watchlist Add to Watchlist Add Position

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(Reuters) - The U.S. Food and Drug Administration on Tuesday approved Amgen (NASDAQ:AMGN)'s biosimilar version of Johnson & Johnson (NYSE:JNJ)'s blockbuster psoriasis treatment, Stelara, for multiple inflammatory diseases.


Despite the FDA approval, Amgen's treatment is expected to be launched in 2025 as part of a legal settlement between the two companies earlier this year to delay the entry of the therapy.



Biosimilars are close copies of complex biological drugs.


Stelara, introduced in 2009, has been J&J's top-selling drug since 2019, with sales reaching $9.7 billion in 2022.


U.S. FDA approves Amgen's biosimilar version of J&J's psoriasis drug  

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