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

2023.10.31 20:03


© 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

(Reuters) – The U.S. Food and Drug Administration on Tuesday approved Amgen (NASDAQ:)’s biosimilar version of Johnson & Johnson (NYSE:)’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.

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