FDA Approves Amgen's Biosimilar of J&J's Stelara for Multiple Inflammatory Diseases

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FDA Approves Amgen's Biosimilar of J&J's Stelara for Multiple Inflammatory Diseases
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The U.S. Food and Drug Administration has granted approval to Amgen's biosimilar version of Johnson & Johnson's Stelara for the treatment of various inflammatory diseases. However, the launch of Amgen's treatment is expected to be delayed until 2025 due to a legal settlement between the two companies.

-The U.S. Food and Drug Administration on Tuesday approved Amgen 's biosimilar version of Johnson & Johnson'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.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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