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

by Reuters

(Reuters) – 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.

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.

(Reporting by Pratik Jain in Bengaluru; Editing by Anil D’Silva)

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