Amgen Settles Patent Lawsuit Over Biosimilar of Stelara

(Reuters) – Johnson & Johnson has settled its lawsuit over Amgen Inc’s proposed biosimilar version of J&J’s top-selling treatment Stelara for psoriasis and other autoimmune conditions, according to a filing in Delaware federal court.

Amgen said in a statement on Tuesday that the settlement terms are confidential, but it will allow the company to sell its biosimilar of Stelara “no later than January 1st, 2025.”

A J&J spokesperson said the company will “continue to defend the intellectual property associated with our medicines to protect our ability to innovate and develop life-changing therapies for patients.”

Stelara, which is also approved to treat ulcerative colitis and Crohn’s disease and other conditions, had sales of more than $9.7 billion last year.

Stelara is a biologic drug, meaning it is derived from living cells and cannot be exactly duplicated. A 2009 law allows companies to make biosimilar versions of complex biologic drugs that can be substituted for them, much like cheaper generic versions of conventional drugs, which are exact copies of the branded medicines.

J&J told the court in its lawsuit last year that the U.S. Food and Drug Administration could approve Amgen’s biosimilar in the second or third quarter of 2023.

(Reporting by Blake Brittain in Washington; Editing by David Bario and Bill Berkrot)

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