History Repeating: Will US Stelara Settlements Follow Humira’s Lead?

Adalimumab Example Could Provide A Playbook For Settlements Over Ustekinumab Biosimilars

Years before Humira rivals hit the US market in 2023, a series of litigation settlements between biosimilar adalimumab developers and originator AbbVie provided a roadmap for a succession of date-certain launches this year. Now, similar settlements over Stelara between J&J and ustekinumab developers are starting to fall into place for 2025.

Typewriter with typed lines "History Repeats Itself..."
Will Stelara settlements offer a rerun of the Humira deals? • Source: Shutterstock

Until recently, biosimilars industry analysts had predicted that Johnson & Johnson’s immunology blockbuster Stelara (ustekinumab) could face US competition before the end of 2023, with the September expiry of a key patent protecting the top-selling brand.

However, recent developments have now upset those expectations, with a pair of separate settlements over ustekinumab biosimilars suggesting that the industry could be in for a rerun of the Humira (adalimumab) saga that saw multiple competitors individually all settle with originator AbbVie, setting up

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