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14 June 2023AmericasMuireann Bolger

J&J agrees Stelara deals with generics

Deal thought to be aimed at helping pharma giant attain sales target as patents start to expire | Israeli drugmaker will join with Icelandic firm to unveil a copycat version of blockbuster treatment by 2025.

J&J has paved the way for generic drug makers  Alvotech and  Teva to introduce a biosimilar version of  Stelara (ustekinumab), which is used to treat Crohn’s disease and other illnesses.

The pharma giant signed a settlement agreement this week, granting the pair a licence to produce the copycat treatment,  AVT04, on the understanding that it must be launched no later than February 21, 2025.

The deal comes in the wake of J&J’s licensing deal with  Amgen, which enables the latter to launch its copycat of the biologic no later than January 1, 2025.

In 2022, the biologic generated more than $9.7 billion in revenue for J&J, representing a 6% jump from its sales from a year earlier.

As Stelara’s patents are due to expire by the end of this year, J&J’s Stelara settlements are thought to be an attempt to help it attain a $57 billion sales goal by 2025, according to  Reuters.

Stelara features the IL-12/23 inhibitor, which is approved for a range of inflammatory diseases including psoriasis, psoriatic arthritis, Crohn’s disease and ulcerative colitis.

Israel-based Teva teamed up with Icelandic firm Alvotech on AVT04 in 2020 as part of a strategic partnership that covers five biosimilars in the US.

Teva is responsible for marketing activities, whereas Alvotech controls areas relating to the development, regulation and manufacturing of the drugs.
While AVT04 has yet to be approved by the  US Food and Drug Administration; its Biologics License Application was accepted at the start of this year.

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