J&J's Stelara settlement streak rolls on with Fresenius Kabi, Formycon deal

By inking a third Stelara patent settlement, Johnson & Johnson is getting more clarity around the forthcoming loss of exclusivity for its top product by sales.

J&J has signed its latest Stelara patent settlement with Fresenius Kabi and Formycon, granting the biosimilar partners a U.S. license date for their drug beginning "no later than April 15, 2025," according to a Monday release.

If the partners are able to secure regulatory approval for their Stelara biosimilar by that date, they'll be clear to launch under the new settlement agreement. 

The agreement follows J&J's first Stelara patent settlement with Amgen back in May. Under that deal, Amgen has a U.S. license to launch its biosimilar "no later than January 1st, 2025," a spokesperson told Reuters at the time.

Then, in June, J&J inked another deal with Teva and Alvotech. Under that deal, those biosim partners can market their biosim no later than Feb. 21, 2025.

As for Fresenius Kabi and Formycon, the partners are "on track" to submit their FDA application this year, Formycon Chief Business Officer Nicola Mikulcik said in a statement. Under that timeline, they should be ready to go by their licensing date barring any regulatory setbacks.

Fresenius Kabi signed up to commercialize Formycon's Stelara biosimilar in a February 2023 global licensing agreement

J&J's Stelara pulled in $9.72 billion in sales last year, making it one of the top targets for biosimilar makers in the coming years.

Meanwhile, AbbVie's megablockbuster Humira tumbled over the patent cliff earlier this year, with Amgen's biosimilar Amjevita getting a head start over other biosimilar rivals. But in the first half of the year, the Amgen product generated just $70 million in sales. About a month ago, a handful of other biosimilar players launched in the U.S.