Second Prospective Ustekinumab Biosimilar Maker Signs Licensing Agreement With J&J

As reported in late May, Amgen settled with Johnson & Johnson to launch its biosimilar version of Stelara® by January 1, 2025. That signaled the beginning of licenses being provided to the other manufacturers, confirmed by an agreement between Alvotech and the reference drug maker.

According to the June 12 press release, Alvotech and its commercialization partner Teva, will be able to launch its biosimilar candidate AVT04 “no later than February 21, 2025.” If this sounds familiar, it should. With 7 potential biosimilar competitors, the sequence of launches could look quite a bit like that originally scheduled for Humira®. In that case, the original launch sequence was supposed to extend throughout 2023, before being condensed largely to January and July 2023.

Other than the launch dates provided in the licensing agreements, no other details have been announced. Typically, these licensing arrangements prevent the reference manufacturer from contesting infringement on the drug’s principal patents, in exchange for a royalty payment.

Alvotech filed for 351(k) approval of this product on January 6, 2023, and an expected Q4 FDA decision may have resulted in a launch in early 2024.

If J&J’s approach closely follows AbbVie’s template for Humira, all of the prospective ustekinumab biosimilar makers will sign licensing agreements, with separate launch dates. However, Amgen’s period of biosimilar exclusivity may be shorter, unless the legal statement “no later than January 1, 2025” does not practically exclude a significantly earlier launch.

No information was available from the other biosimilar manufacturers regarding the status of a licensing arrangement with J&J.   

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