Two More Patent Settlements and Launch Dates for Ustekinumab Biosimilars

In early August, partners Fresenius Kabi and Formycon announced that they had reached an agreement with Johnson & Johnson to launch FYB202, if approved by the FDA, “no later than April 15, 2025.” Later that month, Celltrion finalized its patent agreement for CT-P43, enabling a launch in March 2025. Celltrion had filed its 351(k) application for FDA approval in June 2023.

ManufacturerDrugSettlement Launch Dates (“no later than”)
AmgenABP 654Jan 1, 2025
Alvotech/TevaAVT04Feb 21, 2025
CelltrionCT-P43March 7, 2025
Fresenius Kabi/FormyconFYB202April 15, 2025

The principal patent for the reference product expires next month in the US (and in July 2024 in the EU). It is assumed that these ustekinumab biosimilar launch agreements also end all patent disputes among the parties. It is not known whether royalties are to be paid to Johnson & Johnson based on biosimilar sales, as were included in the AbbVie agreements for Humira®.

Other publicly announced, potential competitors for this interleukin 12/23 biologic include Bio-Thera, Samsung Bioepis, and Biocon, all of which have completed or are finishing their phase 3 studies. Similar to the Humira example, we expect all to eventually sign settlements with Johnson & Johnson prior to launch.    

Curiously, all of the ustekinumab biosimilar launch settlements signed to date include the language “no later than XX, 2023.” This begs the question as to what may pose an opportunity to launch earlier? This occurred when several of the adalimumab biosimilars were able to move their launch dates to July from the third and fourth quarters of 2023.

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