US pharmaceutical giant Johnson & Johnson (J&J; NYSE: JNJ) has entered into its latest settlement agreement with Fresenius Kabi and Formycon AG, granting the companies a license to launch their biosimilar version of ustekinumab, FYB202, no later than April 15, 2025. This marks the third agreement signed by J&J with companies developing biosimilars for its auto-immune disease blockbuster Stelara (ustekinumab).
J&J’s Strategy with Biosimilar Developers
The deal follows similar agreements signed in May with Amgen, allowing for a launch in January 2025, and with Teva and Alvotech, permitting their biosimilar to launch no later than February 25, 2025. All license deals are subject to the drug firms securing US FDA approvals for their respective products. Stelara, a human monoclonal antibody (mAb) targeting interleukin-12 and interleukin-23, is approved to treat immune-mediated disorders such as moderate-to-severe plaque psoriasis, Crohn’s disease, ulcerative colitis, and active psoriatic arthritis.
Stelara’s Market Performance and Patent Expirations
J&J reported total sales for the molecule at USD 9.7 billion in 2022, with a 6% year-on-year growth, accounting for 10% of J&J’s total revenues. The patents protecting Stelara in the US are set to begin expiring from September 2023 onwards. Licensing agreements with biosimilar developers allow J&J to mitigate early biosimilar challenges and reduce the potential costs of expensive court battles.
Formycon’s Specialized Focus on Biosimilars
Formycon, a company with a specialist focus on biosimilar development, signed a deal with Fresenius Kabi in February 2023 to provide global commercialization support for their ustekinumab molecule. Formycon’s Chief Business Officer, Nicola Mikulcik, noted that the expectation is for a Biologics License Application (BLA) to be filed for the biosimilar later this year, allowing for a launch within the agreed timeframe.-Fineline Info & Tech
