Samsung Bioepis recently reported that it has signed a settlement and license agreement with Johnson & Johnson (“J&J”) in the United States relating to SB17, Samsung Bioepis’s ustekinumab biosimilar to J&J’s STELARA®. If SB17 is approved by the FDA, the license period in the United States will begin on February 22, 2025.
This settlement follows prior J&J ustekinumab settlements with: (1) Amgen, pursuant to which Amgen can market its ustekinumab biosimilar (ABP 654), in the United States no later than January 1, 2025, subject to regulatory approval; (2) Alvotech and Teva, pursuant to which they can market their ustekinumab biosimilar (AVT04) in the United States no later than February 21, 2025, subject to regulatory approval; (3) Formycon and Fresenius Kabi regarding their ustekinumab biosimiar (FYB202), for which no entry date is publicly available; and (4) Celltrion, pursuant to which Celltrion can market its ustekinumab biosimilar (CT-P43), in the United States no later than March 7, 2025, subject to regulatory approval.
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