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Approval Alert: Samsung Bioepis First Korean Approved Ustekinumab Biosimilar

Apr 12, 2024

On 12 April 2024, Korea Biomedical Review reported that Samsung Bioepis received Korean approval for EpyztekTM(SB17), biosimilar to Janssen’s Stelara® (ustekinumab), for the treatment of plaque psoriasis, psoriatic arthritis, Crohn’s disease and ulcerative colitis.  EpyztekTM is the first ustekinumab biosimilar approved in Korea.

Samsung Bioepis presented Phase 3 results for SB17 at the American Academy of Dermatology Annual Meeting last month, demonstrating equivalence to Stelara® in efficacy and safety.

Under the brand name PyzchivaTM, SB17 was recommended for approval by the EU’s Committee for Medicinal Products for Human Use in February 2024.  Samsung Bioepis also has a BLA for SB17 under review by the FDA, although Samsung cannot commercialise SB17 in the US until 22 February 2025 under a settlement and licence agreement with J&J.  If approved in the US and EU, SB17 will be commercialised by Sandoz pursuant to a deal entered into with Samsung Bioepis in September 2023.

Samsung Bioepis has applied to revoke at least two of Janssen’s Stelara® (ustekinumab) Australian patents in the Australian Federal Court. The trial is provisionally scheduled for November 2024.