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Approval Alert: Samsung Bioepis’ Ustekinumab Biosimilar Approved in US

Jul 1, 2024

On 1 July 2024, Samsung Bioepis announced that the FDA approved its Pyzchiva® (SB17), biosimilar to Janssen’s Stelara® (ustekinumab) for multiple indications, including moderate to severe plaque psoriasis, active psoriatic arthritis and moderately to severely active Crohn’s disease and ulcerative colitis.  The FDA has provisionally determined Pyzchiva® as interchangeable with Stelara®. 

Samsung Bioepis is licensed to launch Pyzchiva® in the US in Q2 2025, under a settlement and licence agreement with J&J entered into in November 2023 resolving pending US litigation between the companies. 

Samsung Bioepis’ SB17 was approved in April 2024 in Europe (as Pyzchiva®) and Korea (as EpyztekTM).  Pyzchiva® will be commercialised by Sandoz in EEA, Switzerland, UK, US and Canada pursuant to a deal entered into in September 2023 between Sandoz and Samsung Bioepis.

A number of ustekinumab biosimilars are currently approved in Europe, including Alvotech and STADA’s Uzpruvo® (January 2024). Amgen’s Wezenla® received a positive CHMP recommendation in April 2024.