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Approval Alert: Samsung Bioepis’ Ustekinumab Biosimilar Pyzchiva® (SB17) Approved in Europe

Apr 22, 2024

On 22 April 2024, Samsung Bioepis announced that the European Commission granted marketing authorisation for its Pyzchiva®, biosimilar to Janssen’s Stelara® (ustekinumab).  The approval comes two months after the CHMP adopted a positive opinion for Pyzchiva® for the treatment of plaque psoriasis, psoriatic arthritis, ulcerative colitis and Crohn’s disease.

Pyzchiva® is one of the first ustekinumab biosimilars approved in Europe, following the approval of Alvotech’s and Stada’s Uzpruvo® in January 2024.  Three days after Pyzchiva® was approved, on 25 April 2024, the CMP issued a positive recommendation for the marketing authorisation of Amgen’s ustekinumab biosimilar, Wezenla™. 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.

Earlier this month, Samsung Bioepis received Korean approval for EpyztekTM, the first ustekinumab biosimilar approved in Korea.  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.