On 14 January 2026, Samsung Bioepis announced that Korea’s Ministry of Food and Drug Safety has approved a pre-filled pen formulation (PFP) of Epyztek®, biosimilar to J&J/Janssen’s Stelara® (ustekinumab). According to Samsung Bioepis, this is the first PFP presentation of ustekinumab to be approved in Korea.
Epyztek® (SB17) was the first ustekinumab biosimilar approved in South Korea in April 2024. SB17 was approved in Europe in April 2024 as Pyzchiva® and a Pyzchiva® autoinjector was launched in May 2025 as the first commercially available biosimilar ustekinumab pre-filled pen in Europe. In the US, Pyzchiva® was approved in July 2024 and launched in February 2025, in PFS and vial forms. Under a development and commercialisation agreement with Sandoz entered in September 2023, Sandoz has the right to commercialise Pyzchiva® in Europe, Switzerland, the UK, the US and Brazil.
The EMA’s CHMP adopted a positive opinion for Celltrion’s PFP/autoinjector presentation of its ustekinumab biosimilars, Steqeyma® and Qoyvolma®, in December 2025. Celltrion’s PFP presentation of the product was approved in Australia in the same month.