Samsung Bioepis secures 1st approval in Korea for Stelara biosimilar

Samsung Bioepis has achieved a significant milestone by obtaining the first domestic approval for a biosimilar referencing Janssen's Stelara, Epyztek (ingredient: ustekinumab), on Thursday.

Stelara, originally developed by Janssen, is utilized in the treatment of plaque psoriasis, psoriatic arthritis, Crohn's disease, and ulcerative colitis. It functions by inhibiting the activity of interleukin (IL)-12/23, a cytokine involved in autoimmune inflammation and is one of the highest-grossing biopharmaceuticals in the world, with IQVIA data showing that the treatment recorded $17.7 billion in sales in 2022.

Epyztek represents the fourth autoimmune treatment developed by Samsung Bioepis, following successful launches of biosimilars such as Etoloce (Enbrel biosimilar), Remaloce (Remicade biosimilar), and Adalloce (Humira biosimilar). The approval of Epyztek allows Samsung Bioepis to expand its portfolio to include an interleukin inhibitor, further enhancing its offerings for autoimmune disease treatments.

"Receiving the first domestic approval for a Stelara biosimilar in Korea allows us to offer more treatment options to patients, which is a significant step forward,” Samsung Bioepis Regulatory Affairs Vice President Jung Byung-in said.

Meanwhile, Samsung Bioepis conducted a phase 3 clinical trial involving 503 patients with plaque psoriasis across eight countries, including Korea, from July 2021 to Nov. 2022. The study confirmed the clinical equivalence in efficacy and safety of Epyztek compared to the original medication, Stelara.

The company also received a positive opinion for Epyztek from the Committee for Medicinal Products for Human Use (CHMP) under the European Medicines Agency (EMA) in February. The biosimilar is set to marketed under the name Pyzchivatm in Europe.