Samsung Bioepis Receives First Domestic Approval for Stelara Biosimilar in the '14 Trillion Won Market'

The biosimilar of Stelara, an autoimmune disease treatment with a global market exceeding 14 trillion won annually, has been approved for the first time in Korea.

Samsung Bioepis announced on the 12th that Epiztec, developed as a biosimilar of Stelara, has obtained the first domestic marketing authorization from the Ministry of Food and Drug Safety.

Samsung Bioepis Songdo Office Building Exterior
[Photo by Samsung Bioepis]

Stelara is an autoimmune disease treatment developed by Johnson & Johnson Innovative Medicine. It is used for plaque psoriasis, psoriatic arthritis, Crohn's disease, ulcerative colitis, and more. Last year alone, its global sales reached $10.858 billion (approximately 14 trillion won). With the expiration of its substance patent in September last year, a global competition for biosimilar development ignited. Samsung Bioepis developed Epiztec with plans to export it to North America, Europe, Japan, and other regions, and has now obtained approval in Korea, the first among major countries. In February, the Committee for Medicinal Products for Human Use (CHMP) under the European Medicines Agency (EMA) gave a positive opinion recommending approval, and formal approval is expected as early as this month. The company has also submitted an application for FDA approval in the United States. Upon FDA approval, Samsung Bioepis plans to launch the product in the U.S. early next year in cooperation with Sandoz.

Among domestic pharmaceutical companies, Celltrion and Dong-A ST have completed development of Stelara biosimilars and have applied for approval in major countries. Among foreign pharmaceutical companies, Amgen's Weszelna was the first to receive Stelara biosimilar approval in the U.S. last year. Additionally, Albotech and Pomaidon are in the final stages of development.

Epiztec is the fourth autoimmune disease treatment biosimilar developed by Samsung Bioepis. Following the development of biosimilars for tumor necrosis factor (TNF)-α class autoimmune treatments such as Etoloce, Remaroce, and Adaloce, Samsung Bioepis has expanded its technology pipeline by developing Epiztec, an interleukin inhibitor class biosimilar.

Johnson & Johnson Innovative Medicines' autoimmune disease treatment 'Stelara (active ingredient ustekinumab)'

This approval was based on a Phase 3 clinical trial conducted from July 2021 to November 2022 in eight countries including Korea. In the clinical trial involving 503 patients with plaque psoriasis, Epiztec demonstrated clinical equivalence in efficacy and safety compared to the original drug.

Jung Byung-in, head of the Regulatory Affairs (RA) team at Samsung Bioepis, stated, “By obtaining the first marketing authorization for a Stelara biosimilar in Korea, we can now offer patients more treatment options.”