Celltrion Receives Domestic Approval for 'Stekima,' a Stelara Biosimilar in the 28 Trillion Won Market

Celltrion has succeeded in developing a biosimilar of Stelara, an autoimmune disease treatment with an annual market size of 28 trillion won.

Incheon Songdo Celltrion Plant 2 Overview. / Incheon - Photo by Kim Hyun-min kimhyun81@

On the 13th, Celltrion announced that Stekima (development code CT-P43), developed as a biosimilar of Stelara, received marketing authorization approval from the Korea Ministry of Food and Drug Safety. It took about a year since applying for domestic marketing authorization in June last year, securing all indications of the original drug, including ▲plaque psoriasis ▲psoriatic arthritis ▲Crohn's disease ▲ulcerative colitis.

Stelara is an autoimmune disease treatment developed by Johnson & Johnson (J&J) Innovative Medicine (formerly Janssen). It treats related diseases by inhibiting inflammatory cytokines interleukin (IL)-12 and IL-23. Since the substance patent expired in September last year, global competition for biosimilar development has intensified. According to the pharmaceutical market research firm IQVIA, the market for ustekinumab, the main ingredient of Stelara, was estimated at $20.323 billion (about 28 trillion won) last year. Among domestic pharmaceutical companies, besides Celltrion, Dong-A ST has also completed development and submitted approval applications to major countries. Among foreign pharmaceutical companies, Alvotech’s Silasdi and Amgen’s Weszelana, which have already received approval from the U.S. Food and Drug Administration (FDA), are considered major competitors.

Celltrion expects to further increase its market share in autoimmune disease treatments by expanding its portfolio from existing tumor necrosis factor (TNF)-alpha inhibitor products such as Remsima and Remsima SC (U.S. name: Gyomentra) and Uplima to include IL inhibitor products. Currently, marketing authorization applications have been submitted not only domestically but also in major global countries such as the U.S. and Europe. In particular, in the U.S., since a patent agreement with J&J was already reached last year, there is an expectation to quickly enter the U.S. market after obtaining FDA approval.

A Celltrion official said, “With the acquisition of domestic marketing authorization for Stekima, we have been able to expand our portfolio from the existing TNF inhibitor products to IL inhibitors in the autoimmune disease treatment market,” adding, “We will actively strive to increase our influence in the global ustekinumab market through expanded approvals not only in Korea but also in major global countries.”

This content was produced with the assistance of AI translation services.