Celltrion's 'Stekima', a Stelara biosimilar for the 28 trillion KRW market, nears European approval

Celltrion announced on the 1st that on the 27th of last month (local time), the Committee for Medicinal Products for Human Use (CHMP) under the European Medicines Agency (EMA) gave a positive opinion recommending the marketing authorization of Stekima (development code CT-P43), a biosimilar of the autoimmune disease treatment Stelara, for 30 European countries.

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

Stekima received a recommendation for approval in Europe for indications related to autoimmune diseases such as ▲plaque psoriasis ▲psoriatic arthritis ▲Crohn's disease. The CHMP's positive opinion plays a decisive role in the final approval by the European Commission (EC), meaning that the product has passed the critical stage of authorization. Typically, it takes about two months for the EC to grant final approval.

Stekima was already approved by the Korean Ministry of Food and Drug Safety on the 12th of last month. Preparations for detailed procedures for domestic sales have already begun. Following Korea, if final marketing authorization is obtained in Europe, it is expected to accelerate global market penetration. Additionally, it is anticipated that Celltrion can expand its autoimmune disease portfolio, which currently includes TNF-alpha (tumor necrosis factor-alpha) inhibitors such as Jimptetra, Remsima, and Uplima, to include interleukin (IL) inhibitor products as well.

The original drug Stelara is an autoimmune disease treatment developed by Johnson & Johnson (J&J) Innovative Medicine (formerly Janssen). It treats related diseases by inhibiting inflammatory cytokines IL-12 and IL-23. With the expiration of the substance patent in September last year, global competition for biosimilar development has intensified. According to IQVIA, a pharmaceutical market research firm, the market for ustekinumab, the active ingredient of Stelara, was estimated at $20.323 billion (approximately 28 trillion KRW) last year.

A Celltrion official stated, “Following domestic approval, the visibility of Stekima’s marketing authorization approval in Europe is increasing expectations for global penetration of the ustekinumab market,” and added, “We will do our best to smoothly proceed with the remaining approval procedures in major global countries so that Stekima can be introduced to the market as soon as possible.”