Celltrion "Stelara Biosimilar, Launch in Europe"

"Expanding Influence in Europe through Stekima Launch"

Celltrion's biosimilar product of 'Stelara,' named 'Stekima,' has entered the European market.

Celltrion announced on the 4th that it launched 'Stekima' in Germany on the 1st (local time). Celltrion's German subsidiary quickly proceeded with the product launch through a market-tailored strategy, completing the drug price listing and prescription system registration procedures in advance considering the product launch schedule. In particular, even before the launch, they participated in the German Society of Gastroenterology, the largest gastroenterology conference in Germany, to promote Stekima's product competitiveness and focused on increasing brand awareness and prescription preference among local medical professionals.

On the same day, Celltrion also launched Stekima in the Netherlands. Upon launch, Celltrion's Dutch subsidiary secured the bid from IZAAZ, a major pharmaceutical purchasing consortium in the region, proving its direct sales competitiveness. IZAAZ is the largest university hospital group in the Netherlands and is regarded as a key supply channel with influence across the medical field. The bid corresponds to about 27% of the ustekinumab market in the Netherlands, and Stekima is expected to be supplied for about two years starting this month.

Stekima is also scheduled to be launched in mid-month in Finland, a major Nordic country. In Finland, the plan is to quickly lead market capture by continuously communicating with key local healthcare stakeholders even before the launch.

In Ireland, aiming for a launch this month, the local subsidiary plans to participate in the Irish Gastroenterology Winter Meeting held in Dublin from the 21st (local time) to promote the product.

Stekima has been launched in both intravenous (IV) and subcutaneous (SC) formulations, identical to the original drug. The SC formulations are available in 45 mg and 90 mg doses, and the IV formulation in a 130 mg dose, totaling three types. Marketing will actively utilize the fact that different target patient groups, such as Crohn's disease (CD) and psoriasis (PS), correspond to each dosage to create sales synergy.

With this launch of Stekima, Celltrion is expected to secure a stronger market competitiveness in the autoimmune disease treatment field by expanding its portfolio that covers tumor necrosis factor alpha (TNF-α) inhibitors represented by the Remsima product line and 'Yuflyma' (active ingredient: adalimumab) to interleukin (IL) inhibitors, to which Stekima belongs. Celltrion plans to further strengthen its position in Europe by expanding prescriptions based on its diverse product lineup, supply stability, and trust from medical professionals.

Ha Tae-hoon, Head of Celltrion Europe, said, "Celltrion has an integrated structure covering the entire process from drug production to sales, and through this, it has a stable drug supply process in Europe compared to other bio companies, expanding its achievements based on competitive advantages. With 20 subsidiaries established in Europe, we have built strong partnerships centered on Remsima SC with specialists in inflammatory bowel disease (IBD), pharmacists, and hospitals, continuing our success. Through the launch of Stekima, we will further expand Celltrion's influence in Europe and increase trust among medical professionals and patients."

Meanwhile, according to IQVIA, a pharmaceutical market research organization, the global ustekinumab market size last year was estimated at approximately $20.4 billion (about 26.52 trillion KRW). Celltrion plans to rapidly expand the countries where Stekima is launched in Europe by next year to accelerate market capture.