Celltrion Launches Autoimmune Disease Treatment 'Stekima' in the US

Negotiations Underway for Listing Contracts with Major Companies Including Top 3 U.S. PBMs
'Low WAC' Launched at 85% Discount Compared to Original

Celltrion announced on the 12th (local time) that it has launched the autoimmune disease treatment 'Stekima' in the United States.

Stekima. Celltrion

Stekima is a biosimilar product developed by Celltrion. In December last year, it received approval from the U.S. Food and Drug Administration (FDA) for the full label indications of the original product 'Stelara,' including plaque psoriasis (PsO), psoriatic arthritis (PsA), Crohn's disease (CD), and ulcerative colitis (UC). Stekima is launched in both intravenous (IV) and subcutaneous (SC) formulations, identical to the original, allowing for customized prescriptions that comprehensively consider patient condition and product convenience.

Celltrion launched Stekima at a low wholesale acquisition cost (Low WAC) version, discounted by 85% from the original product's wholesale acquisition cost (WAC). The Low WAC version can apply relatively lower rebate rates in the U.S. private insurance market, where rebate levels are high, resulting in higher profitability. This pricing strategy is also evaluated as capable of meeting diverse demands, including large pharmacy benefit managers (PBMs), uninsured patients, and small to medium-sized PBMs with low rebate negotiation power.

Like other products recently launched in the U.S., Stekima is sold through Celltrion's U.S. subsidiary's direct sales system. Based on the direct sales distribution network built through products such as Jimpendra and Uplima, the strategy is to quickly gain a competitive edge by actively utilizing human networks with various stakeholders, including PBMs, insurers, prescribing specialists, and patient associations.

Celltrion is rapidly negotiating with PBMs aiming for early market dominance of Stekima in the U.S. Discussions are underway with large PBMs, including the top three PBMs in the U.S., for listing Stekima on their formularies, and some are in the final stages of contract signing.

The newly launched Stekima is an interleukin (IL) inhibitor and is expected to contribute to expanding treatment options for autoimmune diseases alongside existing TNF-α inhibitors such as Remsima, Jimpendra, and Uplima. With the launch of Stekima, Celltrion will have a total of four IBD products launched in the U.S., which is expected to further increase the prescription preference for Celltrion products overall. Considering physicians' perspectives, who need to prescribe optimal medications to patients and consider switching treatments when resistance develops, a diverse lineup of treatments can serve as a core competitive advantage by simultaneously guaranteeing prescription options and treatment continuity for patients. As the product portfolio diversifies, more flexible sales strategies such as bundling marketing by product groups can be implemented, further strengthening negotiation power with insurers and PBMs.

Kim Bonjung, CEO of Celltrion's U.S. subsidiary, said, "From the early stages of Stekima's launch, we plan to secure U.S. ustekinumab market coverage early through aggressive marketing strategies. This year, strong growth is expected for Celltrion products, from existing Jimpendra and Uplima to the newly launched Stekima, enabling us to further solidify our status as a leading autoimmune disease treatment company in the world's largest pharmaceutical market, the United States."