Celltrion has introduced Steqeyma, its biosimilar to Stelara, in the U.S. at an 85 percent lower wholesale acquisition cost (WAC) than the reference drug.

By setting a lower WAC version, the company aims to enhance profitability in the U.S. private insurance market, where high rebate rates often erode margins, while also appealing to major pharmacy benefit managers (PBMs) and uninsured patients.

Celltrion received approval for Steqeyma from the FDA in last December for all indications of the reference drug.

Stelara, developed by Johnson and Johnson Innovative Medicine, treats various inflammatory diseases including plaque psoriasis, psoriatic arthritis, Crohn's disease, and ulcerative colitis. Stelara is one of the top-grossing biopharmaceuticals globally, with sales reaching $20.3 billion in 2023, according to IQVIA.

Steqeyma is available in both intravenous (IV) and subcutaneous (SC) formulations, mirroring the original product. The dual formulation offers flexibility in prescribing, allowing physicians to tailor treatments based on patient conditions and convenience.

Following the model of its recent U.S. launches, Celltrion will distribute Steqeyma through its direct sales network established by its American subsidiary. Leveraging its existing network developed through the sales of Zymfentra (ingredient: infliximab) and Yuflyma (ingredient: adalimumab), the company aims to swiftly secure a competitive advantage by engaging PBMs, insurers, prescribing physicians, and patient advocacy groups.

Celltrion has been actively negotiating with PBMs to secure early market access for Steqeyma. Discussions are underway with major PBMs, including the top three in the U.S., with some deals nearing finalization.

With the launch of Steqeyma, Celltrion now has four inflammatory bowel disease (IBD) treatments available in the U.S.

The company believes that the diverse product portfolio will enable physicians to switch treatments efficiently when resistance develops, ensuring continuity in patient care and facilitating bundling strategies which can enhance negotiations with insurers and PBMs.

“We plan to deploy aggressive marketing strategies from the outset to rapidly secure market coverage for Steqeyma in the U.S.,” Celltrion USA CEO Kim Bon-joong said. “ With the strong growth trajectory of Zymfentra, Yuflyma, and now Steqeyma, we are solidifying Celltrion’s position as a leading player in the U.S. autoimmune disease treatment market.”