Celltrion announced on the 13th that it has launched its autoimmune disease treatment drug "Steqeyma®" (active ingredient ustekinumab) in the United States, the world's largest pharmaceutical market.
Steqeyma is a biosimilar (biopharmaceutical generic) of Johnson & Johnson's Stelara (active ingredient ustekinumab) in the United States. It received approval from the U.S. Food and Drug Administration (FDA) in December of last year for all the diseases covered by Stelara, including plaque psoriasis (PsO), psoriatic arthritis (PsA), Crohn's disease (CD), and ulcerative colitis (UC).
Steqeyma is available in both intravenous (IV) and subcutaneous (SC) formulations, similar to Stelara, allowing for customized prescriptions based on the patient's condition and product convenience.
Celltrion launched Steqeyma as a low wholesale acquisition cost (Low WAC) version, discounted by 85% from the original product's wholesale price (WAC). The Low WAC version can apply a relatively low rebate rate in the highly rebated U.S. private insurance market, enhancing its profitability. This pricing strategy is considered effective in meeting the diverse demand of not only large pharmacy benefit managers (PBMs) but also uninsured patients and smaller PBMs with lower bargaining power.
Similar to the products recently launched by Celltrion in the U.S., Steqeyma will be sold through the direct sales system of Celltrion's U.S. corporation. The strategy is to leverage the established direct sales distribution network by actively engaging with various stakeholder groups, including PBMs, insurance companies, prescribing physicians, and patient advocacy groups, to quickly gain a competitive advantage.
Celltrion is currently rapidly negotiating with PBMs to secure an early foothold for Steqeyma in the U.S. market. Discussions are ongoing for Steqeyma's inclusion in prescription drug lists with major PBMs, including the top three PBMs in the U.S., and contracts are nearing completion with some.
Kim Bon-jung, CEO of Celltrion's U.S. operation, noted, "From the early launch of Steqeyma, we plan to implement an aggressive marketing strategy to secure coverage in the U.S. ustekinumab market quickly. This year, we expect strong growth for Celltrion's products, from the existing Jimventra and Yuflyma to the newly launched Steqeyma, which will further solidify our position as a leader in autoimmune disease treatments in the world's largest pharmaceutical market, the United States."