Celltrion launches Stelara biosimilar in US
Steqeyma, a biosimilar of Johnson & Johnson's blockbuster drug Stelara, received full-label approval from the US Food and Drug Administration last December for plaque psoriasis, psoriatic arthritis, Crohn's disease and ulcerative colitis. The treatment is available in intravenous and subcutaneous formulations, allowing for flexible dosing options based on patient needs.
Celltrion is launching Steqeyma at an 85 percent lower wholesale acquisition cost, or WAC, than Stelara. The company said this pricing strategy is expected to enhance profitability in the US insurance market, where high rebate rates are common.
The company also aims to attract major pharmacy benefit managers and uninsured patients under the lower WAC version with reduced rebates. Celltrion is currently under negotiation with leading PBMs, including the three largest in the US, with some contracts nearing completion.
To accelerate early market penetration, Celltrion is leveraging its direct sales distribution network, which it previously built for its biosimilars, including Zymfentra and Yuflyma.
'We are implementing an aggressive marketing strategy from the very start to secure early market share,' said Kim Bon-joong, CEO of Celltrion USA. 'With our expanding product lineup, we expect strong growth and aim to solidify our position as a leading provider of autoimmune disease treatments in the world's largest pharmaceutical market.'
According to pharmaceutical market research firm IQVIA, the global ustekinumab market was estimated at approximately $20.4 billion in 2023, with the US accounting for 77 percent of sales at $15.6 billion.
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