Celltrion Launches Autoimmune Drug Aptozma in U.S., Targets Competitive Pricing and Market Expansion

[medi K / HEALTH IN NEWS] Celltrion, a South Korean biopharmaceutical company, has launched its autoimmune disease treatment Aptozma (tocilizumab biosimilar) in the United States, marking a significant milestone in its global market expansion strategy. The drug, initially introduced as an intravenous (IV) formulation, will soon be followed by a subcutaneous (SC) version, expanding patient accessibility and treatment options.

Aptozma is priced approximately 35% lower than its reference product at wholesale acquisition cost (WAC), a strategic decision by Celltrion to balance affordability with commercial viability. The biosimilar functions by inhibiting interleukin-6 (IL-6), a pro-inflammatory cytokine that drives autoimmune inflammation, and has received U.S. Food and Drug Administration (FDA) approval for the same indications as the originator drug, including rheumatoid arthritis, giant cell arteritis, juvenile idiopathic arthritis, and coronavirus disease 2019 (COVID-19).

A notable early achievement is Aptozma's inclusion as a preferred agent on the formulary of Blue Cross Blue Shield (BCBS) of Minnesota, which is part of a major U.S. insurance network covering over 100 million members nationwide. This preferred status signals strong potential for broader adoption across additional BCBS plans, significantly enhancing the drug's market penetration and patient access.



Celltrion is actively pursuing negotiations with major U.S. pharmacy benefit managers (PBMs) to further secure comprehensive insurance coverage. The company is also leveraging its existing autoimmune disease drug portfolio—including infliximab biosimilar (Zymfentra), adalimumab biosimilar (Yuflyma), and ustekinumab biosimilar (Steqeyma)—to create cross-promotional marketing synergies and strengthen its competitive position in the U.S. biosimilar marketplace.

To support Aptozma's market entry and commercialization, Celltrion is expanding its U.S.-based sales force, particularly targeting rheumatology specialists and healthcare providers managing autoimmune conditions. The forthcoming SC formulation is anticipated to broaden distribution channels beyond hospital settings, enabling availability in retail and specialty pharmacies, thus offering more flexible and personalized treatment options for patients.

Thomas Nusbickel, Chief Commercial Officer of Celltrion USA, emphasized the company's direct-to-market expertise and strategic vision: "Drawing on our experience with previous product launches, we are focused on rapidly establishing Aptozma's presence in the U.S. market. Our goal is to enhance treatment accessibility while providing meaningful therapeutic alternatives for healthcare providers and their patients."

The originator drug, Actemra (tocilizumab), generated global sales of approximately $3.2 billion in the previous year, with more than half derived from the U.S. market alone. Celltrion's competitive pricing strategy and systematic market expansion efforts signal an ambitious initiative to capture a substantial share of this high-value therapeutic segment while improving patient access to critical autoimmune treatments.

Kim Kuk Ju / press@themedik.kr

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