Celltrion launches Stelara and Xolair biosimilars in Australia, eyes 2026 follow-ons

Celltrion has expanded its Oceania footprint with the Australian debut of Steqeyma (ustekinumab-stba), a biosimilar to Janssen’s Stelara for autoimmune diseases, and Omlyclo (omalizumab-igec), a biosimilar to Roche/Novartis’ Xolair for allergic conditions. 

The launches, announced Thursday, are being carried out through a dual strategy: Celltrion’s local subsidiary will target hospital tenders while partner Arrotex Pharmaceuticals drives pharmacy sales, aligning with Australia’s split distribution system.

The move builds on a favorable policy environment. Australia has promoted biosimilar adoption with simplified approvals and supportive reimbursement, helping Celltrion’s existing lineup notch strong gains, the company said in its release.

According to IQVIA data, the Remsima franchise -- biosimilars of Johnson & Johnson’s Remicade (infliximab) -- held 57 percent of the Australian market in the first quarter of 2025, with Remsima SC alone at 27 percent. 

Oncology biosimilars are also performing well, with Herzuma (trastuzumab-pkrb), referencing Roche’s Herceptin, at 56 percent and Truxima (rituximab-abbs), referencing Roche’s Rituxan, at 17 percent.

In New Zealand, Herzuma has dominated trastuzumab tenders since its 2022 launch, holding nearly 100 percent market share through early 2025. Celltrion added Vegzelma (bevacizumab-adcd), a biosimilar to Roche’s Avastin, in March to deepen its oncology presence.

The company said it plans to launch biosimilars of denosumab (Amgen’s Prolia/Xgeva) and tocilizumab (Roche’s Actemra) in Oceania in 2026, banking on brand familiarity to speed uptake.