Ustekinumab biosimilars

Fully human IgG1 kappa monoclonal antibody of about 148 kDa. The reference product is produced in a murine myeloma (Sp2/0) cell line; several biosimilars are produced in Chinese hamster ovary cells, which changes the glycan profile and has to be shown not to matter.

Binds the p40 protein subunit shared by interleukin-12 and interleukin-23 and prevents them from engaging the IL-12R beta 1 receptor on T cells, NK cells and antigen-presenting cells. Blocking both cytokines suppresses the Th1 and Th17 pathways that drive psoriasis, psoriatic arthritis and inflammatory bowel disease.

Subcutaneous bioavailability about 57%, peak concentrations at about one week, half-life around three weeks (15 to 32 days), so maintenance dosing is every eight or twelve weeks. Clearance is higher in heavier patients, which is why the psoriasis dose steps from 45 mg to 90 mg above 100 kg.

Psoriasis and psoriatic arthritis: 45 mg or 90 mg subcutaneously at weeks 0 and 4, then every 12 weeks. Crohn's disease and ulcerative colitis: a single weight-based intravenous induction dose from the 130 mg/26 mL vial, then 90 mg subcutaneously every 8 weeks. Supplied as 45 mg/0.5 mL and 90 mg/mL pre-filled syringes and pens and the 130 mg intravenous vial.

• Plaque psoriasis (adult and paediatric from 6 years)
• Psoriatic arthritis
• Crohn's disease
• Ulcerative colitis

Anti-drug antibodies occur in roughly 6 to 12% of patients and are associated with lower concentrations and reduced response in a minority. Comparative programmes use analytical similarity, a pharmacokinetic study in healthy volunteers, and a comparative efficacy study in moderate to severe plaque psoriasis with PASI improvement at week 12 as the primary endpoint, with extrapolation to the arthritis and bowel indications.

Stelara was authorised in the EU on 16 January 2009 (EMEA/H/C/000958) and licensed by FDA on 25 September 2009 (BLA 125261), first for psoriasis, then psoriatic arthritis (2013), Crohn's disease (2016) and ulcerative colitis (2019). The first biosimilar, Wezlana, was approved by FDA in October 2023 as interchangeable; US launches began in January 2025 under settlement agreements, and the EU market opened with Uzpruvo in January 2024 after the compound patent expired in July 2024.

Sources: Purple Book (S016), EMA medicines data (S017); settlement and patent dates from company and press reports.

Ustekinumab is the immunology wave that followed adalimumab, compressed into two years: eight FDA products and fourteen EU authorisations between late 2023 and 2025, almost all interchangeable in the US since April 2025. The commercial questions are about the intravenous induction presentation, which not every developer has, and about the psoriasis-to-IBD extrapolation. India has one domestic product, Reliance's UstekiRel, permitted in 2023 and extended to psoriatic arthritis in 2024.