Ustekinumab‑Aauz Suppliers & Bulk Manufacturers

Available Forms: Subcutaneous injection, Intravenous infusion

Available Strengths: 45 mg/0.5 mL, 90 mg/mL (SC); 130 mg/26 mL (IV)

Reference Brands: Stelara (reference product, US & EU)

Category: Biosimilars

Ustekinumab-aauz, a biosimilar of ustekinumab in 45 mg and 90 mg subcutaneous syringes with an IV induction vial. Listed for hospitals, tender buyers and importers evaluating biosimilar biologics.

Product Description:

Ustekinumab-aauz is a biosimilar of ustekinumab, an anti-interleukin-12/23 monoclonal antibody. The four-letter suffix follows the US naming convention for biologics: it marks a distinct licensed product with the same active substance. It is made in living cells and shown, through analytical, non-clinical and clinical comparison, to have no clinically meaningful differences from the reference product. It comes as 45 mg and 90 mg subcutaneous prefilled syringes, with an intravenous vial for induction.

Its approved uses follow the reference product, namely plaque psoriasis, psoriatic arthritis, Crohn's disease and ulcerative colitis, though each national label should be checked. Patients stable on the reference product may be switched under specialist oversight. Whether a pharmacist may substitute without the prescriber depends on local law and, in the US, on an interchangeable designation. Clinical cautions match the molecule: tuberculosis screening first, vigilance for serious infection and no live vaccines. Adverse event reports should record the product name and batch number so each biosimilar can be traced.

Sourcing notes. Ask for the biosimilarity package as well as the usual quality file: the comparability exercise, the reference product used and the regulatory decisions already granted. Most regulators expect a CTD dossier with a full quality module plus the comparative data. Storage is refrigerated at 2-8 °C, protected from light and never frozen, so delivery terms must cover the cold chain. Ask for a CoA for every lot, GMP certificates for drug substance and drug product sites, and a CoPP. In tenders, specify the presentation, whether biosimilars are acceptable and any interchangeability requirement.