Ustekinumab‑Aauz

Form: Subcutaneous injection, Intravenous infusion

Strength: 45 mg or 90 mg

Reference Brands: Stelara(US & EU); Otulfi (ustekinumab-srlf) is a biosimilar of Stelara

Category: Biosimilars

Ustekinumab-aauz is regulated in the EU and US, supported by dossiers demonstrating safety, efficacy, and manufacturing quality compliant with GMP and MDR standards. In the US, FDA approval requires comprehensive clinical trial data and safety validation. In the EU, CE marking certifies conformity with MDR. These products undergo validation, stability testing, and audits, with detailed documentation including safety profiles, clinical efficacy data, and manufacturing practices. For licensing procedures, approved dossiers, and the latest regulatory updates, visit Pharmatradz. Ensuring compliance guarantees access to safe, effective biologic therapies globally, supporting management of psoriasis, psoriatic arthritis, and Crohn’s disease for optimal patient outcomes.