Ustekinumab (Auub)

Form: Injectable solution (subcutaneous administration)

Strength: 45 mg & 90 mg

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

Category: Biosimilars

Ustekinumab (AUUB) 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 involves rigorous clinical validation, safety assessments, and GMP compliance. In the EU, CE marking certifies conformity with MDR regulations. The product undergoes validation, stability testing, and audits, with comprehensive documentation including safety profiles, clinical data, and manufacturing practices. For licensing procedures, approved dossiers, and latest regulatory updates, visit Pharmatradz. Ensuring compliance guarantees access to safe, effective biologic therapies for psoriasis, psoriatic arthritis, and Crohn's disease worldwide, supporting healthcare and patient management effectively.