Ustekinumab‑Srlf

Form: Subcutaneous injection, Intravenous infusion

Strength: 45 mg or 90 mg doses

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

Category: Biosimilars

Ustekinumab (Ustekinumab-srlf) is regulated in the EU and US, supported by dossiers demonstrating safety, efficacy, and manufacturing quality compliant with GMP standards. In the US, FDA approval involves extensive clinical validation and safety assessments. In the EU, CE marking certifies conformity with MDR standards. These products undergo validation, stability testing, and audits, with comprehensive documentation including safety profiles, clinical 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 worldwide, supporting optimal management of psoriasis, psoriatic arthritis, and Crohn’s disease.