Ustekinumab‑Aekn

Form: Subcutaneous injection (pre-filled syringes, pens); Intravenous Infusion

Strength: Intravenous Infusion(130 mg/26 mL), Subcutaneous injection (pre-filled syringes, pens)

Reference Brands: Stelara(US & EU); Selarsdi- biosimilar of Stelara

Category: Biosimilars

Selardi, a biosimilar of Stelara (ustekinumab), is regulated in the EU and US, supported by dossiers demonstrating biosimilarity, safety, efficacy, and manufacturing quality in compliance with GMP, EMA, and FDA standards. In the US, FDA approval involves comprehensive clinical validation and safety data. In the EU, CE marking certifies conformity with MDR standards. These biosimilars undergo validation, stability testing, and audits, supported by detailed documentation including biosimilarity, clinical trial data, safety profiles, and manufacturing practices. For licensing procedures, approved dossiers, and the latest regulatory updates, visit Pharmatradz. Ensuring compliance guarantees access to high-quality biosimilar therapies supporting affordable treatment for psoriasis, psoriatic arthritis, and Crohn’s disease worldwide.