Belimumab prefilled syringe

Form: Subcutaneous (SC) and intravenous (IV) Prefilled syringe

Strength: 200 mg/ten 1 mL for SQ; 10 mg/mL for IV

Reference Brands: Benlysta(US & EU)

Category: Immune Disorder

Belimumab, marketed as Benlysta, is approved in the US by the FDA and in the EU via EMA for treating active systemic lupus erythematosus (SLE). Regulatory approval requires a comprehensive dossier including clinical trial data, safety profiles, manufacturing processes, and pharmacovigilance plans. In the US, the FDA reviews detailed clinical and manufacturing information, while the EMA ensures regional compliance with safety and quality standards. For guidance on dossier preparation, regulatory pathways, and market access, visit PharmaTradz. Ensuring thorough regulatory compliance is essential for the safe, effective, and timely approval of belimumab prefilled syringe products worldwide, supporting advanced autoimmune disease management.