Product/Composition:- | Belimumab prefilled syringe |
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Strength:- | 200 mg/ten 1 mL for SQ; 10 mg/mL for IV |
Form:- | Subcutaneous (SC) and intravenous (IV) Prefilled syringe |
Reference Brands:- | Benlysta(US & EU) |
MOQ | As per the manufacturer batch size |
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Belimumab is a monoclonal antibody that inhibits BLyS, a cytokine vital for B-cell survival. It reduces abnormal B-cell activity, autoantibody production, and inflammation in systemic lupus erythematosus (SLE). Benefits include decreased disease activity, fewer flares, improved quality of life, and targeted immune modulation with manageable side effects.
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.