Eculizumab‑Aeeb

Form: Injection for intravenous infusion

Strength: 300 mg/20 mL (IV infusion),

Reference Brands: Soliris, Bkemv- Biosimilar of Soliris, Epysqli- Biosimilar of Soliris

Category: Biosimilars

Biosimilars of Soliris (eculizumab) are regulated in the EU and US, supported by dossiers demonstrating biosimilarity, safety, efficacy, and manufacturing quality in compliance with GMP and MDR standards. In the US, FDA approval requires extensive comparability data, clinical validation, and safety assessments. In the EU, CE marking certifies conformity with MDR regulations. These biosimilars undergo validation, stability testing, and audits, with detailed documentation including biosimilarity, clinical trial data, safety profiles, and manufacturing practices. For licensing procedures, approved dossiers, and regulatory updates, visit Pharmatradz. Ensuring compliance guarantees access to affordable, high-quality biosimilar therapies for rare hematologic and complement-mediated conditions worldwide.