Tocilizumab-Bavi

Form: Intravenous infusion

Strength: 80 mg/4ml

Reference Brands: Actemra; Tofidence - biosimilar to Actemra (tocilizumab).

Category: Biosimilars

Ofidence, a biosimilar to Actemra (tocilizumab), is regulated in the EU and US, supported by dossiers demonstrating biosimilarity, safety, efficacy, and manufacturing quality according to GMP standards. In the US, FDA approval involves extensive comparability data, clinical validation, and safety assessments. In the EU, CE marking confirms conformity with MDR standards. These biosimilars undergo validation, stability testing, and audits, with comprehensive documentation including biosimilarity, clinical 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 inflammatory and autoimmune diseases globally.