Denosumab-Bbdz

Form: Injection for subcutaneous use

Strength: 60 mg, 120 mg

Reference Brands: Prolia(US & EU); Jubbonti - biosimilar to Prolia

Category: Biosimilars

Jubbonti, a biosimilar to Prolia (denosumab), is regulated in the EU and US with dossiers demonstrating biosimilarity, safety, efficacy, and manufacturing quality according to GMP standards. In the US, FDA approval involves extensive comparability, clinical validation, and safety data. In the EU, CE marking certifies conformity with MDR standards for biosimilars. These biosimilars undergo validation, stability testing, and audits, supported by comprehensive documentation including biosimilarity data, clinical trial results, safety profiles, and manufacturing practices. For licensing procedures, approved dossiers, and regulatory updates, visit Pharmatradz. Ensuring compliance guarantees access to affordable, high-quality denosumab biosimilars supporting osteoporosis and bone metastasis treatment worldwide.