Denosumab(Others Approved)

Form: Subcutaneous injection

Strength: 60 mg, 120 mg

Reference Brands: Xgeva(US & EU) Ospomyv, Xbryk, Merilog, Stoboclo, Zadenvi, Enwylma, Denbrayce, Izamby - biosimilar to Xgeva

Category: Biosimilars

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