Denosumab-bbdz: A Review of the Interchangeable Biosimilar for the Treatment of Osteoporosis.

Objective: The objective of this article is to review the pharmacologic and clinical profile of denosumab-bbdz (GP2411, SDZ-deno), the first interchangeable RANK ligand inhibitor biosimilar for the treatment of osteoporosis and to increase bone mass.

Data sources: PubMed was searched for all indexed literature published prior to January 1, 2025, using the keywords GP2411, SDZ-deno, and denosumab-bbdz. Information was also extracted from the denosumab-bbdz package insert and a gray literature search.

Study selection and data extraction: Phase I and III studies of the pharmacokinetic, pharmacodynamic, and clinical profile of denosumab-bbdz were reviewed.

Data synthesis: Denosumab-bbdz received Food and Drug Administration approval based on the phase I/III ROSALIA trial which demonstrated similar pharmacokinetics, pharmacodynamics, efficacy via bone turnover rates, immunogenicity, and safety between denosumab-bbdz and reference product denosumab. Denosumab-bbdz carries a boxed warning and Risk Evaluation and Mitigation Strategy for severe hypocalcemia in patients with advanced chronic kidney disease.Relevance to Patient Care and Clinical Practice in Comparison to Existing Drugs:Denosumab-bbdz has interchangeable status which allows substitutions without prescriber approval and reduces costs. Denosumab-bbdz assumes the same place in therapy as other denosumab products. In addition to other indications, it is a first-line option for postmenopausal osteoporosis with high or very high fracture risk after achieving equivalence in pharmacologic properties, safety, and markers for bone formation.

Conclusions: Denosumab-bbdz is the first interchangeable biosimilar for denosumab. This approval has the potential to reduce costs to patients and the healthcare system and sets an encouraging future for the potential of biosimilars.