Preprint · Dec 16, 2025
Mapping the Biosimilar Landscape in Osteoporosis: Protocol for a Scoping Review of Regulatory, Clinical, and Implementation Pathways for Denosumab and Teriparatide Biosimilars
By Jaber A, El Chahni N, Crompton C et al.
This project is a scoping review examining biosimilars used in the treatment of osteoporosis, with a specific focus on denosumab and teriparatide. As biosimilars increasingly enter global markets, particularly in osteoporosis care, there is a need to clearly map how these products are defined, regulated, developed, and implemented across different health systems. The objective of this review is to synthesize and describe key concepts related to osteoporosis biosimilars, including regulatory definitions, approval pathways, principles of manufacturing and analytical comparability, and clinical development frameworks. The review will also map the global landscape of approved and emerging denosumab and teriparatide biosimilars, including regions of approval and manufacturers, and summarize implementation-related considerations such as pharmacovigilance, interchangeability policies, and clinical uptake. This scoping review will follow established methodological guidance and will include peer-reviewed literature as well as authoritative regulatory and policy documents from major agencies. Findings will be presented through descriptive narrative synthesis and structured summaries rather than quantitative analyses. The expected outcome is a clear and comprehensive overview of the current osteoporosis biosimilar landscape, providing contextual clarity for clinicians, researchers, and policymakers and identifying gaps to inform future research.