While first-line bisphosphonates are generically available, and biosimilars/synthetic peptide generics to the first anabolic therapy Forteo (teriparatide) started to be introduced in 2019, the branded osteoporosis market has continued to grow, driven by Amgen’s market-leading Prolia (denosumab) and to a lesser degree by novel anabolics with efficacy and convenience advantages over Forteo. In March 2024, the US Food and Drug Administration (FDA) approved Sandoz’s Jubbonti, the first interchangeable biosimilar to Prolia. However, launch details are uncertain due to ongoing litigation between Amgen and Sandoz, which could delay the impact on market growth from biosimilar competition. 

The American Society for Bone and Mineral Research (ASBMR) announced in November 2023 that the SABRE (Strategy to Advance BMD as a Regulatory Endpoint) project team has submitted its full qualification plan to the FDA to use treatment-related change in bone mineral density (BMD) as a surrogate endpoint for fractures in future trials of new anti-osteoporosis drugs. In March 2024, the FDA communicated that a ruling for this plan would be provided within 10 months. Historically, the FDA and European Medicines Agency have required registrational studies to have fracture as the primary endpoint. If accepted, the new BMD endpoint could mitigate development risk and expedite the drug development process. 

This Datamonitor Healthcare report contains a Disease Analysis module.