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Wednesday, 26 November 2025
Posted 26 November 2025 AM
The TGA has strengthened an existing safety alert for Amgen's osteoporosis treatment Prolia and equivalent denosumab biosimilar products, warning about the risk of multiple spinal fractures after discontinuation or delay in treatment.
The regulator has estimated that 70 cases reported on its Database of Adverse Event Notifications as of 9 October appeared to be associated with "rebound fractures" following stopping treatment with Prolia or delays in starting it.

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