The makers of semaglutide, Novo Nordisk, have announced that shortages of the Ozempic brand of the GLP-1 receptor agonist for use in type 2 diabetes will continue for the rest of 2025.
A statement from the TGA said the pharmaceutical company had recently advised the regulator and the Ozempic Medicine Shortage Action Group (MSAG) that “supply will continue to be limited until 31 December 2025.”
A separate semaglutide product, Wegovy, is approved to assist with chronic weight management.
Based on consultations with health professionals and patient groups represented on the MSAG, the TGA has updated advice to health professionals is to:
- consider the ongoing shortage when prescribing Ozempic, inform patients that supply is expected to be limited in 2025 and discuss alternative treatments when patients are unable to access the medicine
- prescribe and supply both Ozempic and Wegovy according to their approved indications.
“Novo Nordisk advised that they are continuing to increase manufacturing capacity, but it would take time to build supply levels to meet global and local demand,” the statement noted.
In a separate announcement, the TGA has reported that Novo Nordisk will be discontinuing the Protaphane InnoLet human insulin (rys) 100 IU/mL injection multidose cartridge on 1 February 2025.
“We understand the news of this discontinuation may cause concern for people who use this product to manage their diabetes. We hope this early notice will give patients enough time to arrange ongoing treatment changes with the health care professional who prescribes their diabetes medicine,” the TGA said.
It advised that in the interim, pharmacists can use a Serious Scarcity Substitution Instrument- external site (SSSI) to dispense Protaphane Penfill human insulin (rys) 100 IU/mL injection multidose cartridge in the place of a Protaphane InnoLet cartridge, without a new prescription from the prescriber. The SSSI starts on 16 December 2024.
The TGA emphsised that a NovoPen device must be used to administer Protaphane Penfill cartridges, with a NovoPen 4 device recommended.