The TGA is reviewing the first off-patent GLP-1 RAs – the class of diabetes and weight-loss drug shot to fame by Ozempic – after the US approved its first last week.
Off-patent biosimilars for glucagon-like peptide-1 receptor agonists should provide cost-effective alternatives to what’s currently on the market, says the CEO of the Australian Diabetes Society.
GLP-1 receptor agonists have become the diabetes and weight-loss drugs to beat over recent years, rising to household fame in the form of Ozempic.
Due to skyrocketing demand, a number of GLP-1 RAs have remained in short supply over recent years and are expected to stay as such into the distant future.
“It’s no secret that getting any GLP-1 for type 2 diabetes or obesity has been challenging in the last couple of years,” Associate Professor Sof Andrikopoulos told The Medical Republic.
“Supply has been an issue and also, for drugs not PBS reimbursed, then cost has also been a consideration for a lot of people.”
Last week, Teva Pharmaceutical announced the launch of the first ever generic GLP-1 RA in the US.
“By launching an authorised generic for Victoza (liraglutide injection 1.8mg), we are providing patients with type 2 diabetes another option for this important treatment,” said Teva’s US head of commercial generics Ernie Richardsen.
According to the TGA, two generic GLP-1 RAs are under review for approval in Australia, both of which are higher dose liraglutide biosimilars indicated for weight management.
CIPLA Aust’s generic liraglutide product, which is indicated as “an adjunct to a reduced-calorie diet and increased physical activity for weight management” and has not yet been named, was submitted for approval in October last year, the TGA told TMR.
Sun Pharma ANZ submitted an application for Liraglutide Sun, Liraglutide RBX, Solleen to the TGA in January. This product is indicated for weight management specifically in adults.
Professor Andrikopoulos told TMR he hoped the availability of generic GLP-1 RAs would help circumvent supply issues and provide a much-needed, cost-effective alternative to the current liraglutide product approved for weight loss in Australia – Novo Nordisk’s Saxenda.
“Having these generics come online will probably mean that even the private script cost would be much lower than what Saxenda is for obesity, which is around $380 a month,” he said.
Liraglutide is part of an older generation of GLP-1 RAs, preceding the recent class spearheaded by semaglutide (the active ingredient in Ozempic).
“[Liraglutide] is a once-daily and the weight loss is good but modest compared with what we have now,” said Professor Andrikopoulos.
“But I do think that if they are approved by the TGA, and the pricing is favourable, that they will be taken up as there will be a demand for them.”
Professor Andrikopoulos was hopeful the generics would be approved as liraglutide 3mg for obesity management was supported by clinical evidence as a safe and effective drug.
The SCALE study of Saxenda showed an average weight loss of over 8kg in obese adults when combined with exercise and diet over 56 weeks.
“They’re certainly effective,” said Professor Andrikopoulos.
It was unclear why the liraglutide generics under consideration by the TGA were focused on weight loss rather than diabetes, unlike the generic launched by Teva in the US, added Professor Andrikopoulos.
“I’m assuming that what’s happened is that these companies have seen a need in the market, as obesity is an issue, but we don’t have much [medication] for it and people are trying to use Ozempic where they can.”
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Currently no GLP-1 RAs are subsided through the PBS for weight loss.
Professor Andrikopoulos said he hoped the generic liraglutides could help fill the gap in the market for affordable obesity medication.
“Ozempic is indicated for type 2 diabetes,” he said.
“Given the recent shortages, it’s appropriate that that is the case, to prioritise people with type 2 diabetes.
“So if we have alternatives that are specific for obesity, that’s a good thing and that provides more choice for people with these chronic diseases.
“I’d encourage the regulator to approve these alternatives as quickly as possible because there’s clearly there’s a need: we need to manage obesity and its comorbidities.”
The TGA told TMR that the applications for the liraglutide biosimilars were submitted through the standard registration pathway which has a legislated timeframe of 255 working days.
