HIMS to offer Liraglutide after shortage rule changes
HIMS leans into Liraglutide as a replacement for Semaglutide in the face of shortage rule changes. Is it good enough?
Earlier this year when the active peptide (Tirzepatide) in popular GLP1 Receptor Agonists Mounjaro and Zepbound was taken off the FDA shortage list, companies were forced to act quickly:
GLP1.Guide Staff
While the a large consortium of compounders effectively lobbied (and sued) the FDA into avoiding restrictions on compounding, other companies that provide GLP1s became wary and have now started trying to change their supply lines.
Who can manufacture GLP1s like Semaglutide and Tirzepatide?
Right now, there are essentially only two companies that can manufacture GLP1 Receptor Agonists – Eli Lilly and Novo Nordisk.
This isn't completely true of course – there are many other popular GLP1 Receptor Agonists that work in a similar way that can be substituted, but as far as the most popular formulations (Ozempic, Rybelsus, Wegovy, Mounjaro, Zepbound), these are produced by just the two above companies.
Check out our quick explainer
Compounders were able to start creating formulations of the drugs because of the FDA declared shortage on Tirzepatide and Semaglutide. This came into question with Tirzepatide being taken off the shortage list, but the FDA's note on reconsidering the list removal (and pledge to not pursue legal action against compounders) enabled compounders to continue for an indefinite while longer:
GLP1.Guide Staff
Clearly, this isn't sustainable – compounders cannot depend on being able to produce drugs that are not on the shortage list.
Things could get even worse – the FDA could remove Semaglutide from the shortage list. This means that compounders would have effectively no options on producing the most popular GLP1 agonist formulations.
What is HIMS doing about the potential restrictions?
There's one ray of hope – Liraglutide (also known as Victoza/Saxenda).
Liraglutide's patent protection recently elapsed, which means a large company like TEVA Pharmaceuticals can make a generic – and they did:
GLP1.Guide Staff
HIMS has announced plans to get ahead of the restrictions – by switching to Liraglutide instead:
The company is already starting the media churn/getting it's customers used to the new formulation:
Clearly, this is going to be the way forward for many firms that depend on compounding pharmacies. As Eli Lilly and Novo Nordisk regain their rights to be the sole producers of GLP1s, companies that compound will have to switch to versions of GLP1s that are not patent-encumbered.
The problem with this is that Liraglutide isn't as good as Semaglutide.
How do Liraglutide and Semaglutide compare?
A recently published clinical study shows that Liraglutide is about half as effective as Semaglutide:
Hamlet Gasoyan
The study is fairly large, and the results were stark:
Results: A total of 3389 patients (mean [SD] age, 50.4 [12.2] years; 1835 [54.7%] female) were identified. Of these, 1341 patients received semaglutide for T2D; 1444, liraglutide for T2D; 227, liraglutide for obesity; and 377, semaglutide for obesity. Mean (SD) percentage weight change at 1 year was -5.1% (7.8%) with semaglutide vs -2.2% (6.4%) with liraglutide (P < .001); -3.2% (6.8%) [..]
Will consumers continue to choose a formulation that's half as effective? Will manufacturers like TEVA and companies like HIMS attempt to fund research into making Liraglutide more effective? Only time will tell.
