A new GLP-1 generic is entering the U.S. market amid ongoing debates about cost, access and innovation within this increasingly popular drug class.
Here are five updates on this industry:
1. Weight loss results
Eli Lilly's obesity drug Zepbound — which saw a 300% increase in prescription fills throughout 2024 — led to higher weight loss than its competitor, Novo Nordisk's Wegovy. In a 72-week trial with 751 participants, those taking Zepbound lost an average of 20.2% of their body weight compared to 13.7% for those taking Wegovy.
A 2023 study noted similar results. Eli Lilly's Type 2 diabetes drug Mounjaro, which shares the same active ingredient as Zepbound, outperformed Novo Nordisk's diabetes drug Ozempic (which shares Wegovy's active ingredient) in weight reduction.
That research analyzed 41,223 EHRs of overweight or obese patients using Mounjaro or Ozempic and found Eli Lilly's medication was more likely to cause 5%, 10% and 15% weight loss than Ozempic.
2. FDA decisions
On Dec. 19, the FDA reaffirmed its decision about the tirzepatide (Mounjaro and Zepbound) shortages. In October, the agency declared the supply issue resolved, prompting a lawsuit from the Outsourcing Facilities Association and a compounding pharmacy. They argued that the two-year shortage was ongoing and that the FDA's decision would restrict access.
Federal law permits compounding pharmacies to manufacture medications on the FDA's drug shortage list. However, with the FDA’s recent decision, these pharmacies have 60 to 90 days to either cease manufacturing tirzepatide or find alternative legal pathways.
On Dec. 20, the agency approved Zepbound for a second indication: obstructive sleep apnea. It is now the only approved drug for this condition.
Additionally, on Dec. 23, the agency approved Hikma Pharmaceuticals' generic version of Novo Nordisk’s liraglutide injectable, Victoza. Teva Pharmaceuticals also offers a generic form of Victoza, a GLP-1 drug first approved for Type 2 diabetes in 2010.
3. Cost issues
GLP-1 list prices are about $1,000 for a four-week supply, a contentious issue among patients, legislators and healthcare executives. Generics could introduce price competition, and CMS price negotiations might further reduce costs.
HHS recently reported net price drops for two Novo Nordisk diabetes drugs, Rybelsus and Ozempic. Over a few years, Ozempic's net price decreased from $531 to $290 and Rybelsus' net price fell from $376 to $296 for individuals covered by Medicare or commercial insurance.
Still, many insurers have reduced or eliminated GLP-1 coverage, citing financial challenges.
4. Safety concerns
Cost barriers and side effects have led some GLP-1 patients to microdose by breaking open their GLP-1 injection pens to divide doses. It's unclear if this practice is safe, though.
Additionally, more research has identified a rare risk associated with Ozempic and Wegovy: non-arteritic anterior ischemic optic neuropathy. This eye condition results from reduced blood flow to the optic nerve, potentially causing painless, sudden vision loss in one eye.
5. Spillover effects
The GLP-1 drug class has influenced various phenomena, from airlines predicting fuel savings to speculation about an "Ozempic baby boom." Researchers at Boston Children's Hospital and Optum Life Sciences recently suggested these medications may contribute to a decline in U.S. obesity rates.
Between 2013 and 2022, national obesity rates and mean BMI rose annually, but both slightly declined in 2023. The researchers cited demographic and behavior shifts from the COVID-19 pandemic as additional factors.
Increased GLP-1 prescriptions have also coincided with higher first-time diagnoses for Type 2 diabetes, obesity and sleep apnea. Among 700,000 patients who began using a GLP-1 medication from January 2018 to October 2024, new diagnoses for these conditions were more likely within 15 days of starting treatment.