Sandoz said the FDA has accepted for review two Abbreviated New Drug Applications for in-house developed generic versions of tirzepatide autoinjectors. The proposed products are described as a generic gastric inhibitory polypeptide receptor and glucagon-like peptide-1 receptor agonist and were filed through the FDA’s generic pathway.
The applications seek approval for all indications of the reference medicines Mounjaro and Zepbound. For Mounjaro, this includes use as an adjunct to diet and exercise to improve glycemic control in adults and pediatric patients aged 10 years and older with type 2 diabetes mellitus. For Zepbound, the proposed generic would be used alongside a reduced-calorie diet and increased physical activity to reduce excess body weight and maintain weight reduction in obese or overweight adults with at least one weight-related comorbidity, and to treat moderate to severe obstructive sleep apnea in adults with obesity for weight management.
According to the company, the generic tirzepatide autoinjector was developed internally at Sandoz, drawing on its experience in small-molecule, device and biosimilar development. Subject to FDA approval, Sandoz said its tirzepatide could be among the first generic tirzepatide products available to US patients once the market forms.
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