FDA Approves Generic Liraglutide for Type 2 Diabetes

The FDA has approved the first generic version of liraglutide injection, originally sold as Victoza, for treating type 2 diabetes.

This approval, granted to Hikma Pharmaceuticals USA Inc. on December 23, 2024, permits use in adults and pediatric patients aged 10 years and older.

The generic version is an 18 mg/3 mL injection, designed to complement diet and exercise in managing blood sugar levels.

Liraglutide is a glucagon-like peptide-1 (GLP-1) receptor agonist, which helps lower blood sugar effectively.

This comes on the heels of another FDA approval last month, introducing a generic referencing Byetta (exenatide), the first generic in the GLP-1 class of medications.

The introduction of generic liraglutide addresses an ongoing shortage of GLP-1 medications, including the branded Victoza.

Liraglutide was initially approved by the FDA in 2010 for adults and later expanded to include children aged 10 years and older in 2019.

Sales of branded liraglutide (6 mg/mL) in the U.S. totaled $1.3 billion in the 12 months ending October 2024.

The FDA approval aims to provide cost-effective treatment options, improving access for diabetes patients.

The branded version of liraglutide, marketed for both diabetes and obesity, costs between $500 and $815 per package before discounts.

While generic liraglutide offers promise, experts emphasize the need for multiple generics to drive significant price reductions.

Newer weekly GLP-1 drugs, like semaglutide, remain unavailable as generics and are significantly more expensive.

This approval aligns with the FDA's broader efforts to improve patient access to vital medications amid shortages.

Key Take-Home Points

• The FDA has approved generic liraglutide and Byetta (exenatide), increasing options for type 2 diabetes treatment.
• Generic liraglutide is approved for adults and children aged 10 years and older.
• These generics address ongoing shortages and provide cost-effective alternatives to branded drugs.
• Liraglutide is a GLP-1 receptor agonist, helping manage blood sugar effectively.
• The approval is part of efforts to enhance affordability and accessibility for diabetes care.
• More generics entering the market are needed to achieve substantial price reductions.
• Newer weekly GLP-1 drugs, while more effective, remain unavailable as generics and are costly.
• This progress is a step toward addressing medication shortages and expanding treatment options.

Learn More from the FDA Website