The First Generic GLP-1 Receptor Agonist

The release of the first-ever generic GLP-1 receptor agonist marks a significant milestone in expanding treatment options for individuals with Type 2 Diabetes.

Victoza for Diabetes

With over 38 million individuals diagnosed with diabetes in the United States, there is a substantial market for medications to manage this condition. Victoza, manufactured by Novo Nordisk, was the second glucagon-like peptide-1 (GLP-1) receptor agonist approved for lowering blood sugar and A1C in adults with Type 2 Diabetes. Its use was later expanded to include individuals aged 10 years and older. In 2017, Victoza received an additional indication for reducing the risk of heart-related events in patients with Type 2 Diabetes and heart disease.

GLP-1 Receptor Agonists

GLP-1 receptor agonists are a class of medications primarily used to treat Type 2 Diabetes. The most well-known GLP-1 agonist is Ozempic (semaglutide), but other notable medications in this class include Victoza (liraglutide) and Trulicity (dulaglutide).

These medications have FDA-approved indications for either Type 2 Diabetes treatment or obesity management. They work by mimicking the GLP-1 hormone, which increases insulin release after meals when blood sugar is high, thereby helping to lower blood sugar and A1C levels. Additionally, GLP-1 agonists reduce appetite and slow stomach emptying, contributing to weight loss.

Increased Accessibility with Generic Options

Despite their effectiveness, the high cost of GLP-1 agonists can make them inaccessible for many patients. In 2024, Teva Pharmaceuticals, the world's largest manufacturer of generic medications, announced the launch of the first generic GLP-1 agonist, an authorized generic for Victoza. This development is expected to improve access to these vital medications for many individuals with Type 2 Diabetes.

Approving a Generic Medication

Generic medications offer patients and healthcare systems a cost-effective alternative to brand-name drugs without compromising efficacy or safety. These drugs are scientifically equivalent to their brand-name counterparts in terms of dosage, strength, route of administration, quality, performance, and intended use.

In 2017, Teva Pharmaceuticals submitted an application to the FDA seeking approval for a generic version of Novo Nordisk’s injectable GLP-1 receptor agonist, Victoza. Following negotiations, Teva obtained permission to launch this generic GLP-1 receptor agonist under specific conditions—namely, when the liraglutide patents were no longer active or if another generic version entered the market. On June 24, 2024, Teva announced the release of their authorized generic of Victoza in the United States.

What is an Authorized Generic?

Most generic medications, known as "ANDA generics," require an Abbreviated New Drug Application for approval. These generics are typically manufactured by a different company than the original brand-name product and may have different inactive ingredients and appearances (such as color, shape, and size).

A notable exception to the ANDA process is the authorized generic. Authorized generics are identical to the original brand-name product and are usually manufactured by the same company. The only differences are the label and, often, the price. Instead of submitting an ANDA, the FDA requires the original manufacturer to notify them if they decide to market an authorized generic.

Teva’s new generic Victoza is an authorized generic, making it the first generic version of a GLP-1 receptor agonist on the market.

Accessibility and Cost Implications

A primary advantage of generic medications is their potential to lower costs for patients. Historically, the introduction of authorized generics has often led to reduced drug prices and improved insurance coverage.

Victoza, a widely prescribed GLP-1 receptor agonist, generated over $1.5 billion in annual sales as of April 2024. As the first generic in this class, it represents a significant step toward potentially increasing accessibility and affordability for patients. However, while we closely monitor the availability and pricing of generic Victoza, it is currently anticipated that the price reduction may be less substantial than typical generic launches.

Several factors could influence the pricing of this new generic, including its status as an authorized generic, the overall market dynamics for GLP-1 agonists, and potential pricing strategies employed by the manufacturer.