The Food and Drug Administration (FDA) has approved a new generic medication in the GLP-1 class, which may lead to more affordable options for weight loss treatments, enhancing accessibility.

Initially approved for managing type 2 diabetes, daily liraglutide injections are now available for use in both adults and children aged 10 and older. The newly approved generic, known as Victoza and manufactured by Hikma Pharmaceuticals USA Inc., follows last month’s approval of the generic GLP-1 drug exenatide, marketed as Byetta.

However, both of these generics are generally not as effective as the original weekly injections for managing diabetes and aiding weight loss, which include Ozempic and Wegovy from Novo Nordisk, as well as Mounjaro and Zepbound from Eli Lilly.

Dr. Fatima Cody Stanford, a weight loss expert at Massachusetts General Hospital in Boston, noted via email that having additional options “could indeed alter the prescribing landscape.”

The impact will largely depend on the pricing of these newly available medications, which has yet to be disclosed.

Dr. Cody Stanford emphasized that generics usually provide a more budget-friendly solution compared to their brand-name counterparts, which could help more patients gain access to necessary diabetes treatments.

High Costs Restrict Options

The monthly cost for both Ozempic and Mounjaro exceeds $1,000, which can be prohibitively expensive, even for individuals with private insurance, depending on the copay amount required.

Dr. Cody Stanford expressed hope that the introduction of lower-cost generics could motivate Novo Nordisk and Lilly to reduce their brand-name prices, and may also encourage more insurance providers to cover GLP-1 treatments for both diabetes management and weight loss.

Furthermore, offering generics for type 2 diabetes could alleviate demand for brand-name medications, possibly making them available at a lower cost for weight loss patients, although she noted that this speculation hinges on various market conditions.

While liraglutide has been available for a longer time than the newest GLP-1s, its effectiveness is lower, and it requires daily administration, which could limit patient enthusiasm, she pointed out.

Dr. Stanford added, “The current market preference leans toward weekly drugs with higher efficacy, which is another factor we need to consider.”

Understanding GLP-1s

GLP-1s are a category of medications that have proven to be the most effective in safely assisting weight loss compared to earlier treatments.

Since the FDA authorized Ozempic for diabetes treatment in 2017, the demand has been so high that suppliers have struggled to keep up.

Recently, the FDA announced that Lilly had successfully met the demand for its tirzepatide products, Mounjaro and Zepbound, which are now in stable supply. As a result, compounding pharmacies will soon need to cease offering less expensive alternatives to these medications.

In a news release on Monday, the FDA underscored its commitment to prioritizing the evaluation of generic drug applications for products currently in short supply, facilitating improved patient access.

Over 38 million Americans experience diabetes, a condition where their bodies struggle to regulate blood sugar levels. Only about 5% to 10% are diagnosed with type 1 diabetes, which stems from a long-term immune response against the pancreas. Type 2 diabetes generally progresses with time, influenced by diet and lifestyle alongside genetic predisposition.

GLP-1 medications are beneficial for those dealing with diabetes, although patients with the condition tend to lose less weight compared to those without it.