The Food and Drug Administration approved a second generic in the GLP-1 pharmaceutical category on Monday, potentially making weight reduction therapies less expensive and more accessible in the future.
The medications were first licensed to treat type 2 diabetes, and the FDA stated that daily injections of liraglutide could be used in adults and children aged 10 and older.
The new medicine, Victoza, is manufactured by Hikma Pharmaceuticals USA Inc. and follows last month’s approval of the generic GLP-1 exanatide, Byetta.
Neither medicine is thought to be as effective as brand-name weekly injections for diabetes and weight loss, such as Novo Nordisk’s Ozempic and Wegovy, and Eli Lilly’s Mounjaro and Zepbound.
However, having more options “could indeed impact the prescribing landscape,” said Dr. Fatima Cody Stanford, a weight reduction expert at Massachusetts General Hospital in Boston, via email.
However, it will be determined by the cost of these new drugs, which have yet to be made public.
“Generics typically offer a more affordable option compared to brand-name drugs, which could increase accessibility for patients requiring treatment for type 2 diabetes,” Dr. Cody Stanford said.
High costs limits options
Ozempic and Mounjaro have list prices that exceed $1,000 per month, making them difficult to purchase, even for persons with private insurance, depending on the required copay.
Cody Stanford expressed hope that lower-cost generics may prompt Novo Nordisk and Lilly to cut the prices of their brand-name treatments, potentially encouraging more insurance to cover GLP-1 therapies for both diabetes and weight loss.
Providing generics for type 2 diabetes patients may also help lower demand for brand-name medications, making them more available and potentially less expensive for people who require them for weight loss, she said, swiftly adding, “though this is speculative and would depend on several market factors.”
Liraglutide has been available for longer than the most popular GLP-1s, but it is less effective and must be administered daily, which may reduce patient interest, she said.
“The market demand is currently for weekly agents with a higher level of efficacy,” she informed me. “So, we must take this into account also.”
What are GLP-1s
GLP-1s are a class of pharmaceuticals that have proven to be more effective than earlier medications in terms of helping patients lose weight safely.
They are so successful that suppliers have been unable to meet demand for nearly two years, since the FDA approved Ozempic for diabetes.
The FDA has announced that Lilly’s tirzepatide medications, Mounjaro and Zepbound, are no longer in short supply. This means that compounding pharmacies will no longer be able to sell cheaper versions of these pharmaceuticals.
In a Monday press statement, the FDA stated that it “prioritizes the assessment of generic drug applications for drugs in shortage to help improve patient access to these medications.”
More than 38 million Americans are diabetic, which means their bodies are unable to maintain appropriate blood sugar levels. Only 5% to 10% of people have type 1 diabetes, which is caused by a long-term immunological attack on the pancreas. Type 2 diabetes usually develops over time, with food and lifestyle factors exacerbating genetic risk.
GLP-1s benefit diabetics, however they often lose less weight than non-diabetics.