Could FDA’s approval of a generic lead to lower cost Ozempic?

In a move that could eventually make weight loss drugs cheaper and easier to access, the Food and Drug Administration Monday approved a second generic in the category of medications known as GLP-1s.

The drugs were first approved to treat type 2 diabetes – and that’s what the FDA said daily injections of liraglutide could be used for in adults and children 10 and up. The new drug, sold under the name Victoza and made by Hikma Pharmaceuticals USA Inc., follows the approval of the generic GLP-1 exanatide last month, sold under the name Byetta.

Neither drug is considered as effective as the brand-name weekly injections sold for diabetes and weight loss as Ozempic and Wegovy by Novo Nordisk and Mounjaro and Zepbound by Eli Lilly.

Still, having more options “could indeed impact the prescribing landscape,” Dr. Fatima Cody Stanford, a weight loss specialist at Massachusetts General Hospital in Boston, said via email.

But it will depend on the cost of these new drugs, which have not yet been 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,” Cody Stanford said.

High costs limits options

The list price for Ozempic and Mounjaro each run more than $1,000 a month, which can be difficult to afford, even for people with private insurance, depending on the required copay.

Cody Stanford said she hopes lower-priced generics will trigger Novo Nordisk and Lilly to lower the price of their brand-name drugs, and could encourage more insurers to cover GLP-1 medications for both diabetes and weight loss.

Providing generics for type 2 diabetes patients might also help reduce demand on the brand-name drugs, making them more available and potentially less expensive for people who need them for weight loss, she said, quickly adding “though this is speculative and would depend on several market factors.”

Liraglutide has been available for years longer than the most popular GLP-1s, but it is less effective and has to be given daily, which might dampen patient interest, she said.

“The market demand is currently for weekly agents with a higher level of efficacy,” she said. “So, we must take this into account also.”

What are GLP-1s

GLP-1s are a class of drugs that have proven more effective than any previous medications at helping people lose weight safely.

They are so effective, suppliers haven’t been able to meet demand almost since the FDA approved Ozempic for diabetes in 2017.

Last week, the FDA said Lilly had sufficiently met demand for its tirzepatide products, Mounjaro and Zepbound, so they are no longer in short supply ‒ meaning compounding pharmacies will soon have to stop selling cheaper versions of the drugs.

In a Monday news release, the FDA said it “prioritizes assessment of generic drug applications for drugs in shortage to help improve patient access to these medications.”

More than 38 million Americans have diabetes, meaning their bodies cannot maintain normal levels of blood sugar. Only 5% to 10% have type 1 diabetes, which is caused by a chronic immune attack on the pancreas. Type 2 diabetes typically develops over time, with diet and lifestyle compounding genetic vulnerability.

GLP-1s are helpful for people with diabetes, though they typically lose less weight than people without the disease.

Karen Weintraub can be reached at kweintraub@.com.

(This story has been updated to add a video.)