Compounding, Biosimilars, Generics, and the Semaglutide Supply

It leaves our heads spinning. Normal healthcare systems cannot keep up with the demand for a breakthrough in obesity treatment. The company, Novo Nordisk, which developed semaglutide for obesity treatment, has invested billions and now is reaping many billions of dollars in sales. But despite more than a decade of preparation, they can’t keep up. So compounding pharmacies are stepping in to make a buck, raising a host of questions about biosimilars and generics for semaglutide.

The stakes – like the price of Wegovy – are high in this confusing mess.

The Opening for Compounding Pharmacies

Because Novo Nordisk cannot meet the demand for semaglutide – either under the Ozempic brand for diabetes or the Wegovy brand for obesity – there is an opening for compounding pharmacies. These are pharmacies in the business of mixing up drug doses to meet the needs of individual patients. This typically leads them to make a special dose or a combination of drugs that is not available commercially in an FDA approved product.

So FDA says:

“When a drug is in shortage, compounders may be able to prepare a compounded version of that drug if they meet certain requirements in the Federal Food, Drug, and Cosmetic (FD&C) Act. As of May 2023, Ozempic and Wegovy are both listed on FDA’s Drug Shortages list.”

But Is It Safe and Effective?

This is the pivotal question and the short answer is that one cannot be sure. FDA is quite clear:

“Compounded drugs are not FDA-approved, and the agency does not verify the safety or effectiveness of compounded drugs.

“FDA has received adverse event reports after patients used compounded semaglutide.”

A legal generic version of a drug that is off patent has to go through an abbreviated approval process to prove that it is equivalent to the branded product. For more complex biological molecules, there is the option to gain FDA approval for a biosimilar equivalent product. This is because small variations in these complex molecules inevitably occur within and between lots of these medicines.

So to gain FDA approval for a biosimilar a manufacturer has to demonstrate that there are no “clinically meaningful” differences between the biosimilar and the original product for which it is a substitute. This can present additional challenges.

Either way, patients have some assurance of safety and effectiveness. For compounded semaglutide, we have none of this.

Putting Patients First?

All of this leaves patients in a bind. People who need this innovative medicine for obesity, diabetes, or both are facing an uncertain supply. Novo Nordisk has responded by limiting the supply of low doses of Wegovy needed to start on the medicine. But that’s not entirely satisfactory because some patients need to stay on a lower dose than others. So those patients are shut out. “We understand how frustrating this situation is,” says the company.

Perhaps they are doing the best they can – making billions of dollars and reinvesting billions to ramp up the supply. They are also busy suing compounding pharmacies and saying it may take years for them to meet the demand for semaglutide.

Or perhaps another organization can do better. We will find out soon. Tirzepatide, marketed by Lilly as Mounjaro for diabetes, is awaiting FDA approval for obesity.

Right now, despite strong demand for Mounjaro, all forms of it are fully available according to the FDA drug shortage website. We will watch closely to see if Lilly can steer clear of the mess that Novo Nordisk has made.

Click here, here, and here for more on compounded semaglutide.

Young Woman Holding a Syringe, painting by Henri-Pierre Danloux / WikiArt

Subscribe by email to follow the accumulating evidence and observations that shape our view of health, obesity, and policy.

October 30, 2023