Drugmaker wants an end to Ozempic copies

Presented by Alliance for Aging Research — Plus: FDA recalls thousands of antidepressant bottles due to cancer-causing chemical {beacon} Health Care Health Care The Big Story Novo Nordisk wants its drug out of the compounding space The maker of Ozempic and Wegovy wants the FDA to block compounding pharmacies from making their own, markedly...

Oct 24, 2024 - 04:00

Drugmaker wants an end to Ozempic copies

Presented by Alliance for Aging Research — Plus: FDA recalls thousands of antidepressant bottles due to cancer-causing chemical

{beacon}

Health Care

The Big Story

Novo Nordisk wants its drug out of the compounding space

The maker of Ozempic and Wegovy wants the FDA to block compounding pharmacies from making their own, markedly cheaper versions of the drugs.

Novo Nordisk says the medications it produces are too complex for compounding pharmacies to make safely.

Novo asked the Food and Drug Administration (FDA) to add semaglutide to a list of “complex medications” that compounders are not allowed to make, regardless of shortages, pointing to potential safety risks.

The drugmaker argued in a statement that the risks of copied versions on patient health "far outweigh any benefits."

Remember: Compounding pharmacies are legally allowed to make their own versions of drugs that are in shortage.

Semaglutide, the active ingredient in Ozempic and Wegovy, has been in shortage for over two years now. In that time, compounding pharmacies and the telehealth companies that own or contract with them have been able to circumvent Novo Nordisk’s exclusive hold on the drug.
Ozempic and Wegovy carry a cost of about $1,000 a month before any discounts, and many insurance plans don’t cover semaglutide for weight loss. Compounded versions sell for a fraction of the price, making them an affordable alternative.

But: Novo says those versions aren’t safe because the compounded drugs are not FDA-approved. The request to the FDA is an escalation of the company’s attempts to stop what it says is unsafe compounding, after previously filing dozens of lawsuits against compounders and telehealth companies.

Another fight: Novo’s request follows an ongoing dispute between Eli Lilly (the maker of Mounjaro and Zepbound) and compounding pharmacies.

Earlier this month, the FDA removed tirzepatide, the active ingredient in Mounjaro and Zepbound, from its shortage list. Lilly then sent out a spate of cease-and-desists to pharmacies and medical spas selling compounded tirzepatide.
Compounders in turn argued the shortage wasn’t over and filed a lawsuit, leading FDA to say it is currently reconsidering the move.

Welcome to The Hill’s Health Care newsletter, we’re Nathaniel Weixel, Joseph Choi and Alejandra O'connell-Domenech — every week we follow the latest moves on how Washington impacts your health.

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