By Patrick Wingrove
(Reuters) – Novo Nordisk on Tuesday asked the U.S. Food and Drug Administration to ban compounding pharmacies from making copycat versions of its popular weight-loss and diabetes drugs, which it said were too complex for those manufacturers to produce safely.
U.S. regulations allow compounders to copy brand-name medicines that are in short supply by combining, mixing or altering drug ingredients to meet demand. Novo’s Wegovy and diabetes drug Ozempic, both known chemically as semaglutide, have been in shortage in the U.S. for much of this year.
In its submission, the Danish drugmaker asked the FDA to consider placing semaglutide on a list of drugs that, even though they are in shortage, are too complex to be copied.
Novo said compounded versions of Wegovy are being sold in incorrect dosage strengths, have been found to contain unknown impurities, and have been linked to nearly 400 serious adverse events since 2018.
The FDA told Reuters it was reviewing Novo’s petition and would respond directly to the drugmaker.
Novo said in a statement it wanted to ensure patients only received FDA-approved, safe, and effective semaglutide products.
The Alliance for Pharmacy Compounding, which represents compounding pharmacists and technicians, said in its statement that Novo was “confusing the fact that the semaglutide molecule is demonstrably difficult to manufacture … with the relative simplicity of compounding with it.”
Novo Nordisk’s submission is its latest attempt to stop different businesses from selling unapproved and often-cheaper versions of Wegovy, which lists for more than $1,000 for a month’s supply.
The Danish drugmaker and rival Eli Lilly have together sued dozens of medical spas, weight-loss clinics, compounding pharmacies and online vendors for selling products claiming to contain the active ingredients in their obesity drugs.
The FDA this month said it had agreed to reconsider a decision to bar compounders from selling their own versions of Lilly’s weight loss and diabetes medicines after they were taken off the agency’s shortage list.
(Reporting by Patrick Wingrove; Editing by David Gregorio)
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