In response to the impact of U.S. generic drugs, Novo Nordisk calls on the FDA to ban the import of key raw materials for generic drugs

Novo Nordisk calls for the U.S. to ban the import of "generic drug raw materials."

On Wednesday, August 6, Danish pharmaceutical giant Novo Nordisk is urging U.S. regulators to ban the import of a key active ingredient used in the production of "knockoff" generic versions of its weight loss and diabetes medications.

In this regard, Novo Nordisk's Chief Financial Officer Munk Knudsen explained that these so-called "custom compounded drugs" pose significant risks to patient safety and also impact the company's business. Novo Nordisk estimates that about 1 million Americans are using generic versions of its core ingredient semaglutide, most of which should have been banned starting in May of this year.

Under the dual pressure of competitors and generic drug manufacturers, Novo Nordisk lowered its full-year sales and profit expectations last week and announced a CEO transition plan, with the new CEO starting this week.

On Wednesday, Novo Nordisk's U.S. stock fell about 2% in early trading.

Novo Nordisk is consulting with the FDA to push for clearer legislation

Knudsen revealed that Novo Nordisk is in communication with the U.S. Food and Drug Administration (FDA) and has proposed a series of measures, including clarifying the legal definition of "personalized compounded" drugs, establishing quality standards for the active pharmaceutical ingredients (APIs) used in such drugs, and hoping the FDA will clearly announce that importing active ingredients for compounded drugs is illegal.

Knudsen cited an example, stating that they hope the FDA will at least make a clear statement prohibiting the import of APIs for compounding into the U.S.

This week, Novo Nordisk filed lawsuits against 14 more knockoff drug manufacturers, bringing the total number of lawsuits to about 130, in addition to sending over 1,000 "cease and desist" letters. CFO Knudsen stated that they believe these compounding drug manufacturers are currently operating in a significant gray area.

Core product growth slows, stock price suffers heavy losses

Novo Nordisk's star product, including the diabetes drug Ozempic, has seen a significant slowdown in sales growth. In the first half of the year, it grew only 8% year-on-year, far below last year's level.

In the face of pressure, the company announced it would cut costs, strengthen market execution, and focus on future growth strategies. Last week, Novo Nordisk lowered its full-year sales and profit expectations, directly leading to a market value evaporation of over 60 billion euros.

Due to performance pressures, Novo Nordisk decided to change leadership to seek a turnaround. Former CEO Lars Fruergaard Jørgensen was replaced in May, and new CEO Mike Doustdar officially took office this week.

In his farewell speech, Jørgensen stated that over 1 billion people worldwide suffer from obesity, with more than 1 million in the U.S. alone, but very few receive treatment. He believes that under Doustdar's leadership, Novo Nordisk will maximize future growth opportunities supported by a strong product portfolio and R&D pipeline Novo Nordisk warned last week that its full-year sales growth expectation is 8% to 14%, significantly lower than the previous estimate of 13% to 21%. The company also lowered its profit growth expectation for 2025 from the previously guided 16% to 24% down to 10% to 16%.

In terms of market share, Novo Nordisk holds a 51% market share for GLP-1 drugs in the United States, and a market share as high as 71% in international markets. This year, Wegovy has been launched in 15 new countries