Kerry Fulford, a pharmaceutical analyst at Berenberg, told the BBC that this was the “first move Novo Nordisk is making to clamp down on compounding”.
Compounding is a legal process, external in which US drug makers are allowed to sell medication that is not approved by authorities but offers alternatives for patients with specific needs.
Hims & Hers weight-loss drugs are compounded, whereas Novo Nordisk’s are not.
The US Food and Drug Administration (FDA) said on Friday, external it was taking steps to restrict the compounding of weight-loss drugs to “safeguard consumers from drugs for which the FDA cannot verify quality, safety, or efficacy”.
Novo Nordisk referenced the FDA’s concerns in its lawsuit announcement on Monday, saying Hims & Hers’ compounded drugs “may contain dangerous impurities or incorrect amounts of active ingredients, which can result in life-threatening immune responses”.
“This is Novo’s way of fighting back,” said Fulford.
The Danish firm has had a rocky few months. It announced thousands of job cuts in September and last week warned investors about a slump in profits due to expiring patents.
Novo Nordisk has also come under fire from the FDA.
The agency sent Novo Nordisk a letter on Thursday, external saying a TV advert for its Wegovy pill “misleadingly impl[ies] benefits beyond physical weight loss such as emotional relief, reduced psychological burden, hope, or direction for patients’ lives”.
Novo Nordisk said in response it “takes all regulatory feedback seriously and are in the process of responding to the FDA to address their concerns regarding the advertisement’s presentation”.