Novo Nordisk announced it will pursue legal and regulatory action against Hims & Hers over the company's plan to market what Novo Nordisk calls an unapproved semaglutide pill product.

The Danish pharmaceutical company stated that Hims & Hers' announcement to mass-market a semaglutide pill constitutes "illegal mass compounding" and poses patient safety risks. Novo Nordisk described the product as an "unapproved, inauthentic, and untested knockoff."

Novo Nordisk said the FDA has previously warned Hims & Hers about deceptive advertising related to GLP-1 products. The company referenced recent American Diabetes Association standards that discourage compounded GLP-1 medications due to safety, quality and effectiveness concerns.

The company emphasized that only Novo Nordisk manufactures an FDA-approved oral semaglutide pill, marketed as Wegovy, which uses SNAC technology for oral absorption. Novo Nordisk stated this product is available in all doses and in full supply nationwide.

According to Novo Nordisk, compounded semaglutide products lack FDA approval and may contain impurities, unnecessary additives and untested doses. The company indicated it will take action to protect patients, its intellectual property and the drug approval framework.

The statement was issued from Novo Nordisk's headquarters in Bagsværd, Denmark and Plainsboro, New Jersey. Novo Nordisk employs approximately 68,800 people across 80 countries and markets products in around 170 countries.