San Francisco-based telehealth provider Hims & Hers revealed plans on Thursday to launch an oral, compounded form of semaglutide, offering a lower-priced alternative to Novo Nordisk's branded weight-loss medication Wegovy. This introduction follows shortly after the pharmaceutical giant unveiled its novel pill formulation of the blockbuster GLP-1 drug, which had long been available only as an injection.
Wegovy has transformed how weight loss is treated in the United States, driving substantial demand for GLP-1 medications. Hims & Hers has proactively pursued this market by supplying compounded weight-loss drug versions, previously available as injections. Their new pill continues this strategy by delivering the same active ingredient as Wegovy, yet at a significantly reduced introductory cost of $49 for the first month, followed by $99 monthly—a price notably below Novo Nordisk's $149 monthly charge.
However, the launch has drawn immediate pushback from Novo Nordisk, which has condemned Hims & Hers's product as "an unapproved, inauthentic, and untested knockoff" of semaglutide, emphasizing legal and regulatory steps to safeguard patients, intellectual property rights, and the integrity of the U.S. drug approval system.
While the Food and Drug Administration issued a warning letter to Hims in September against misleading marketing claims equating its compounded products to FDA-approved GLP-1 drugs, Hims retains market presence on the grounds that its pills are compounded medications. Such drugs, customized for individual patients, do not undergo the stringent federal regulation applied to mass-produced pharmaceuticals.
The FDA's guidelines allow compounding of brand-name drugs when shortages exist, a condition that previously justified Hims's offerings. With the recent cessation of GLP-1 drug shortage declarations beginning in 2024, compounding is expected to diminish, except in circumstances involving patient-specific prescriptions and dosage customization.
Hims asserts that its approach enables personalized dosing and formulation preferences, enhancing patient support beyond the capabilities of standard treatments. Dr. Craig Primack, who leads the company's weight-loss products, highlighted in the announcement the platform's advancement toward deeper personalization, catering to patients seeking customized semaglutide experiences.
The pharmaceutical market responded swiftly, with Novo Nordisk’s shares dropping more than 8% during midday trade on Thursday.