Novo Nordisk Shares Rebound Strongly Following FDA Warning Against Copycat Weight-Loss Drugs
Shares of pharmaceutical giant Novo Nordisk experienced a significant rebound in pre-market trading on Friday, climbing more than 5% after regulatory authorities issued stern warnings against illegal copycat versions of popular weight-loss medications. This recovery comes just one day after the stock plunged as much as 7.5% during Thursday's trading session following a controversial announcement from telehealth company Hims & Hers Health.
Hims & Hers Launches Lower-Priced Compounded Semaglutide Pill
The market volatility began when Hims & Hers Health revealed plans to offer a compounded version of the weight-loss drug semaglutide at a substantially reduced price point. According to Reuters reports, the telehealth firm announced it would sell this copycat version through a subscription program starting at just $49 per month. This represents a dramatic price difference compared to Novo Nordisk's branded version, Wegovy, which typically retails for approximately $149 per month.
The announcement triggered immediate concern among investors about potential market share erosion for Novo Nordisk, leading to Thursday's sharp decline in the company's stock value. However, the narrative shifted dramatically when regulatory authorities intervened with strong warnings about the legality and safety of such copycat products.
FDA Issues Stern Warning Against Illegal Copycat Drugs
Following Hims & Hers' announcement, FDA Commissioner Marty Makary took to social media platform X (formerly Twitter) to deliver a clear and forceful warning to pharmaceutical companies marketing unauthorized copycat medications. "FDA will take swift action against companies mass-marketing illegal copycat drugs, claiming they are similar to FDA-approved products," Commissioner Makary stated unequivocally.
The FDA Commissioner further emphasized that "The FDA cannot verify the quality, safety, or effectiveness of non-approved drugs," highlighting significant regulatory concerns about compounded versions of medications that haven't undergone the agency's rigorous approval process.
Novo Nordisk Responds with Legal Threats and Patient Safety Concerns
Within hours of the Hims & Hers announcement, Novo Nordisk issued a strong statement indicating its intention to pursue legal action against the telehealth company. The Danish pharmaceutical giant cited concerns about patient safety, protection of intellectual property rights, and the integrity of the United States drug approval framework as primary motivations for its planned legal response.
"The action by Hims & Hers is illegal mass compounding that poses a significant risk to patient safety," Novo Nordisk declared in its official statement. The company emphasized that it remains the sole producer of FDA-approved Wegovy capsules, distinguishing its product from unauthorized compounded versions.
Hims & Hers Defends Its Customer-First Approach
Facing sharp criticism from both regulatory authorities and pharmaceutical competitors, Hims & Hers Health issued a rebuttal on social media platform X. The company highlighted its track record of serving nearly 2.5 million customers and emphasized its commitment to expanding access to healthcare solutions.
"Our track record speaks for itself and is why we've been able to help nearly 2.5M customers access care personalized to their needs. We're focused on bringing more access, more positive outcomes, and more choice to customers everywhere," the company stated.
Hims & Hers further noted that this wasn't the first instance of large pharmaceutical companies challenging its customer-centric approach, describing such criticisms as "predictable as it is outdated and false."
FDA Provides Detailed Advisory on Compounded GLP-1 Drugs
In a separate press release issued on Wednesday, the FDA provided comprehensive guidance regarding unapproved versions of GLP-1 drugs, including semaglutide and tirzepatide. The regulatory agency emphasized that these compounded medications are sold without undergoing the FDA's standard review processes for safety, effectiveness, and quality before reaching the market.
The FDA specified that compounded GLP-1 drugs should only be utilized when medically necessary and exclusively in situations where a patient's requirements cannot be adequately addressed by FDA-approved alternatives. The agency also highlighted several significant risks associated with compounded medications, including:
- Improper storage conditions that may compromise drug efficacy
- Potential dosing errors that could endanger patient health
- Fraudulently sold products that may contain incorrect or harmful ingredients
According to FDA data current through July 31, 2025, the agency has received 605 adverse event reports specifically linked to compounded semaglutide and an additional 545 reports associated with compounded tirzepatide. The FDA cautioned that these figures likely represent underreported incidents, suggesting the actual number of adverse events may be substantially higher.
The regulatory scrutiny and subsequent market reactions highlight the ongoing tension between pharmaceutical innovation, patient access to affordable medications, and regulatory oversight in the rapidly expanding weight-loss drug market.
