Hims & Hers drops plan for knockoff of Novo Nordisk’s new Wegovy weight loss pill

Telehealth company Hims & Hers abruptly abandoned its plan to offer a lower-cost alternative to Novo Nordisk’s weight-loss pill Wegovy on Saturday, just 48 hours after announcing the product. The reversal came amid mounting pressure from both Novo Nordisk, which had threatened legal action, and the Food and Drug Administration, which announced plans to restrict access to the active ingredients used in these popular weight-loss medications.

The San Francisco-based digital health platform had initially unveiled its compounded version of semaglutide—the active ingredient in Wegovy—on Thursday, pricing it at $49 for the first month and $99 monthly thereafter. This would have significantly undercut Novo Nordisk’s FDA-approved pill, which retails at $149 per month.

By Saturday afternoon, hours after announcing the cancellation on social media, Hims’ website was still promoting the semaglutide pill—a discrepancy that highlighted the hasty nature of the company’s retreat.

“Since launching the compounded semaglutide pill on our platform, we’ve had constructive conversations with stakeholders across the industry. As a result, we have decided to stop offering access to this treatment,” Hims said in a statement posted on X. “We remain committed to the millions of Americans who depend on us for access to safe, affordable, and personalized care.”

The company did not clarify whether it would continue offering compounded versions of injectable weight-loss medications that it has been selling, nor did it address whether the FDA’s regulatory action influenced its decision.

The controversy occurs amid exploding consumer interest in GLP-1 drugs, a class of medications that includes Wegovy, Ozempic, and Eli Lilly’s Zepbound. These drugs have transformed the obesity treatment market, creating a multibillion-dollar industry with demand frequently outstripping supply over the past two years.

Novo Nordisk plans to capitalize on this momentum with a celebrity-filled Super Bowl commercial on Sunday, highlighting its newly launched Wegovy pill—the first oral GLP-1 medication to receive FDA approval for weight management. Eli Lilly expects its own oral weight loss drug, orforglipron, to receive FDA approval later this spring, further intensifying competition in this lucrative market.

Importantly, the compounded medication Hims had planned to sell had not received FDA approval nor undergone clinical trials to demonstrate its efficacy or safety profile. The company had been operating in a regulatory gray area, as FDA regulations permit compounding pharmacies to create versions of branded drugs during official shortages.

The explosive popularity of GLP-1 drugs had previously led to supply constraints, allowing companies like Hims to enter the market as patients sought alternatives, often paying out-of-pocket due to limited insurance coverage for these expensive medications.

However, in early 2024, the FDA declared that GLP-1 drugs were no longer considered to be in shortage, a determination that should have curtailed compounding practices. Despite this, Hims and similar companies continued offering these medications by leveraging an exception that allows compounding when prescriptions are customized for individual patients.

The FDA’s announcement Friday of plans to restrict access to the active ingredients used in these compounded alternatives signals a tightening regulatory approach that could significantly impact telehealth companies that have recently expanded into the weight-loss medication market.

This episode highlights the complex regulatory and competitive landscape surrounding weight-loss medications, as pharmaceutical giants and digital health platforms vie for position in what analysts project could become a $100 billion market by the end of the decade. For patients seeking affordable access to these increasingly popular medications, the outcome represents another setback in navigating the high costs often associated with FDA-approved weight management therapies.