Hims & Hers Health Inc said an analysis of more than 10,000 patients taking a copycat version of Novo Nordisk A/S’s Ozempic and Wegovy showed the shot was a safe and effective way to shed pounds.
Patients started off weighing between 200 and 210 pounds, and lost roughly 9.3 pounds on average in the first month, according to the report from the San Francisco-based company. Side effects such as nausea and vomiting were mostly tolerable, it found.
Hims is pushing back on the idea that compounded injections aren’t as safe or beneficial as the brand-name drugs sold by Novo and Eli Lilly & Co., even as those companies turn to the courts and the public with allegations of potential harm. The copies, which can be sold when brand-name medications are in shortage, aren’t evaluated for their safety or effectiveness, according to the US Food and Drug Administration.
At stake is one of the largest and fastest-growing areas for the pharmaceutical industry, with analysts estimating that the market for the drugs used to treat obesity and diabetes may reach $130 billion by 2030.
The results offer “a powerful proof point of the efficacy and safety of compounded medications,” Chief Medical Officer Pat Carroll said in an interview.
The company acknowledged the findings don’t provide a head-to-head comparison and the conclusions haven’t been published in a scientific journal, though it said a peer-reviewed study is in the works. The initial results appear consistent with the few studies available on the one-month results for patients prescribed the brand-name shots for weight loss, it said in the report.
“As far as we can tell they’re just as safe, do not have more side effects and seem to have weight loss with them,” Craig Primack, senior vice president of weight loss, said in an interview.
Hundreds of thousands of Americans have been taking compounded weight-loss drugs, which are typically cheaper and easier to get than the brand-name medications from Novo and Lilly that have been in short supply. The drawback is they haven’t gone through the same rigorous testing required before approval by US regulators. Hims sells both the brand name medicines and compounded versions of Novo’s shots.
Novo and Lilly have been raising alarms for months about the dangers of taking copycat versions, including allegations that they may contain bacteria or impurities. Issues with compounded weight-loss drugs have also been investigated by state boards of pharmacy across the country.
Compounding pharmacies, for their part, say they make high-quality drugs using real ingredients from legitimate suppliers. They also argue that they play an important role in making sure medicines are available when there are shortages of the FDA-approved drugs.
Telehealth companies like Hims and Ro have tried to quell concerns by providing customers with documentation that their medications meet regulatory standards. Still, the compounding lobbying organization advises the pharmacies not to market their drugs as safe and effective.
Improving Access
The lower prices of the copycat drugs also allow more people to get them, the companies claim. The brand-name weight-loss medications can be priced at more than $1,000 a month, before any insurance coverage, while compounded drug from Hims costs $199 a month.
About 29% of customers in a separate survey from Hims said they tried to get weight-loss drugs prior to signing up with the company. While two-thirds said they had a prescription, half of those patients couldn’t fill it because they didn’t have insurance coverage, it cost too much or it wasn’t available, according to the report.
Prices and side effects have made it difficult for some people to remain on the drugs. About 30% of those prescribed Novo’s Saxenda or Wegovy for weight loss stopped in the first month, according to a study of 170,000 people published in May.
Hims, however, said just 13% of customers canceled their treatment subscriptions in the first month, likely because its drugs are cheaper and offered outside normal insurance channels. It also provides customized dosing, which it said can help with side effects, and around-the-clock support from licensed health practitioners.
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