In recent months, a wave of off-brand weight loss drugs mimicking the blockbuster medications Wegovy and Zepbound has inundated the market. These cheaper alternatives, which are heavily advertised across social media, public transport, and television, offer a less expensive option for those seeking weight management solutions.
However, the proliferation of these copycat drugs might be temporary. As pharmaceutical giants Novo Nordisk and Eli Lilly work to ramp up production and alleviate shortages of their original products, the landscape for these less regulated alternatives may soon shift.
Understanding the Copycat Drugs
Unlike traditional generics, these off-brand drugs are classified as compounded medications. Prepared by pharmacists using ingredients sourced from FDA-registered suppliers, these drugs include semaglutide (the active ingredient in Wegovy and Ozempic) and tirzepatide (the active ingredient in Zepbound). These compounded versions are typically available through telehealth platforms and medical spas, requiring a prescription after an online consultation.
One significant advantage of these compounded drugs is their lower cost. For instance, Hims, a new player in the market, offers a month’s supply of semaglutide starting at $199, compared to approximately $1,300 for Wegovy alone. However, compounded drugs are not subjected to the FDA’s rigorous review process like generics. Instead, they are regulated primarily by state pharmacy boards, which may lead to potential issues with drug quality and safety.
Legal and Regulatory Landscape
Compounding pharmacies are allowed to produce these medications primarily due to shortages of FDA-approved drugs. When brand-name drugs are in short supply, compounded versions can legally enter the market. This situation is a direct result of the overwhelming demand that the original manufacturers have struggled to meet.
According to Robin Feldman, a law professor at the University of California, “Compounding pharmacies must navigate carefully around intellectual property laws and FDA regulations, but there are pathways they can follow.” Nonetheless, once the shortages of brand-name drugs are resolved, compounded versions may face significant restrictions.
Gail Bormel, acting director of the FDA’s Office of Compounding, notes that when shortages end, compounded pharmacies may no longer be permitted to produce these copies. Larger compounding organizations could be barred from making such versions altogether, while smaller ones may face limitations on production frequencies.
Potential for Adaptation
Compounding pharmacies may adapt by modifying their formulations to include additional elements, such as vitamins, to differentiate their products from the original drugs. This approach could help them navigate regulatory challenges and continue to offer alternatives.
Legal Actions and Industry Response
In response to the rise of these compounded drugs, Novo Nordisk and Eli Lilly have initiated lawsuits against several compounding companies. These legal battles involve issues such as unauthorized use of brand names in marketing and contamination concerns, which could damage the reputation of the original drugs.
As the shortages are addressed, the brand-name drugmakers are expected to shift their focus to patent infringement claims, aiming to protect their intellectual property and regain market dominance.
Telehealth companies like Hims and Ro, which have been active in selling compounded versions, have not provided specific details about how they plan to adjust their offerings once the shortages are resolved. The Alliance for Pharmacy Compounding indicates that while compounding pharmacists may face new restrictions, there will still be avenues for providing customized formulations that offer clinical benefits not available in commercial products.
In conclusion, the current surge in copycat weight loss drugs may be short-lived, as industry shifts and regulatory changes could soon alter the landscape of weight management solutions.
