The arrival of semaglutide—the active ingredient in Novo Nordisk’s blockbuster drugs Ozempic and Wegovy—has been hailed as a paradigm shift in the treatment of type 2 diabetes and obesity. For many patients in Chile, these medications represent a lifeline for metabolic health. However, a growing conflict between local health regulators and pharmaceutical experts suggests that while the innovation has arrived, the affordability of the treatment remains locked behind a regulatory bottleneck.
At the center of the dispute is the Instituto de Salud Pública (ISP), Chile’s public health authority and its criteria for approving generic versions of the drug. While global regulatory benchmarks, including the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA), generally treat semaglutide as a synthetic molecule for registration purposes, the ISP has maintained a more rigid classification. This distinction is not merely academic; it determines whether a generic manufacturer can enter the market via a streamlined process or must undergo a grueling, costly registration from scratch.
As a physician, I have seen how the “biologic versus synthetic” debate can dictate patient access. When a drug is classified as a biologic, the requirements for “biosimilars” are significantly more stringent than those for “generics.” In Chile, this technical friction is delaying the entry of lower-cost alternatives, effectively extending the market exclusivity of the innovator drug even after patents have expired.
The Technical Divide: Biological vs. Synthetic
Semaglutide is a GLP-1 (glucagon-like peptide-1) receptor agonist. It is designed to mimic a natural hormone that regulates insulin secretion and appetite. However, it is not a natural hormone; it is a chemically modified molecule engineered to be more stable and longer-lasting in the human body than the natural GLP-1 peptide.
Because of this modification, the FDA and EMA treat it as a synthetic product. This allows generic manufacturers to pursue a “simplified” registration path, focusing on bioequivalence—proving that the generic version delivers the same amount of active ingredient into the bloodstream at the same rate as the original.
The ISP, however, has categorized semaglutide as a product of biological origin. Under this classification, generic developers are forced into a “regular registration” process. This requires them to treat the generic as a brand-new drug, often necessitating expensive and time-consuming clinical trials that global agencies deem unnecessary for a known active ingredient.
| Regulatory Path | FDA / EMA Approach | Chilean ISP Approach |
|---|---|---|
| Classification | Synthetic / Chemically Modified | Biological Origin |
| Registration Type | Simplified / Bioequivalent | Ordinary / Full Registration |
| Requirement | Bioequivalence studies | Full clinical trials/New product data |
| Market Entry | Faster, lower cost | Slower, high investment |
A Public Health Crisis in the Balance
The stakes of this regulatory debate are amplified by Chile’s current health landscape. According to data from the OECD, Chile leads the world in the prevalence of overweight individuals, with 70.2% of the population affected. Chile ranks second globally in obesity rates for those over 14 years old (30.7%), trailing only the United States. Between 2013 and 2023, obesity rates in the country surged by 204%.
For a population facing an obesity epidemic, the cost of Ozempic and Wegovy can be prohibitive. Critics argue that by imposing “hidden hurdles” on generics, the ISP is inadvertently protecting the profit margins of the innovator pharmaceutical company at the expense of public health. Jorge Cienfuegos, former president of the College of Pharmaceutical Chemists and current director at the Universidad Academia de Humanismo Cristiano, has questioned why an agency that identifies as the “Chilean FDA” would deviate so sharply from the FDA’s own standards.
“It is difficult to find a logical sense,” Cienfuegos noted, pointing out that the ISP is a Level 4 regulatory agency under the Pan American Health Organization (PAHO), meaning its decisions often influence the broader region. When the ISP diverges from international norms, it doesn’t just leisurely down local production; it creates a regional anomaly in drug access.
The Argentina Contrast: A Model for Access
The impact of a “synthetic” classification is clearly visible in neighboring Argentina. There, the regulatory body adopted a view similar to the FDA, treating semaglutide as a synthetic product. This allowed the laboratory ELEA to successfully register and market two generic versions of the drug.
The results in Argentina provide a stark contrast to the Chilean experience. María Eugenia Provenzano, Manager of Regulatory Affairs at ELEA, reports that since the launch of their generic semaglutide over a year ago, patient access has quadrupled—growing from 30,000 to 120,000 patients. Currently, more than 70% of patients in Argentina utilizing this treatment use the generic version rather than the innovator drug.
Heriberto García, a former director of the ISP and current professor at Universidad del Desarrollo, argues that Chile should align its vision with this global and regional trend. He maintains that there is no scientific justification for requiring full clinical trials for a molecule that has already been proven safe and effective globally.
The ISP’s Defense: Legal Constraints
When questioned, the ISP defended its position by citing the legal framework of Decree 3, which regulates pharmaceutical products for human use. The agency explained that current semaglutide products are registered as biologicals by nature, and any generic that does not meet the specific requirements of Article 52—which governs simplified procedures—must undergo ordinary registration.
The ISP maintains that this approach is designed to “adapt to the origin of the product to guarantee safety.” the agency clarified that the criteria for sanitary registration are established by Supreme Decree, meaning the ISP does not have the unilateral authority to change the classification of these drugs without a legislative or executive shift.
Despite the friction, the ISP insists that multiple registration processes for semaglutide are currently underway and are moving through “standard times.” They have expressed hope that these resolutions will soon increase the availability of alternatives in the market.
Disclaimer: This article is for informational purposes only and does not constitute medical advice. Patients should always consult with a licensed healthcare provider before starting or switching medications.
The next critical checkpoint for Chilean patients will be the upcoming resolutions on the pending generic registrations currently under review by the ISP. While the agency has not provided a specific date, the industry is watching closely to see if the “ordinary registration” path will finally yield the first approved bioequivalents, or if the regulatory deadlock will persist.
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