Saudi Arabia has approved a generic version of semaglutide, the active ingredient in the popular diabetes and weight-loss medications Ozempic and Wegovy. The approval, granted to OneSource Specialty Pharma, paves the way for commercialization in partnership with Hikma Pharmaceuticals PLC, with a focus on the Middle East and North Africa (MENA) region. This development signals increased access to a more affordable alternative to the branded medications, particularly in a region with a growing prevalence of type 2 diabetes and obesity.
The Saudi Food and Drug Authority (SFDA) approval, announced on , marks OneSource’s entry into the Saudi Arabian pharmaceutical market, which is one of the largest globally for GLP-1 receptor agonist therapies – the class of drugs to which semaglutide belongs. These therapies work by mimicking a natural hormone that regulates blood sugar and appetite, making them effective for managing type 2 diabetes and, increasingly, for weight loss.
Under the terms of the exclusive agreement, OneSource will handle the manufacturing of semaglutide at its facility in Bengaluru, India. Hikma, described as the largest pharmaceutical company in the MENA region by sales, will leverage its established distribution network and relationships with healthcare providers and institutions to ensure broad access to the generic medication across both private and public healthcare sectors.
“Securing SFDA approval for semaglutide in Saudi Arabia—one of the largest GLP-1 markets globally—has long-term potential,” stated Neeraj Sharma, Chief Executive Officer and Managing Director of OneSource. “Collaborating with Hikma, the largest pharmaceutical company in the MENA region by sales, will give us a strong platform to scale access to this important therapy.”
The timing of this approval is significant. A key patent protecting semaglutide is set to expire in several markets this March, opening the door for generic manufacturers like OneSource to enter the market. This patent expiration is expected to drive down the cost of the medication, making it more accessible to a wider patient population. The high cost of Ozempic and Wegovy has been a barrier to access for many individuals, even those with insurance coverage.
GLP-1 receptor agonists have gained considerable attention in recent years, not only for their efficacy in managing type 2 diabetes but also for their demonstrated weight-loss benefits. Wegovy, specifically, is approved for chronic weight management in adults with obesity or overweight with at least one weight-related condition. The increasing demand for these medications has, at times, led to supply shortages, further highlighting the need for affordable generic alternatives.
The partnership between OneSource and Hikma is designed to address this need. By combining OneSource’s manufacturing capabilities with Hikma’s regional expertise, the companies aim to provide a reliable and cost-effective supply of semaglutide to patients throughout the MENA region. Here’s particularly important in countries like Saudi Arabia, where rates of diabetes and obesity are rising, placing a significant burden on healthcare systems.
The approval process for generic medications is rigorous, requiring manufacturers to demonstrate that their product is bioequivalent to the branded version. This means that the generic medication must be absorbed and utilized by the body in the same way as the original drug. The SFDA approval confirms that OneSource’s generic semaglutide meets these stringent standards.
While the availability of a generic semaglutide is a positive development for patients and healthcare systems, it’s important to remember that these medications are not without potential side effects. Common side effects include nausea, vomiting, diarrhea, and constipation. Patients should discuss these potential risks with their healthcare provider before starting treatment. Semaglutide is not a quick fix for weight loss or diabetes management. it should be used in conjunction with lifestyle modifications, such as a healthy diet and regular exercise.
The expansion of access to affordable semaglutide in the MENA region represents a significant step towards improving the health and well-being of individuals living with type 2 diabetes and obesity. The collaboration between OneSource and Hikma demonstrates a commitment to addressing unmet medical needs and providing patients with access to essential medications.