OneSource Receives Saudi Approval for Generic Ozempic, Expanding Access in MENA Region
A new, more affordable option for patients requiring semaglutide is on the horizon, as OneSource Specialty Pharma has secured approval from the Saudi Food and Drug Authority (SFDA) to market its generic version of Ozempic in Saudi Arabia. This approval, coupled with a strategic partnership with Hikma Pharmaceuticals, promises to significantly broaden access to this vital medication across the Middle East and North Africa (MENA) region.
The SFDA’s decision marks a pivotal moment for OneSource, a contract development and manufacturing organization, as it establishes its presence in Saudi Arabia – a key market for GLP-1 therapies. The collaboration with Hikma is designed to deliver cost-effective alternatives to patients in a region where healthcare costs can be substantial.
Semaglutide is the active pharmaceutical ingredient in both Novo Nordisk’s popular diabetes drug, Ozempic, and its weight-loss counterpart, Wegovy. With a crucial patent on semaglutide set to expire in several markets this March, the landscape for generic competition is rapidly evolving.
Under the terms of the exclusive agreement, OneSource will handle the manufacturing and supply of semaglutide from its state-of-the-art integrated biologics and drug-device combination facility located in Bengaluru. Hikma, recognized as the largest pharmaceutical company in the MENA region by sales, will then utilize its extensive distribution network and established relationships to ensure widespread availability through both private and institutional healthcare channels.
“Securing SFDA approval for semaglutide in Saudi Arabia—one of the largest GLP-1 markets globally—has long-term potential,” stated a senior official at 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.”
This development arrives at a time of increasing demand for GLP-1 receptor agonists, driven by their efficacy in managing type 2 diabetes and aiding in weight loss. The introduction of a generic alternative is expected to alleviate pressure on healthcare systems and improve patient outcomes by making treatment more accessible.
The partnership between OneSource and Hikma represents a significant step towards democratizing access to essential medications in the MENA region, and could serve as a model for similar collaborations in other emerging markets. The approval, finalized on February 11, 2026, signals a new era of affordability and accessibility for patients seeking treatment with semaglutide.
