OneSource Pharma Secures Saudi Approval for Generic Ozempic in Strategic Hikma Partnership
Contract drug manufacturer OneSource Specialty Pharma has achieved a significant milestone by receiving approval from the Saudi Food and Drug Authority (SFDA) for its generic version of Ozempic. This clearance paves the way for the sale of the type-2 diabetes and weight-loss medication in Saudi Arabia, one of the largest markets for such drugs in the Middle East and North Africa (MENA) region.
Exclusive MENA Partnership with Hikma Pharmaceuticals
Hikma Pharmaceuticals PLC serves as the exclusive commercialization partner for OneSource in the MENA region. This collaboration is designed to leverage Hikma's extensive commercial reach and institutional relationships to distribute the generic semaglutide widely. In a statement released on Wednesday, OneSource emphasized that the exclusive partnership will enable the company to "capitalize on rising demand for this product" and aligns with both firms' goals to enhance access to high-quality, affordable generic alternatives for patients across the region.
Under the terms of the agreement, OneSource will manufacture and supply the semaglutide from its facility located in Bengaluru, India. Meanwhile, Hikma will utilize its established market presence to ensure the drug's availability reaches both private and institutional customers. Neeraj Sharma, chief executive officer and managing director of OneSource, expressed confidence in the partnership, stating, "We are confident that 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."
Capitalizing on Global Demand and Patent Expirations
OneSource is strategically positioning itself to benefit from the surging global demand for generic semaglutide pens. This opportunity arises as innovator Novo Nordisk is set to lose patent exclusivity for Ozempic and Wegovy in over 80 countries this year. To prepare for this expansion, OneSource is accelerating a $100 million capacity expansion initiative aimed at tapping into the weight-loss drug boom.
Sharma highlighted in a November interview with Mint that the company is fully prepared in terms of manufacturing capabilities and regulatory approvals for its facilities. However, as a contract manufacturer, OneSource's success hinges on timely approvals from partners. This was evident in the third quarter, when revenue declined by 26% year-over-year to ₹290.3 crore ($33.1 million) due to delays in semaglutide approvals in Canada, where the patent has already expired.
During the same period, Ebitda plummeted by 88%, and the Ebitda margin contracted sharply to 6% from 36% a year earlier. Despite these challenges, OneSource remains ambitious, targeting $500 million in revenue by the fiscal year 2028, as Sharma confirmed in the November discussion.
Market Implications and Future Prospects
The SFDA approval marks a critical step for OneSource in entering the lucrative Saudi market, which is a key hub for weight management and loss drugs. This move not only strengthens the company's foothold in the MENA region but also underscores the growing trend towards affordable generic alternatives in healthcare. With Hikma's support, OneSource aims to navigate the competitive landscape and meet the escalating demand for effective weight-loss solutions, potentially reshaping access to such therapies across the Middle East and North Africa.
