OneSource Pharma-Hikma get regulatory approval to sell generic Ozempic in Saudi Arabia

Contract drug manufacturer OneSource Specialty Pharma received approval for its generic version of Ozempic in Saudi Arabia, clearing the path for selling the type-2 diabetes and weight-loss drug with its partner Hikma Pharmaceuticals PLC.

Hikma is OneSource’s exclusive commercialization partner for the Middle East and North Africa (MENA). The approval from the Saudi Food and Drug Authority (SFDA) will enable its entry into Saudi Arabia, one of the largest markets for Ozempic and other weight management/loss drugs.

The exclusive partnership will help the company “capitalize on rising demand for this product” and underscores the ambition of both companies to increase access to high-quality affordable generic drug alternatives for patients across the region, OneSource said in a statement on Wednesday.

Under the agreement, OneSource will manufacture and supply semaglutide from its facility in Bengaluru and Hikma will use its commercial reach and institutional relationships in the region to widen availability of the drug.

“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 across both private and institutional customers,” chief executive officer and managing director Neeraj Sharma said in the statement.

Global boom

OneSource is gearing up to cash in on the massive demand for generic semaglutide pens as innovator Novo Nordisk is set to lose patent exclusivity in over 80 countries this year for the drug, known by brands Ozempic and Wegovy.

Sharma told Mint in November that OneSource is fast-tracking a $100 million capacity expansion to tap into the global boom in weight-loss drugs. He said the company is prepared for the market expansion in terms of manufacturing and regulatory approvals for its facilities.

As a contract manufacturer, OneSource’s gains depend on partners getting approvals on time. In Q3, its revenue dropped 26% YoY to ₹290.3 crore ($33.1 million) after semaglutide approvals were delayed in Canada, where the patent has expired.

Its Ebitda dropped 88% and the Ebitda margin contracted to 6% from 36% a year earlier. The firm is targeting $500 million in revenue by FY28, Sharma told Mint in November.