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

Contract drugmaker OneSource Specialty Pharma has won approval for a generic version of Ozempic in Saudi Arabia, paving the way for sales of 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 allow Ozempic and other weight management/loss drugs to enter Saudi Arabia, one of its largest markets.

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

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

“We are confident that collaborating with Hikma, the MENA region’s largest pharmaceutical company by sales, will provide us with a strong platform to scale access to this important treatment across both private and corporate customers,” chief executive officer and managing director Neeraj Sharma said in a statement.

global explosion

OneSource is poised to meet huge demand for generic semaglutide pens as innovator Novo Nordisk will lose patent exclusivity in more than 80 countries this year for the drug, known by the brands Ozempic and Wegovy.

sharma told Mint In November, OneSource is accelerating a $100 million capacity expansion to capitalize on the global boom in weight-loss drugs. He said the company is ready for market expansion in terms of production and regulatory approvals for its facilities.

As a contract manufacturer, OneSource’s gains depend on its partners receiving approvals in a timely manner. Revenue fell 26% year over year in the third quarter ₹290.3 crore ($33.1 million) after approvals for semaglutide were delayed in Canada, where the patent had expired.

Its EBITDA fell 88% and its EBITDA margin fell to 6% from 36% the previous year. Sharma said the firm is targeting $500 million in revenue by FY28 Mint In November.