OneSource Specialty Pharma secures SFDA approval for generic semaglutide in Saudi Arabia

OneSource Specialty Pharma announced that it has received approval from the Saudi Food and Drug Authority (SFDA) for its generic Ozempic (semaglutide) in Saudi Arabia. The approval enables the company to commercialise the product with Hikma Pharmaceuticals PLC as its exclusive commercialisation partner for the Middle East and North Africa (MENA).

The company stated that the approval marks its entry into the Kingdom of Saudi Arabia, which is among the largest markets for GLP-1 therapies. It added that the partnership aims to expand access to generic alternatives for patients across the region.

Under the agreement, OneSource will manufacture and supply semaglutide from its integrated biologics and drug-device combination facility in Bengaluru. Hikma Pharmaceuticals, which is the largest pharmaceutical company in the MENA region based on sales, will utilise its commercial network and institutional relationships to expand access across private and institutional channels.

Neeraj Sharma, CEO and MD, OneSource Specialty Pharma Limited, said: “We are extremely excited to secure SFDA approval for semaglutide in Saudi Arabia, one of the largest GLP-1 market globally with significant long-term potential. 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.”