Drugmaker Sun Pharmaceutical Industries has received the green signal from the South African Health Products Regulatory Authority (SAHPRA) to manufacture and market a generic version of semaglutide injection in South Africa for the treatment of adults with inadequately controlled type 2 diabetes mellitus, the company said. The Mumbai-based drugmaker expects to launch the product shortly.
The development comes even as Dr Reddy’s Laboratories recently said, its supplies to Canada would be delayed following an “out of specification” issue with certain batches that the company wanted to address.
“South Africa is the second market after India where Sun Pharma has received approval for generic semaglutide,” said Aalok Shanghvi, Sun Pharma’s Chief Operating Officer, adding that it reflected the company’s ability to develop complex and quality generic medicines for different markets. Sun’s semaglutide version will be available as a pre-filled, multi-dose injectable pen in two strengths (2 mg/1.5 mL and 4 mg/3 mL) that allow flexible, once-weekly dosing, it said.
South Africa faces a growing burden of type 2 diabetes, driven in part by rapid urbanization and changing lifestyles, a note from the company said. Sun Pharma, Dr Reddy’s and others had launched their generic versions of semaglutide in India, late March, after a patent on the product expired in India and other markets. Semaglutide is the active ingredient in weightloss and diabetes drugs Wegovy and Ozempic, from the Novo Nordisk stable.