Brazil’s health regulatory agency Anvisa announced Tuesday that it has cleared EMS’s Ozivy, marking the first semaglutide injection pen approved in the country as the pharmaceutical company seeks to enter a more premium market segment.
The medication contains the same active compound found in Novo Nordisk’s diabetes and weight-loss treatment Ozempic, which lost patent protection in Brazil this past March.
Production of the drug will take place at an EMS facility located in Sao Paulo state, with manufacturing capability reaching as many as 40 million injection pens annually.
The CEO of Grupo NC, EMS’s parent company, had previously informed Reuters in March that the company anticipated bringing semaglutide pens to market during this year.
While regulatory approval has been secured, the medication cannot be sold until Brazil’s medicine pricing authority establishes a maximum price point.
To become part of Brazil’s government-run healthcare program SUS, Ozivy requires additional clearance from the Health Ministry.
Anvisa is currently evaluating five additional synthetic semaglutide submissions along with one biological variant.
Competing pharmaceutical company Hypera had also announced intentions to introduce its own generic semaglutide product this year.
