Brazil Approves First Semaglutide Pen as EMS Challenges Novo Nordisk's Ozempic
Sao Paulo: Brazil's health regulator Anvisa said on Tuesday it had approved EMS's Ozivy, the country's first semaglutide-based injector pen, as the drugmaker looks to expand into a higher-end segment of the global pharmaceutical industry.
The drug uses the same active ingredient as Novo Nordisk's diabetes and weight-loss drug Ozempic, whose patent expired in Brazil in March.
Drug to be produced at EMS plant in Sao Paulo state with capacity for up to 40 million pens per year.
CEO of Grupo NC, which controls EMS, told Reuters in March the firm expected to launch semaglutide pens this year.
Following the registration, the drug will be marketed once Brazil's medicine pricing chamber approves a price cap.
For inclusion in Brazil's public healthcare system SUS, Ozivy must be approved by the Health Ministry.
Five other synthetic semaglutide applications and one biological version are under review by Anvisa.
EMS rival Hypera had previously said it also planned to launch its generic version of semaglutide this year.
