SAO PAULO, May 26 (Reuters) – 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 […]
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Brazil approves first generic semaglutide pen after Ozempic patent expiry
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SAO PAULO, May 26 (Reuters) – 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.
(Reporting by Isabel Teles and Gabriel Araujo; Editing by Paul Simao)