Brazil’s health regulator, Anvisa, approved the registration of five new semaglutide injection pens on Wednesday (29). The decision marks the entry of Brazilian pharmaceutical company Hypera, Switzerland’s Sandoz, and India’s Sun Pharma into the market for the molecule used in weight-loss pens made by Denmark’s Novo Nordisk, the manufacturer of Ozempic and Wegovy. Brazil has now approved six new medicines since the active ingredient lost exclusivity in March
The arrival of three competitors intensifies the battle for consumers in a market that generated R$5.6 billion in sales last year, according to data from the Brazilian Association of National Pharmaceutical Laboratories (Alanac) and IQVIA. Combined with tirzepatide—the active ingredient in Mounjaro, made by U.S.-based Eli Lilly—the market is expected to reach R$35 billion by 2030, according to a recent Itaú BBA report
The newly registered pens use synthetic semaglutide and are not classified as generics. Brazilian law does not permit generic versions of biological products such as Ozempic. The pens were classified as new medicines and synthetic alternatives to the biological product, as was Ozivy, EMS’s semaglutide pen and the first to receive registration in Brazil
All are indicated for diabetes treatment, although Hypera said it is studying higher doses indicated for obesity
The registrations were issued for two brands controlled by the Brazilian pharmaceutical company: Semavy and Zempneo. Hypera said Semavy should reach pharmacies within two months, while there are no short-term plans to launch Zempneo
“[Semavy] has the potential to become one of Hypera’s main products, given the size of this market,” CEO Breno de Oliveira told Valor. The product was developed through a partnership with Sun Pharma, which will manufacture the medicine in India. It will join the portfolio of Mantecorp, a Hypera brand focused on primary care across various medical specialties and prescription medicines. Oliveira said the medicine could be kept outside the refrigerator after use begins. “In that respect, it is the same as Ozempic.”
Analysts covering Hypera said the pharmaceutical company is well positioned to capture the potential of the semaglutide market
Santander estimates that Semavy could add between 3% and 4% to Hypera’s earnings before interest, taxes, depreciation, and amortization (EBITDA) in 2027 and 2028. Itaú BBA said that although Semavy will arrive alongside new competitors, it could generate stronger sales because of Hypera’s distribution reach among doctors and pharmacy chains. Citi, meanwhile, expressed caution about the risk of price erosion and said investors might question the implications of the Sun Pharma partnership, given that the Indian company also obtained two registrations of its own.
One Sun Pharma registration was issued to its Brazilian subsidiary for a product called Seemasun. The other went to Ranbaxy, a pharmaceutical company owned by Sun Pharma, whose product was named Orsema. In a press release, Sun Pharma said its partnership with Hypera strengthens its diabetes portfolio in Brazil. When contacted, however, the company did not say when it expects to launch the medicines under its own licenses
Sandoz’s semaglutide medicine, developed through partnerships with Ávita Care and Maltese pharmaceutical company Adalvo, is called Owozy. Adalvo will manufacture the medicine in Canada, while Sandoz will import and market it in Brazil under its own label. Ávita, Adalvo’s local representative in the regulatory process, submitted the registration application
“We are now responsible for bringing this molecule to market, while Adalvo owns the technology and is responsible for developing and manufacturing the molecule,” said Isabella Wanderley, president of Sandoz’s Brazilian subsidiary and a former general manager at Novo Nordisk
The Swiss company’s entry into the GLP-1 analog market establishes Sandoz’s third global business line alongside its current focus on generics and biosimilars. Brazil will be the first country to receive the company’s semaglutide pen
Wanderley said the medicine is expected to reach pharmacies between September and October. It can also be kept outside the refrigerator at temperatures of up to 30 degrees Celsius for up to 42 days after the first injection
The new competitors’ production model differs from Ozivy’s, which EMS manufactures in Brazil. Sandoz and Hypera said they currently have no plans to localize production in Brazil but are assessing the market
“Entering this segment alone increases the likelihood of an eventual decision to manufacture locally, although some pharmaceutical companies may have chosen the partnership model to test the market first,” said Reginaldo Arcuri, president of the FarmaBrasil Group
Arcuri said approvals for new medicines help combat informal sales. The unregulated and untraceable market for tirzepatide—including imports from Paraguay and compounded products—generated R$12.5 billion during the 12 months through April, according to Itaú BBA
Both Sandoz and Hypera said their medicines should cost less than Ozempic but remain within the same price range as EMS’s Ozivy, which currently costs between R$452 and R$497 for doses ranging from 0.25 mg to 1 mg
(Felipe Laurence, Victor Meneses, and Adriana Peraita contributed reporting.)
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