Tuznue Won Brazil Approval a Month After Its Plant Passed Anvisa Inspection, Nearly 20 Months After Filing
- Prestige BioPharma said on 28 September 2026 that Brazil’s Anvisa has approved Tuznue (trastuzumab), its biosimilar of Roche‘s Herceptin, in 150 mg and 440 mg formulations, Korea Biomedical Review reported. Dr. Reddy’s Laboratories holds the Brazilian registration and will handle marketing, sales and supply under an exclusive licence.
- The approval follows Prestige’s announcement on 25 August that the Tuznue plant, run by its affiliate Prestige Biologics, had received Anvisa GMP certification, which the company described as a requirement of the approval process. Dr. Reddy’s filed in Brazil in February 2025, when Prestige expected a decision that year.
- Brazil is Tuznue’s second approval among 5 countries where Prestige filed in 2024 and 2025, after Trinidad and Tobago. Prestige puts Brazil at about 40% of the Latin American pharmaceutical market and valued the Brazilian trastuzumab market at more than $206m a year in 2025.
- In Europe, Tuznue was approved in September 2024, two years after the CHMP recommended refusal in May 2022, and is sold by Teva under an October 2025 licence. Biosidus holds rights in Argentina and other Latin American markets, and Prestige says it aims to sign US and Canadian partners this year.
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In Brazil the constraint was not the dossier. It was the factory.
- Inspection set the pace. Prestige expected a Brazilian decision in 2025; it came about a month after Anvisa certified the manufacturing site. For biosimilar developers planning Brazilian entry, site certification is the step to schedule around, not the clinical package.
- Dr. Reddy’s is becoming the route into emerging markets for other companies’ products. In the past week Synopulse has covered it launching its own nivolumab biosimilar and distributing Takeda’s QDENGA in India, extending Gilead’s lenacapavir licence, and now holding Brazilian registration for a Singapore-based developer’s trastuzumab.
- A partner-built footprint with a gap in North America. Prestige relies on Teva in Europe, Dr. Reddy’s in Brazil and Biosidus in Argentina, and still has no US or Canadian partner. It would enter a US market where rival trastuzumab biosimilars are already established, which makes the partner’s terms more important than the approval.