Prestige Biopharma Receives Brazilian Marketing Authorization for Herceptin Biosimilar Tuznue

Prestige Biopharma announced on September 28 that its Herceptin biosimilar, Tuznue, has received marketing authorization from Brazil’s National Health Surveillance Agency (ANVISA). The approved dosage strengths are 150 mg and 440 mg.

Tuznue is a biosimilar of Herceptin, Roche’s treatment for breast and gastric cancers, and is Prestige Biopharma’s first biosimilar pipeline product. According to the company, the Brazilian approval marks the second marketing authorization obtained in the Latin American region, following Trinidad and Tobago.

Brazil is the largest pharmaceutical market in Latin America, accounting for approximately 40% of the region’s total pharmaceutical market. Prestige Biopharma plans to launch and commercialize Tuznue in Brazil under an exclusive licensing agreement with Dr. Reddy’s, the local marketing authorization holder. Dr. Reddy’s will be responsible for local marketing, sales, and product supply.

Lisa S. Park, Chairwoman of Prestige Biopharma, said, “The marketing authorization in Brazil represents an important milestone in expanding the global commercialization of Tuznue. In collaboration with Dr. Reddy’s, we will move forward with the launch and sales of Tuznue in Brazil and, building on this achievement, continue to expand the product’s presence across the Latin American market.”

Meanwhile, Prestige Biopharma submitted marketing authorization applications for Tuznue in five countries — Brazil, Colombia, Jamaica, Trinidad and Tobago, and Saudi Arabia — in 2024 and 2025. With the latest approval in Brazil, Tuznue has now received marketing authorization in two of the five countries.

Source: NewsPim (https://www.newspim.com/news/view/20260928000094)