Prestige Biopharma’s Tuznue Receives Marketing Authorization in Trinidad and Tobago

Prestige Biopharma announced that its biosimilar Tuznue has received marketing authorization in Trinidad and Tobago.

According to Prestige Biopharma on September 18, the approval marks the first regulatory success among five countries—Brazil, Colombia, Jamaica, Trinidad and Tobago, and Saudi Arabia—where the company submitted marketing authorization applications in 2024 and 2025 as part of its efforts to expand the global commercialization of Tuznue.

Tuznue is a biosimilar of Roche’s Herceptin, a treatment for HER2-positive breast and gastric cancers, and represents Prestige Biopharma’s first biosimilar pipeline product.

Marketing authorization reviews are currently underway in the remaining four countries: Brazil, Colombia, Jamaica, and Saudi Arabia. Prestige Biopharma plans to gradually expand the commercialization of Tuznue across Latin America, the Caribbean, and the Middle East in line with regulatory progress in each country.

The company expects that approvals in these markets could also have a positive impact on its expansion into other countries within the respective regions. In Brazil, Prestige Biologics’ manufacturing facility for Tuznue received Good Manufacturing Practice (GMP) certification from Brazil’s National Health Surveillance Agency (ANVISA) in August, fulfilling the manufacturing facility requirements necessary for the marketing authorization process.

Tuznue received final marketing authorization from the European Commission (EC) in 2024 and has since been launched and marketed in Europe through a licensing agreement with global pharmaceutical company Teva.

A Prestige Biopharma official said, “Starting with the approval in Trinidad and Tobago, we plan to expand our supply network across Latin America, the Caribbean, and the Middle East through sequential marketing authorizations in the remaining countries. Following the ANVISA GMP certification obtained in Brazil this August, we will continue to proceed with the remaining regulatory procedures without disruption.”

Source: Asia Economy (https://view.asiae.co.kr/article/2026091809382068983)