Prestige Biopharma Obtains Marketing Authorization for 'Tuzuneu' in Trinidad and Tobago

Prestige Biopharma's Tuzuneu has received marketing authorization in Trinidad and Tobago.

According to Prestige Biopharma on September 18, this approval in Trinidad and Tobago is the first result following applications for marketing authorization submitted in five countries—Brazil, Colombia, Jamaica, Trinidad and Tobago, and Saudi Arabia—in 2024 and 2025, aimed at expanding their commercialization territory. Tuzuneu is a biosimilar of Swiss pharmaceutical company Roche's breast and gastric cancer treatment Herceptin, and represents Prestige Biopharma's first biosimilar pipeline.

Currently, reviews for marketing authorization of Tuzuneu are also underway in the remaining four countries: Brazil, Colombia, Jamaica, and Saudi Arabia. Prestige Biopharma plans to gradually expand the commercialization of Tuzuneu in Latin America, the Caribbean, and the Middle East, in line with the approval process progress in each country.

Prestige Biopharma anticipates that obtaining marketing authorization will have a positive impact on entry into other countries in these regions as well. Specifically, in Brazil, Prestige Biologics' manufacturing facility, where Tuzuneu is produced, obtained Good Manufacturing Practice (GMP) certification from Brazil's National Health Surveillance Agency (ANVISA) in August, thereby meeting the manufacturing facility requirements needed for regulatory approval.

Tuzuneu from Prestige Biopharma has been available in the European market through a licensing agreement with Teva, a global pharmaceutical company, after securing final marketing authorization from the European Commission (EC) in 2024.

A representative from Prestige Biopharma stated, "Starting with this approval in Trinidad and Tobago, we plan to expand our supply network in Latin America, the Caribbean, and the Middle East through subsequent marketing authorizations in the remaining countries," and added, "Having acquired ANVISA GMP certification in Brazil in August, we will proceed with future approval processes without delay."

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