Prestige Biopharma's Tuznue Receives GMP Certification from Brazilian Health Regulatory Agency
Prestige Biopharma's production facility for Tuznue has received Good Manufacturing Practice (GMP) certification from the Brazilian Health Regulatory Agency (ANVISA).
According to Prestige Biopharma on August 25, Tuznue is a biosimilar of Roche’s Herceptin (active ingredient: trastuzumab), which is used for breast and gastric cancer, among others. Production is handled by Prestige Biologics, an affiliate of Prestige Biopharma. With this certification, the company's push to enter the Brazilian and broader Latin American markets in partnership with its global commercialization partner, Dr. Reddy's, is expected to accelerate.
Brazil is the largest pharmaceutical market in Latin America, accounting for about 40% of the region’s total market. ANVISA’s GMP approval is a key milestone for pharmaceutical product registration and commercial supply within Brazil. Following this approval, the process for Tuznue’s product registration in Brazil, which was submitted by Dr. Reddy's, is expected to gain momentum. Prestige Biopharma plans to gradually expand the sales region of Tuznue to neighboring Latin American countries, starting with entry into Brazil.
Prestige Biopharma also plans to expand Tuznue’s commercialization to the North American market after Latin America. The firm is in discussions to secure partners in the United States and Canada by the end of the year. In Europe, Tuznue has been launched through global pharmaceutical company Teva Pharmaceutical, and sales are growing. Prestige Biopharma will continue to expand Tuznue’s sales channels based on regional global partnerships.
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Soyoun Park, Chairwoman of Prestige Biopharma, said, “This ANVISA GMP certification marks meaningful progress in the commercialization of Tuznue in Latin America together with Dr. Reddy's. We will accelerate global market expansion by extending Tuznue's commercialization from Europe to Latin America, and by finalizing commercialization partnerships in North America—including the United States and Canada—within this year.”
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