Prestige Biopharma’s Tuznue Secures Brazilian GMP Certification, Supporting Latin American Approval Process

Prestige Biopharma’s manufacturing facility for its Herceptin biosimilar Tuznue (TUZUNE) has obtained Good Manufacturing Practice (GMP) certification from Brazil’s National Health Surveillance Agency (ANVISA). The certification provides the manufacturing foundation needed to support the Brazilian marketing authorization process being pursued by its global commercialization partner, Dr. Reddy’s Laboratories, as well as the company’s broader expansion into Latin America.

Prestige Biopharma announced on August 25 that the Tuznue manufacturing facility had received ANVISA GMP certification. Following the product’s commercial launch in Europe, the company is seeking to expand into Latin America, with Brazil serving as a key entry market. Prestige Biopharma also aims to secure commercialization partners for the U.S. and Canadian markets within this year.

Tuznue is a biosimilar of Roche’s breast and gastric cancer treatment Herceptin, with trastuzumab as its active ingredient. The product is manufactured by Prestige Biopharma’s affiliate, Prestige Biologics.

In Brazil, Dr. Reddy’s has already submitted an application for marketing authorization for Tuznue. ANVISA GMP certification is one of the requirements associated with the local regulatory approval and commercial supply process, and Prestige Biopharma expects the certification to support the ongoing Brazilian approval procedure.

According to the company, Brazil accounts for approximately 40% of the total pharmaceutical market in Latin America, making it the region’s largest market. Prestige Biopharma plans to use its entry into Brazil as a springboard to gradually expand Tuznue sales into neighboring Latin American countries.

In Europe, Tuznue has already been launched and is being marketed through Teva Pharmaceutical Industries. Following its expansion into Latin America, Prestige Biopharma is also in discussions to secure partners for the U.S. and Canadian markets as part of its strategy to extend the product’s commercial reach into North America.

“This ANVISA GMP certification demonstrates that the commercialization of Tuznue in Latin America, which we have been pursuing together with Dr. Reddy’s, has progressed to a tangible stage,” said Lisa S. Park, Chairwoman of Prestige Biopharma. “We will accelerate our global market expansion by extending Tuznue’s commercialization from Europe into Latin America and by advancing commercialization partnerships in North America, including the United States and Canada, within this year.”

Source: PRESS9(https://www.press9.kr/news/articleView.html?idxno=81590)