Prestige Biopharma is betting on Brazil as its gateway into Latin America’s biosimilar market. 

The Korean biosimilar developer said Tuesday that its partner, Dr. Reddy’s Laboratories, has submitted a marketing authorization application for Tuznue, its trastuzumab biosimilar, to Brazil’s National Health Surveillance Agency (Anvisa).

The filing marks Prestige Biopharma’s first regulatory step in Latin America and, if approved, could significantly expand its market reach. 

Tuznue, a biosimilar of Genentech’s blockbuster drug Herceptin, is approved for HER2-positive early breast cancer, metastatic breast cancer, and advanced gastric cancer. In Brazil, breast cancer is the most common cancer among women, with over 60,000 new cases diagnosed annually. 

Yet access to high-cost biologics remains uneven, a Prestige Biopharma official said, making biosimilars an increasingly attractive option as the government aims to reduce healthcare costs while improving treatment access.

Dr. Reddy’s, a multinational pharmaceutical company headquartered in India, will oversee the commercialization of Tuznue across eight key Latin American countries, including Brazil, Mexico, Argentina, Chile, and Venezuela, as well as the entire Asian region, including India.

The Brazilian trastuzumab market is valued at over 300 billion won ($206 million) annually, making it a key market for Prestige Biopharma’s expansion in the region.

“Brazil is the most important market for our expansion strategy,” the Prestige Biopharma official said. “Once regulatory approval is secured, it will facilitate entry into neighboring countries, some of which recognize Brazil’s regulatory decisions.” 

The regulatory process in Brazil typically takes about a year, though in some cases, it can extend to 13 months. Prestige Biopharma said it expects a decision in 2025 and is working closely with Dr. Reddy’s to expedite the approval process.

Once approved, production will begin. The manufacturing of the drug substance will be handled by Prestige Biologics, the company’s contract development and manufacturing organization (CDMO). Prestige Biopharma said it has been preparing for large-scale production in anticipation of commercialization.

“To establish a competitive market presence, we are prioritizing cost efficiency and strategic partnerships,” the company official said. “As Tuznue, our first biosimilar, begins sales across multiple regions, we expect to achieve significant revenue growth this year.”

Prestige Biopharma is securing regulatory approvals and commercial partnerships across multiple regions. In Europe, Tuznue received approval last year, and the company is currently finalizing distribution agreements. Regulatory applications are also under review in the Middle East and Russia, where final evaluations are ongoing.