Brazil’s Agencia Nacional de Vigilancia Sanitaria has granted marketing authorization for Samsung Bioepis’ Ontruzant, a trastuzumab biosimilar (Original: Herceptin), the company said Monday.

Samsung Bioepis’ trastuzumab biosimilar Ontruzant

The approval comes 13 months after the company submitted its biologics license application to the Brazilian health authority in December 2017.

Ontruzant is used to treat patients with early breast cancer, metastatic breast cancer and metastatic gastric cancer, and was the first trastuzumab biosimilar to receive regulatory approval in Europe. Its original, Herceptin, is one of the world’s most purchased medicines with an annual sale of $6.9 billion in 2015.

Brazil’s marks the fourth approval for Bioepis’ Ontruzant following those by Korea, U.S., and EU.

“With the sales approval of our product in Brazil, the company has once again proved its global technology competence,” a company official said. “As Brazil is the largest market in Latin America, we expect further opportunities for treatment with high-quality biopharmaceuticals.”

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