Samsung Bioepis’ biosimilar breast cancer treatment scores FDA’s nod

In Clinical Studies News by Barbara Jacoby


Samsung Bioepis said Friday that the U.S. Food and Drug Administration has granted sales approval for Ontruzant 420mg, a trastuzumab biosimilar (Original: Herceptin).

Ontruzant treats patients with early breast cancer, metastatic breast cancer, and metastatic gastric cancer. Its original, Herceptin, is one of the world’s most purchased medicines, with an annual sale of 7.2 trillion won ($5.7 billion) in 2019.

The company received regulatory approval for Ontruzant 150mg, the same dose as its original Herceptin, in January 2019.

Samsung Bioepis said it has been pursuing a large-scale product license to meet various prescription needs of doctors and patients.

The Korean company is preparing to launch Ontruzant in the U.S. through MSD, its U.S marketing partner, as the authorization of large-capacity products has provided a marketing portfolio that can keep up with market competition from multinational pharmaceutical companies.

The company has also resolved a patent dispute with Herceptin’s developer, Genentech, last year, dissolving uncertainty concerning the product’s launch.

Due to the terms of the contract, however, the company has yet to disclose the timing of its launch.

“As confirmed through the European market, trastuzumab-based pharmaceutical products have various prescription needs,” a company official said. “Therefore, we will showcase the large-scale product to the market to provide more effective treatment opportunities for patients.”

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