Samsung Bioepis’ Ontruzant 1st biosimilar to win WHO's PQ certification

Lee Han-soo  Published 2019.12.20  16:29  Updated 2019.12.20 17:30


Samsung Bioepis announced that Ontruzant, a trastuzumab biosimilar (Original: Herceptin), has become the first biosimilar to win the World Health Organization’s prequalification (PQ) certification.

Samsung Bioepis’ trastuzumab biosimilar Ontruzant

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.

In the past, WHO provided PQ certification only for vaccines. For the first time last year, however, it started a pilot PQ certification process for anti-cancer drugs using trastuzumab and rituximab.

Samsung Bioepis participated in the trastuzumab PQ certification in November last year and succeeded in obtaining the first PQ certification for trastuzumab.

The WHO’s PQ certification is a system, in which WHO assesses safety and effectiveness to supply medicines to developing countries through international organizations. It is an essential step in participating in international procurement bidding.

PQ-certified products are also qualified to speed up the marketing process in 41 countries, including the Philippines, Thailand, and Ukraine.

“The approval has given us a great opportunity to spread Ontruzant throughout the world via international organizations,” a company official said. “In the future, we will try to provide more patients with high-quality biopharmaceutical treatments at reasonable prices.”

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