South Korea’s biosimilar maker Celltrion Inc. announced Wednesday its blood cancer therapy Truxima has received the World Health Organization (WHO) Prequalification (PQ), making it the world’s first rituximab biosimilar on the WHO PQ list.

The WHO PQ, a service provided by the global health body to test the safety and efficacy of medicinal products, is a crucial step before they are available in low-income countries.

The process had been required for vaccines only, but the WHO introduced prequalification for cancer meds such as trastuzumab and rituximab in 2018. With the certification, Celltrion will be able to join drug tenders for Truxima by international organizations under the United Nations and to provide it to developing countries.

With the WHO PQ, Truxima hopes to help significantly lower the cost of treating patients with blood cancer in underdeveloped countries and increase their recovery, said Celltrion’s spokesperson, adding the company will be committed to more treatment opportunities for more patients at reasonable prices.

Celltrion is awaiting another WHO PQ for its breast and stomach cancer med Herzuma (trastuzumab), a Herceptin biosimilar. An announcement is due to come between July and September.

Among Korean-made biosimilars, Ontruzant, a breast cancer med from Samsung Bioepis, received the WHO PQ last December.

By Kim Byung-ho and Minu Kim

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