Celltrion's 'Herzuma' Obtains WHO Quality Certification

[Asia Economy Reporter Cho Hyun-ui] Celltrion announced on the 3rd that its breast cancer and gastric cancer treatment 'Herzuma' recently received prequalification (PQ) certification from the World Health Organization (WHO). This is the second product to receive WHO PQ certification following 'Truxima,' a biosimilar of rituximab for blood cancer, which was the first to be certified in May.

Celltrion explained that by securing certification for both Herzuma 150mg and 420mg simultaneously, it has established favorable conditions for international procurement tenders compared to global competing products. WHO PQ certification is an essential procedure for participating in international procurement market tenders supplying medicines to Africa and developing countries.

Herzuma is a biosimilar of the original drug 'Herceptin,' developed by Genentech of the multinational pharmaceutical group Roche and sold by Roche. Celltrion's Herzuma received marketing authorization from the European Medicines Agency (EMA) in February 2018 and approval from the U.S. Food and Drug Administration (FDA) in December 2018.

A Celltrion official stated, "With this WHO PQ certification as an opportunity, we will do our best to enter the procurement market so that Celltrion's oncology antibody biosimilar products can be provided to patients in underdeveloped countries at reasonable prices."

This content was produced with the assistance of AI translation services.