Herzuma, breast and stomach cancer treatment biosimilar developed by South Korea’s Celltrion Inc., has met World Health Organization (WHO) prequalification (PQ) standards, becoming the Korean drug maker’s second biosimilar to join medicine procurement bids by international organizations.

According to Celltrion on Monday, WHO has awarded Herzuma PQ certification, a WHO program that evaluates safety and efficacy of medicines and vaccines for supply to developing countries. Pharmaceutical companies must earn PQ certification to make a bid in global procurement by United Nations (UN) agencies.

The credit would give Celltrion upper hand in global medicinal product tenders in low-income countries by UN agencies.

With both Herzuma 150 milligrams and 420 milligrams on the WHO PQ list, Herzuma has become the second biosimilar of Celltrion with the WHO PQ certification. Celltrion’s Truxima, blood cancer treatment, in May received the WHO PQ, making it the world’s first rituximab biosimilar on the WHO PQ list.

Herzuma is a biosimilar of Herceptin (trastuzumab) developed by Genentech Inc., a subsidiary of F. Hoffmann-La Roche Ltd., and marketed by Roche. Herzuma is currently sold in the global market after it was granted marketing authorization by the European Medicines Agency (EMA) in February 2018 and by the U.S. Food and Drug Administration (FDA) in December.

Herzuma’s sales have been steadily growing in Europe, accounting for 19 percent of the original trastuzumab market in the fourth quarter of last year. Celltrion launched Herzuma in the United States in March through Teva Pharmaceuticals.

Celltrion’s marketing arm Celltrion Healthcare shares closed up 3.17 percent from the previous session at 97,500 won ($81.69) on Monday, while Celltrion shares finished the day 0.84 percent higher at 299,000 won.

By Kim Si-gyun and Lee Eun-joo

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