Celltrion announced on Aug. 3 that Herzuma, a breast and stomach cancer treatment, recently received a pre-qualification (PQ) certification from the World Health Organization (WHO).
This will be the second time for Celltrion to obtain WHO PQ certification after Truxima, the first blood cancer treatment certified by the WHO as a biosimilar of rituximab ingredients, in May.
WHO PQ certification is an essential procedure for participating in bidding for international procurement markets that supply medicines to Africa, developing countries and other countries.
In particular, as the company secured 150 mg and 420 mg of Herzuma certification at the same time, it will have favorable conditions for international procurement bids compared to its global competitors.
Herzuma is a biosimilar of the original drug "Herceptin" developed by Genentech of Roche Group, a multinational pharmaceutical company, and sold by Roche.
Celltrion Herzuma was approved by the European Medicines Agency (EMA) in February 2018 and the U.S. Food and Drug Administration (FDA) in December 2018 and is being sold in the global market.
In particular, it has been growing steadily with a 19% market share in Europe as of the fourth quarter of last year, and in the United States, its sales began in March through multinational pharmaceutical company Teva.
"This time, we have strengthened our bidding competitiveness in the international procurement market by obtaining certifications for various Herzuma products such as 150 mg and 420 mg. With this WHO PQ certification, we will do our best to enter the procurement market so that our anti-cancer antibody biosimilar products can be provided to patients in underdeveloped countries at reasonable prices," said an official at the company.
