Celltrion announced on July 31 that it completed the filing of a biologics license application (BLA) for its biosimilar Herzuma with the U.S. FDA on July 28 (local time). The process was started in May this year and related documents were examined for the past 60 days according to local rules. The final result of the examination by the FDA is scheduled for the first half of next year.
In April last year, the U.S. FDA approved of the sale of its biosimilar Remsima in the United States. Celltrion is planning to supply TEVA with Herzuma and Truxima, another one of its antibody biosimilar products, via Celltrion Healthcare once the U.S. FDA approves of the sale of the products. Then, TEVA becomes the first exclusive seller of Herzuma and Truxima in North America. The U.S. FDA accepted the BLA for Truxima in late June this year.
“Herzuma’s safety and effectiveness have already been proven and it has shown better clinical test results than the others on the market,” Celltrion explained, adding, “We will do our best so that a large number of people in the United States can benefit from it.”
The annual global sales of Herceptin, the original version of Herzuma, amount to 7.9 trillion won. Last year, the sales reached 3.48 trillion won in the U.S. market alone.