US FDA Approves Celltrion’s Biosimilar to AG’s Breast Cancer Subset Herceptin

Celltrion Inc. announced on December 15 that the US Food and Drug Administration (US FDA) had approved Herzuma, a biosimilar to Roche Holding AG’s blockbuster breast cancer treatment, Herceptin (proper name: trastuzumab), on the 14th.

Herceptin is the world’s most successful antibody drug that generates sales of about 7.81 trillion won (US$6.89 billion) a year. The US market for the drug is estimated at 3 trillion won (US$2.65 billion). With the latest approval, Celltrion now has a total of three biosimilars approved by the US FDA, including Remsima, Truxima and Herzuma.

As Celltrion has received approval of its three main strategic products from the US FDA, the company expects to see the sales of its biosimilar products increase in earnest in the US, the largest biosimilar market accounting for more than 50 percent of the total sales around the world.

In February, Celltrion was licensed to sell Herzuma in Europe as well. The company is smoothly expanding its market share as it succeeded in winning the hospital bids that took up nearly 40 percent of trastuzumab sales in France last month.

Teva Pharmaceutical Industries Ltd., which has established marketing networks in the anti-cancer sector, will exclusively commercialize Herzuma in the US. The company is also in charge of sale for Celltrion’s Truxima which gained approval from the US FDA last month, in North America. Truxima is a biosimilar to Roche’s Rituxan (rituximab) treating non-Hodgkin’s lymphoma.

Meanwhile, Celltrion received approval for antibody biosimilar Remsima (infliximab) in the US in April 2016. Remsima currently sells under the brand name of Inflectra through Pfizer Inc. in the US. The company also gained marketing approval for Truxima (rituximab) in the US in November this year. Truxima had a 32 percent market share in Europe as of the second quarter of this year after it was licensed to sell in Europe in February last year.