Celltrion announced last week that it has submitted an application for approval of Herzuma, its proposed trastuzumab biosimilar (CT-P6), in Japan.  Trastuzumab is a monoclonal antibody indicated for the treatment of patients with metastactic breast cancer whose tumors overexpress the HER2 protein and who have received one or more chemotherapy regimens.  Celltrion’s Herzuma (trastuzumab) is a biosimilar to Roche/Genentech’s Herceptin®.   According to the announcement, the application was submitted on April 11, 2017, and once approved, Herzuma will be marketed and distributed in Japan by Nippon Kayaku, pursuant to an agreement with Celltrion.  Celltrion’s Remsima, an infliximab biosimilar, is already approved in Japan.

Celltrion’s Truxima (rituximab) was approved in Europe on February 22, 2017, as we reported here, and the Company also announced last week that it has now officially launched the product in Europe, making actual sales in the UK.  Rituximab is an anti-CD20 monoclonal antibody approved for the treatment of non-Hodgkin’s lymphoma, chronic lyphocytic leukemia, rheumatoid arthritis, granulomatosis with polyangitis, and microscopic polyangitis. Truxima, a biosimilar to Biogen and Roche/Genentech’s Rituxan®, was the first biosimilar product for the treatment of cancer approved in Europe.  Truxima was also approved in South Korea in November 2016.

The company has stated that it plans to submit applications for Herzuma and Truxima to the FDA during the first half of 2017.