The product did not earn approval for all indications of the reference Herceptin; it has been approved only for the treatment of HER2-positive gastric cancers, and not for the treatment of HER2-positive breast cancer.
Nippon Kayaku, a Japanese-based drug developer, announced yesterday that it has launched Celltrion’s biosimilar trastuzumab (Herceptin) product in Japan. The biosimilar, CT-P6, was developed by Celltrion and will be sold by Nippon Kayaku, which has also marketed Celltrion’s infliximab biosimilar, Remsima, in Japan.
An application for the marketing approval of the trastuzumab biosimilar, CT-P6, was submitted to Japan’s Ministry of Health, Labor, and Welfare in April 2017. The product did not earn approval for all indications of the reference product, however; it has been approved only for the treatment of HER2-positive gastric cancers, and not for the treatment of HER2-positive breast cancer.
Neither Celltrion nor Nippon Kayaku indicated whether they had sought approval for all indication of the reference Herceptin, though an April 2017 statement by Nippon Kayaku announcing regulatory submission notes that the monoclonal antibody “plays an important role in the treatment of HER2-positive breast cancer,” and in 2015, the company announced the start of a clinical trial of the molecule in patients with breast cancer.
CT-P6 was approved in the European Union in February 2018, and is now sold under the trade name Herzuma. The product is not yet authorized in the United States, however, as Celltrion received a Complete Response Letter (CRL) for the drug in April 2018 from the FDA.
The CRL came after Celltrion had received the FDA’s Form 483 in 2017, noting 12 observations related to a range of issues, including incomplete records, inappropriately designed equipment, deficient environmental monitoring, and inadequate validation of sterilization processes. Then, in February 2018, Celltrion received a warning letter from the agency related to its manufacturing processes. The drug maker has since resubmitted the product to the FDA for approval.