Celltrion announced that the FDA has issued Complete Response Letters (CRLs) for two of its products, CT-P10, a proposed rituximab biosimilar referencing Rituxan, and CT-P6, a proposed trastuzumab biosimilar referencing Herceptin.
The U.S. Food and Drug Administration (FDA) sends a complete response letter to communicate it has completed its review of a new or generic drug application, and it decided that it will not approve it for marketing in its present form.
According to a statement on Celltrion’s website, the FDA has requested supplementary information about the products. Celltrion says that it will work closely with regulators to address the issues that led to the CRLs, and that it expects to receive FDA approval of both drugs within the year.
US regulatory issuing CRLs does not come entirely as a surprise – the Republic of Korea drug maker received the FDA’s Form 483 last year, noting 12 observations related to a range of issues, including incomplete records, inappropriately designed equipment, deficient environmental monitoring, and inadequate validation of sterilization processes.
In February 2018, Celltrion received a warning letter from the agency related to its manufacturing processes. Celltrion’s partner Teva Pharmaceutical Industries said that remediation of the manufacturing facility’s issues would likely result in a delayed approval of the drugs. Teva said set up a joint venture with South Korea’s Celltrion Healthcare in October 2016.
Despite these manufacturing issues at the Celltrion facility, CT-P6 recently gained an EU marketing authorization and Celltrion plans to launch the product in Europe under the name Herzuma. CT-P10 is also approved in the European Union, where the treatment is marketed under the brand names Blitzima, Ritemvia, Rituzena, and Truxima.
EDIT: Our editorial team was contacted by Celltrion with the clarification that FDA did not reject the drug, but delayed the approval of it, requesting additional information about the product. In light of this, we have changed the title of the article.