[Notice to shareholders] Celltrion receives EIR from the FDA
Celltrion confirms that in July 2018, the U.S. Food and Drug Administration (FDA) completed its re-inspection on the warning letter at Incheon, Republic of Korea.
Celltrion received an Establishment Inspection Report (EIR) from the FDA on September 17, 2018 (issued on September 13, 2018) which details the inspection completed in July. In the EIR, the FDA classified the facility as Voluntary Action Indicated (VAI).
Also, the FDA has scheduled an Oncology Drug Advisory Committee (ODAC) for October 10, 2018 on CT-P10, CELLTRION’s proposed monoclonal Antibody (mAb) biosimilar to Rituxan®(rituximab). The ODAC will evaluate the data and make appropriate recommendations on the approvability of CT-P10.
Celltrion is committed to working with the Agency to gain approval of CT-P10 and CT-P6 by the end of this year.