Celltrion¡¯s Remsima faced 12 problems in FDA manufacturing process
Kim Ji Seob | cloud50@ | 2017-09-08 11:06:38


Celltrion has been identified in June as having pointed out 12 problems in the due diligence stage of the US Food and Drug Administration`s (FDA) Remsima production.

According to the US RAPS on September 7, Celltrion received `FDA 483` as it failed to meet some excellent pharmaceutical manufacturing and quality control standards (GMP) at the Incheon Yeonpu District Manufacturing Process Survey from May to June . `Remsima` (US product name Infractra) is an autoimmune disease drug developed and produced by Celltrion. It is a biosimilar that replicates Johnson & Johnson`s Remicade.

FDA 483 is the document that the FDA points to after the due diligence. Celltrion is reported to have made some improvements in 2015 in response to related notifications. According to the document, Celltrion confirmed a "mismatch". This is due to a problem with the existing vacuum condition, such as air leaks from some vials (vials). In addition, foreign substances were detected in some of the manufactured Ram Shima. In addition, the FDA pointed out that some sterilization processes were not properly performed and that defects were found in systems that monitor aseptic processing space. Also, some inappropriate designs were found at the manufacturing facility, he added.

Celltrion representative said, "The issue has already been corrected, and the issue raised was not a quality issue, such as Remsima`s equality and safety. Some of the detected foreign substances were found in the test phase just before the final shipment of the first half of this year and the investigation was carried out at Celltrion and European local institutes," he said. "The matter was recovered before shipment and the investigation was completed well."

Meanwhile, Celltrion reported these improvements to the FDA on August 31, and the FDA is currently reviewing them.

On the other hand, some issues have raised concerns that Remsima`s manufacturing facilities are having a problem because of the 12 issues they have raised. An industry expert said, "The fact that the FDA is in the spotlight may lead to measures to limit sales.¡±


By Kim Ji Seob cloud50@


[ copyright ¨Ï The Digitaltimes ]