UPDATED
Celltrion hit with Form 483 over troublesome Incheon plant
Celltrion’s facility in Incheon, South Korea, has had a number of issues already this year and a recent inspection by the US Food and Drug Administration (FDA) has raised eight observations, resulting in a Form 483.
The facility is responsible for producing Celltrion’s two biosimilar prospects to Rituxan (CT-P10) and Herceptin (CT-P6). It has also been contracted by Teva to produce an active pharmaceutical ingredient (API) for its candidate for migraines, fremanezumab.
The findings will be another worry for Teva, which already had its migraine medication approval process potentially delayed due to previous issues at the plant.
In a notice to shareholders, Celltrion stressed that eight observations were “manageable and correctible”, and that it “expects outstanding observations will be lifted very soon”.
The FDA’s inspection report highlighted the lack of written procedures for production and process controls; in particular, the Agency noted: “Your firm lacks adequate documentation to ensure vials that may have been compromised with glass particles did not proceed to the filling step.”
Also noted were issues in regard to the training of staff, specifically only using photographs for training to prevent glass particles in vials, and failure to document the time and temperature of samples during transfer between freezers.
Celltrion has responded to the observations with a “comprehensive response”, provided to the Agency “ahead of schedule”.
A spokesperson for Celltrion responded to a request for comment stating that the company "awaits the outcome of the recent re-inspection and expects outstanding observations will be lifted very soon."
In relation to when the reinspection was expected, the spokesperson revealed it had already taken place from July 9 to July 17, 2018.
Teva’s migraine med headache
Teva has had a difficult few years, which led CEO Kåre Schultz to embark on a company-wide restructure – leading to plans to close a number of manufacturing facilities globally.
One of the drugs it is looking to in order to bolster its revenue is fremanezumab, an anti-calcitonin gene-related peptide (CGRP) monoclonal antibody, a treatment for migraines.
Its rival in the area, Novartis, recently achieved European approval for its own CGRP mAb and Teva will be hoping that this latest hiccup at Celltrion’s facility does not result in another delay.
In response to a question concerning the likelihood of this being the case, a spokesperson from Teva told us: "Teva has reviewed the observations and do not feel they will impact our approaching PDUFA [Prescription Drug User Fee Act] date for fremanezumab."
