“It is likely that the remediation by Celltrion of the issues addressed in the warning letter will result in a delayed approval of the biosimilar products by the FDA,” Teva told investors.
In Teva’s 2017 full-year and fourth-quarter financial results report, the company acknowledged that it is facing a substantial setback after its Republic of Korea-based partner, Celltrion, received a warning letter from the FDA that raised issues related to manufacturing.
“Celltrion is our sole source for [active pharmaceutical ingredient, API] production for fremanezumab and also for Celltrion’s products CT-P10 [biosimilar rituximab] and CT-P6 [biosimilar trastuzumab],” said Teva in its earnings report, adding that “It is likely that the remediation by Celltrion of the issues addressed in the warning letter will result in a delayed approval of the biosimilar products by the FDA.” Teva assured investors that “We are in active dialogue with the FDA in an effort to maintain our priority date for the approval of fremanezumab.”
Fremanezumab is Teva’s monoclonal antibody for the preventive treatment of migraine. The company submitted a Biologics License Application for the product to the FDA in December 2017. Teva had hopes of launching the innovative biologic in 2018.
However, Fierce Pharma reports that Teva’s CEO, Kare Schultz, said that “It could take 6 to 18 months to resolve a warning letter, but we are having [the active pharmaceutical ingredient] API made there and that is not affected by the warning letter, so an approval could be sooner, but we don’t know.” Shultz added that the warning letter addressed problems associated with the finished products portion of the plant, and not the production area.
The letter, recently released in full by the FDA, cites Celltrion’s failure to establish and follow appropriate written procedures that are designed to prevent microbiological contamination of drug products purporting to be sterile, and that include validation of all aseptic and sterilization processes. It also says that Celltrion failed to thoroughly investigate any unexplained discrepancy in its products’ vials, or to investigate visible particles in finished drug products.
The news comes at an already tumultuous time for Israel-based Teva and for Shultz, who is leading the company through a 2-year streamlining process that includes laying off 25% of Teva's workforce and closing manufacturing and research and development sites worldwide.
Teva's stock dropped by 10.6% on Thursday, and by another 4.5% Friday morning.