FDA tells Celltrion a consultant may be in order for its troubled biologics plant

Celltrion plant
The FDA has suggested that Celltrion hire a consultant to help with improvements to its biologics manufacturing processes at a plant in South Korea that has been issued a warning letter. (Celltrion)

The impact of an FDA warning letter issued last month for a Celltrion plant in South Korea has broadened to Teva Pharmaceuticals, which reported last week it delayed approval of its promising migraine drug, as well as two biosimilars for which it recently forked over $160 million to Celltrion to gain the rights.

That disclosure came even as the FDA publicly posted the warning letter last week in which it recommends the South Korean company consider hiring outside experts to help it get its production in order.

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Teva CEO Kåre Schultz pointed out in a call with analysts that the warning letter was for issues the FDA has with the finished products portion of the plant, the areas where fill-finish is done, and not the production area where the API is manufactured for its anticipated migraine drug fremanezumab.

RELATED: Teva faces unexpected delay for its migraine drug candidate even as generics pressures worsen

The plant also makes the APIs for the biosimilar candidates for Rituxan and Herceptin, which Celltrion has agreed to share with Teva in the U.S. through a licensing deal for which Teva agreed to pay up to $160 million. The CEO said Teva is in talks with the FDA about how that might affect its drug candidates, but the company acknowledged it could delay approvals at a time when Teva is desperately in need of more revenue.

“It could take six to 18 months to resolve a warning letter, but we are having API made there and that is not affected by the warning letter, so an approval could be sooner, but we don’t know,” Shultz said on the call with analysts.

The plant also makes Inflectra, the Remicade biosimilar shared by Celltrion and Pfizer, but the companies have said they don’t expect any supply interruption as a result of the warning letter. Celltrion has said it is working closely with the FDA to quickly resolve concerns. However, the warning letter is serious enough that agency recommended the South Korean biologics producer consider hiring a consultant.

“In particular, the consultant should comprehensively assess your investigation and trending systems, aseptic processing line hazards, the media fill program, and the quality of batches produced for the United States,” the FDA warning letter says. The agency, however, reminded the company that even if it does get outside help, Celltrion’s “executive management remains responsible for fully resolving all deficiencies and for ensuring ongoing CGMP compliance.”

When Celltrion received an FDA Form 483 last fall for the plant where it produces biosimilars with Pfizer, the South Korean company shrugged it off by saying it was routine. But what Celltrion thought was a routine citation was elevated by the FDA to a warning letter, issued last month.

The letter criticizes the facility for having poor practices in the aseptic fill area and ordered the company to do a retrospective assessment of all media fills for the last four years. It also pointed out issues about the plant’s investigation of visible particles in finished drug products that were bound for the U.S., among other issues.

As for Teva, it expects to have more control over its biologics manufacturing in the future at a plant it is building at its site in Ulm, Germany. The drugmaker indicated last week that it is investing about $200 million this year in the new biologics plant. The project, which is slated to be complete in 2020, is being built even as the drugmaker is whacking up to 25 other manufacturing plants in the next two years as part of Schultz’s $3 billion cost-cutting effort that will also eliminate 14,000 jobs.

“We are spending a sizable amount to build a biologics plant in Germany, because one of the key strategic moves that we're making for the coming years is to have our own large-scale biologics manufacturing,” Teva CFO Michael McClellan explained on last week’s earnings call.