FDA Raises Concerns About China-Developed Drugs

A negative FDA staff report for Eli Lilly and partner Innovent Biologics' anti-PD-1 cancer drug sintilimab could slow the plans of large Western drugmakers such as Novartis looking to sell Chinese-tested medicines in the US, reported The Wall Street Journal.

Eli Lilly this year was aiming to roll out the lung-cancer immunotherapy developed in China and sell it at a lower price than similar drugs already on the market. The impact of the FDA staff concerns could become clearer on February 10, when agency advisers consider the evidence for the drug.

"We have nothing against drugs being developed in China," said Richard Pazdur, director of the FDA's cancer-drugs division. "Our issue is, are those results generalizable to the US population?"

In 2019, the FDA approved BeiGene's lymphoma drug Brukinsa that had been primarily tested in China. Most subjects in the clinical studies that led to the approval were in China, but some were in the US.

That same year, Pazdur said at a medical conference that the FDA would accept Chinese-only drug-study results if they were "quality" data. Industry executives and analysts viewed his comments as offering a kind of shortcut for China-tested drugs to get cleared in the US without having to do extensive US trials.

"Now that path appears to be closing," remarked Bernstein analyst Ronny Gal, saying Pazdur's more recent comments amounted to "a clear change in tone at the FDA, from encouraging this to discouraging this."