The agency’s reservations could disrupt the plans of Western drugmakers, including Eli Lilly and Novartis, which planned to sell China-developed drugs in the U.S. in 2022.
Eil Lilly and its Chinese partner, Innovent Biologics, planned to roll out a China-developed lung-cancer immunotherapy called Tyvyt and sell it at a lower price than similar drugs on the U.S. market.
The FDA’s advisory committee is set to vote Feb. 10 on whether the agency should approve the drug. U.S. regulators have expressed concern as to whether Chinese clinical-trial results are applicable to U.S. patients.
“We have nothing against drugs being developed in China,” said Richard Pazdur, MD, director of the FDA’s Oncology Center of Excellence. “Our issue is, are those results generalizable to the U.S. population?” he told the Journal, adding that it is difficult to determine whether a drug would have the same benefits and safety profile in the U.S. when it is tested primarily in a single country.
Drug industry analysts said the FDA’s reservations may mean Chinese biotech companies and their Western partners will need to lead additional U.S.-based tests for their proposed drugs.
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