FDA Chinese Study Concerns Could Derail Drugmakers' Plans

The Food and Drug Administration’s reservations about the quality of studies testing Chinese-developed drugs could change U.S. drugmakers’ plans to bring them to market.

"We have nothing against drugs being developed in China," Richard Pazdur, director of the FDA’s cancer-drugs division told The Wall Street Journal (WSJ) Wednesday. "Our issue is, are those results generalizable to the U.S. population?"

The dilemma threatens to derail the plans of Western drugmakers who were anticipating billions of dollars in sales from Chinese medications. It could also create additional friction between the two countries.

This year, American drugmaker Eli Lilly was planning to launch Tyvyt – a Chinese-developed lung-cancer immunotherapy drug – at a lower price point than similar drugs already on the market.

Pazdur told WSJ he was concerned the Chinese studies use outdated designs, which don’t directly establish whether a Chinese-developed drug works as well as similar U.S.-approved drugs.

He also said he has concerns about the integrity of drug study data in China.

In 2016, Chinese regulators found that about 80% of domestic drug applications used fabricated, flawed or insufficient study data, the British Medical Journal reported.

"The elephant in the room is obviously, what is the quality of the data that is coming from these foreign countries?" Pazdur said.

Some analysts say Chinese biotech companies may need to conduct additional tests of their proposed new drugs in American patients to reassure the FDA of product efficacy.

"There does seem to be a change in tone as to the approvability of these data sets in the U.S.," Jacob Van Naarden, president of Lilly’s oncology unit told WSJ.

According to Pazdur, when a drug is tested only or mainly in one country, such as China, it is difficult to determine if it would provide the same benefit to the U.S. population because there may be differences in medical care and population between countries that affect a drug’s performance.

There are currently about 25 potential cancer treatments that were tested only or mainly in China, Pazdur said.

Lilly executives have said they would sell Tyvyt in the U.S. at a much lower price than older, similar drugs like Merck & Co.’s Keytruda and Bristol-Myers Squibb Co.’s Opdivo, which can cost patients upwards of $150,000 each year.

In a study involving nearly 400 patients with advanced non-small-cell lung cancer, researchers found that patients who received both Tyvyt and chemotherapy extended the average time to disease progression or death to about 8.9 months, versus five months for those only on chemotherapy.

FDA advisers are scheduled to consider the evidence for the drug from Lilly and its Chinese partner Innovent Biologics Inc. on Thursday.

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