Why is it difficult for Korean pharma to get FIC designation in US? < Pharma < Article

For Korean pharmaceutical companies to receive the first-in-class (FIC) designation in the United States, they should focus more on rare disease treatments, a state agency said.

The Korea Health Industry Development Institute (KHIDI) said so in a report, “Factors influencing innovate new drug development,” released Monday.

“We could indirectly confirm that it was not easy for Korean pharmaceutical companies to develop new FIC drugs,” the authors said. “First, according to classification by the U.S. Food and Drug Administration, most Korean drugmakers were categorized as small- and medium-sized (SME) pharma companies, non-U.S. drugmakers, SMEs as original developers, and no development company changes, showing gaps in approval rates.”

According to the report, U.S. companies lead in developing innovative new drugs. The U.S. firms accounted for 68.1 percent of companies designated as FIC by the FDA, 14.1 percent higher than 54 percent, the comparable share of U.S. pharma companies in non-FIC new drugs.

Especially when the developers were smaller drugmakers, the designation rate of non-U.S. companies was lower than their U.S. counterparts by as much as 20.6 percent, it said.

Also, the FIC rates of smaller new molecular entities (NMEs) by U.S. and non-U.S. SMEs with development company changes showed no significant differences, at 30.4 percent and 40 percent. However, the comparable gap in the NME FIC rate was more than double, at 51.2 percent vs. 25 percent, when there were no development company changes, such as the cases of most Korean companies that developed independently and received approval.

Aside from these differences between the U.S. and foreign companies, the report pointed out that Korean pharma companies lack rare disease treatment pipelines, the core factor in designating innovative new drugs.

“The rare disease treatment market has high risk, making it difficult for Korean companies to develop them. However, the market is growing continuously, and the U.S. government prefer their developers as shown by its various supports, making a potentially good market for Korean drugmakers targeting global markets,” it said. “The Korean government also needs to provide policy and other supports for drugmakers to develop rare disease treatments in their global clinical trials and technology exports.”

The report noted that it is challenging to receive innovative designation if they develop anticancer drugs similar to existing ones because the FDA prioritizes their novelty. Still, 38.1 percent of about 1,900 new drug pipelines of Korean companies, or 38.1 percent of the total, were anticancer drugs in 2022.

“Because of their large market scale, anticancer drugs’ development could have positive commercial effects,” it said. “However, in evaluating new drugs’ innovativeness, it is important to have relative superiority over existing drugs or drugs developed by other companies. So, Korean companies should consider investing in developing other drugs.”

Meanwhile, the study analyzed data on 482 new drugs designated as FIC by the FDA from 2010 to 2021 by regulations, substances, effects, corporations, and original developers.

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