In the first half of this year, the number of new drugs approved by the U.S. Food and Drug Administration (FDA) was 16, the lowest number since 2016. It appears that global large pharmaceutical companies (big pharma) have focused on expanding prescriptions for existing drugs in recent years, resulting in a decrease in the number of new drugs seeking FDA approval, along with factors such as workforce reductions and shifts in review policies at the FDA.
Eugene Securities noted in a report on 'new drugs approved by the FDA in the first half of 2025' on the 3rd that the number of new drugs approved by the FDA this year has decreased 25% compared to the same period last year, and when compared to the average of the last five years (23), it represents a sharp decline.
The new drugs approved by the FDA in the first half of this year were primarily products from big pharma companies such as Britain's AstraZeneca, the U.S. Johnson & Johnson (J&J), the U.S. AbbVie, Switzerland's Novartis, and France's Sanofi.
In particular, two antibody-drug conjugate (ADC) anticancer new drugs, known as 'guided missiles that only target cancer cells,' received approval one after another. ADC is a treatment technology that attaches a drug to an antibody that binds to cancer cells, delivering the drug directly to the cancer cells. In January and May, AstraZeneca's breast cancer treatment and AbbVie's lung cancer treatment respectively received FDA approval.
Vertex Pharmaceuticals' oral non-narcotic pain reliever, Jenabax, was also approved as a pain treatment at the end of January. While it attracted attention as a non-narcotic pain reliever that appeared for the first time in 25 years, analysis indicated that its high price and early stage of release would make market entry take longer.
Kwon Hae-soon, the chief research officer at Eugene Securities, analyzed the decrease in new drug approvals by the FDA, stating, 'In the last five years, approvals and launches of new drugs developed by big pharma have continued, and currently big pharma is focusing on expanding indications and adding labels, so the launch of new drugs is relatively decreasing.'
The development of innovative new drugs with principles different from existing treatments is not easy, and the FDA's scrutiny of new treatment methods has become more stringent. Big pharma has instead concentrated on expanding the treatment targets (indications) of drugs already on the market.
There are also opinions that the recent large-scale restructuring at the FDA may have affected this situation. U.S. Health and Human Services Secretary Kennedy Jr. has been carrying out a campaign to reduce federal personnel, with 3,500 FDA employees being cut. Oh Gi-hwan, executive director of the Korea Bio Association, said, 'Concerns about delays in approvals due to workforce reductions at the FDA are growing,' noting that there were cases where approvals scheduled for the first half of the year were postponed.
The FDA is currently working to replace and supplement the reduced workforce with an artificial intelligence (AI) system. In fact, the generative AI 'Elsa' has been operational since last month, assisting in summarizing adverse event reports to support safety profile construction.
Kwon Hae-soon, the chief research officer, stated, 'Whether the decrease in FDA new drug approval numbers is a temporary phenomenon or a structural change remains to be seen,' adding that 'the investment appeal for companies possessing innovative technologies remains strong, and attention should be paid to companies related to new drugs expected to be approved in the third quarter.'
Among the new drugs expected to be approved by the FDA in the second half of the year is a Kitruda SC immune anticancer drug developed by MSD, applying the technology of the domestic bio company Alteogen. This drug modifies MSD's blockbuster anticancer drug Kitruda from an intravenous (IV) administration method to a subcutaneous (SC) injection.
While intravenous injections take 4 to 5 hours, subcutaneous injections can be done in under 5 minutes and allow patients to administer the treatment themselves at home. By changing the formulation in this way, the drug can receive approval as a new drug, potentially extending the patents of blockbuster pharmaceuticals.