The US Food and Drug Administration (FDA) announced the approval of 127 innovator and biosimilar drugs in 2024, a notable decrease from the 149 approvals recorded in 2023. Despite the decline in overall approvals, the year saw a remarkable surge in innovative drug approvals, particularly from small pharmaceutical companies, many of which secured their first market approvals, says GlobalData.
According to GlobalData’s New Drug Approvals and Their Contract Manufacture: 2025 Edition, the 2024 approvals included significant milestones in the biosimilar sector, with the FDA granting approval for the first biosimilar of Stelara, Wezlana, and the first denosumab biosimilars, Wyost and Jubbonti. These advancements are expected to enhance patient access to cost-effective treatments and increase the utilisation of biologics, thereby driving up production volumes.
Kathryn Kinch, Senior Pharma Product Manager, comments, “While the number of biologic new molecular entity (NME) approvals saw a substantial decline, the trend of biologics outpacing small molecule NMEs continued, albeit with a narrowing gap.”
In total, seven cell and gene therapies were approved, including Iovance Biotherapeutics’ Amtagvi T-cell therapy, which is projected to generate $1.2 billion in sales by 2030, marking it as a potential blockbuster in the advanced therapy medicinal products (ATMPs) category.
Additionally, the report highlights contract development manufacturing organisation (CDMO) disruptors or new key players in the industry, such as DNA/RNA specialist Helix Biotech and Minaris Advanced Biotech, which was formed as a result of the acquisitions by Altaris Capital Partners and the US and UK operations of WuXi Advanced Therapies.
The New Drug Approvals and Their Contract Manufacture Report is an annual analysis of approval trends affecting pharmaceutical contract manufacturing organisations. The report lists the latest players, FDA NDA approvals, sponsor trends, special products, outsourced API approvals, ANDA approvals, value chain, and CMO performance.