The US Food and Drug Administration (FDA) approved 127 innovator and biosimilar drugs in 2024, marking a decline from the 149 approvals recorded in 2023, according to a report by leading data and analytics firm GlobalData.

Despite the overall drop, 2024 witnessed a significant surge in innovative drug approvals from small pharmaceutical companies, many of which secured their first market approvals.

GlobalData’s New Drug Approvals and Their Contract Manufacture 2025 report highlighted several landmark approvals in the biosimilar segment. Notably, the FDA approved the first biosimilar to Stelara—Amgen’s Wezlana—along with the first denosumab biosimilars, Wyost and Jubbonti, developed by Sandoz.

Wezlana, like its reference product Stelara, is indicated for multiple inflammatory diseases including plaque psoriasis, psoriatic arthritis, Crohn’s disease, and ulcerative colitis.

Wyost (denosumab-bbdz) is approved as an interchangeable biosimilar to Xgeva (denosumab) for patients with bone metastases from solid tumors and multiple myeloma.

Jubbonti (denosumab-bbdz) injection was approved as an interchangeable biosimilar to Prolia (denosumab) and is indicated for patients with osteoporosis, bone loss due to steroid use, or those undergoing hormone therapy for breast or prostate cancer.  

Commenting on the trends, Kathryn Kinch, Senior Pharma Product Manager at GlobalData, said,” “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.”

The report also noted the approval of seven cell and gene therapies, including Iovance Biotherapeutics’ Amtagvi T-cell therapy, which is projected to generate USD 1.2 billion in sales by 2030, potentially becoming a blockbuster in the advanced therapy medicinal products (ATMPs) category.

Amtagvi is a prescription medicine used to treat adults with unresectable or metastatic melanoma— a type of skin cancer that cannot be removed surgically or has spread to other parts of the body.

Additionally, the report underscored the emergence of new players in the contract development and manufacturing organisation (CDMO) space, such as DNA/RNA specialist Helix Biotech and Minaris Advanced Biotech—established following the acquisition of WuXi Advanced Therapies’ US and UK operations by Altaris Capital Partners LLC.