The U.S. Food and Drug Administration (FDA) has seen the rise in biosimilar approvals slow so far this year.
On the 1st (local time), the FDA released the status of biosimilar approvals for the first half of 2026. A total of six biosimilars were approved by the FDA from January to June this year.
That is about one-third of last year's annual approvals (18). The FDA approved 18 biosimilars in both 2024 and 2025, maintaining a record-high pace of approvals.
The approvals in the first half also included first-in-class biosimilars. A representative example is Immolis, referencing Janssen's autoimmune disease treatment "Simponi (golimumab)." It is the first biosimilar approved in the Simponi class.
By nationality of the approving corporations, U.S. corporations led with three, followed by Indian corporations with two and an Israeli corporation with one. However, products in which Chinese corporations such as Sunshine Lake Pharma and Biothera Solutions participated in development were also included.
Since its first biosimilar approval in 2015 through the end of June this year, the FDA has approved a total of 87 products referencing 21 original drugs. Approvals began to increase in earnest after 2019, reaching a record 18 each in 2024 and 2025.
The original products with the most biosimilars approved are "Humira (adalimumab)" and "Prolia/Xgeva (denosumab)," with 10 each. They are followed by "Stelara" and "Neulasta" with eight each, and "Avastin," "Eylea," and "Herceptin," each with six biosimilars.
By nationality in cumulative approvals, the United States leads with 31, followed by Korea with 19. Next are India (12), Germany (8), Switzerland (7), and China (4). Domestic corporations, centered on Samsung Biologics(207940) and Celltrion(068270), are increasing their presence in the U.S. biosimilar market.