US FDA to Streamline Biosimilar Approval Process

Simplifying Biosimilarity Studies
Streamlining Unnecessary Clinical Trials

The U.S. Food and Drug Administration (FDA) announced on October 29 (local time) that it will significantly streamline the approval process for biosimilars (biologic drug copies).

Food and Drug Administration (FDA) headquarters in White Oak, Maryland, USA Photo by Reuters Yonhap News

The FDA stated, "In the new draft guidance, the FDA has proposed major revisions to simplify studies proving biosimilarity and to reduce unnecessary clinical trials."

The agency further explained, "Through a separate initiative, we also plan to simplify procedures so that biosimilars can be developed as interchangeable forms with original drugs," adding, "This will help patients and pharmacists more easily choose lower-cost alternative medicines."

The FDA noted that although high-priced biologics account for only 5% of all prescriptions in the United States, they represent 51% of total drug spending as of 2024.

In contrast, despite biosimilars approved by the FDA having the same level of safety and efficacy as original drugs, their market share remains below 20%.

According to the Financial Times (FT), last year, the European Medicines Agency (EMA) approved 110 biosimilars, while the FDA approved only 42. FT analyzed that, in line with the drug price reduction policies promoted by the Donald Trump administration, this measure could affect the profitability of global pharmaceutical giants such as Eli Lilly, Pfizer, Merck, and Bristol Myers Squibb.

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