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US FDA plans to accelerate biosimilar approvals, FT reports
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US FDA plans to accelerate biosimilar approvals, FT reports
Oct 29, 2025 6:41 AM

Oct 29 (Reuters) - The U.S. Food and Drug Administration

is preparing to speed up approvals for biosimilars, or generic

versions of complex biological drugs, the Financial Times

reported on Wednesday.

The regulator is expected to reduce the number of human

clinical studies required for certain biosimilars and cut

development costs for medicines made using living cells, the

report said.

The move comes despite lobbying efforts from major

pharmaceutical companies and industry groups, which have argued

that easing requirements could hurt innovation and limit

treatment options, according to the FT report.

Biological drugs are the fastest-growing class of

medications in the United States and account for a substantial

and growing portion of health care costs, the FDA has said.

Biosimilars have faced multiple barriers to uptake,

including physician hesitancy, payer policies, and complex

patent litigation, FT noted.

Drugmakers such as Eli Lilly ( LLY ), Pfizer ( PFE ),

Merck ( MRK ) and Bristol Myers Squibb ( BMY ) have warned

investors about the impact of biosimilar competition in

regulatory filings, while generics makers including Teva

, Dr Reddy's and Sandoz have

supported reforms, the report added.

The FDA's reported move follows recent pricing agreements

between U.S. President Donald Trump and drugmakers, which have

added pressure on branded drug revenues.

The Department of Health and Human Services did not

immediately respond to Reuters request for comment.

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