US FDA to streamline biosimilar approvals, FT reports ReutersOctober 29, 2025 at 5:57 AM 0 FILE PHOTO: Signage is seen outside of the Food and Drug Administration (FDA) headquarters in White Oak, Maryland, U.S., August 29, 2020. REUTERS/Andrew Kelly/File Photo (Reuters) The U.S.
- - US FDA to streamline biosimilar approvals, FT reports
ReutersOctober 29, 2025 at 5:57 AM
0
FILE PHOTO: Signage is seen outside of the Food and Drug Administration (FDA) headquarters in White Oak, Maryland, U.S., August 29, 2020. REUTERS/Andrew Kelly/File Photo
(Reuters) -The U.S. Food and Drug Administration is preparing to accelerate 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.
The FDA's 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.
(Reporting by Siddhi Mahatole in Bengaluru; Editing by Shailesh Kuber)
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