(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, Pfizer, Merck and Bristol Myers Squibb 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.
(Reporting by Siddhi Mahatole in Bengaluru; Editing by Shailesh Kuber)
Brought to you by www.srnnews.com
