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.