By Ahmed Aboulenein and Susan Heavey
WASHINGTON (Reuters) -The U.S. Food and Drug Administration on Wednesday said it is aiming to reduce the number of human clinical studies required for approval of certain biosimilar drugs and cut development costs for the medicines made using living cells.
The agency released draft guidance proposing ways to accelerate the availability of less expensive close copies of complex biotech medicines and treat them like generics, enabling doctors to prescribe them more easily.
The move is part of a broader push to cut healthcare costs, U.S. Secretary of Health and Human Services Robert F. Kennedy Jr. said in a press conference.
“Under this new framework, companies may not always need to conduct large, expensive human trials when advanced testing can already prove that biosimilars work just as effectively and just as safely as the original drug,” Kennedy said.
Unlike cheap generic versions of simple-to-manufacture pills, medicines made from living cells cannot be exactly copied, so are referred to as biosimilars.
Major pharmaceutical companies and industry groups have lobbied against such changes that they argue could hurt innovation and limit treatment options.
Kennedy challenged many of the pharmaceutical industry’s arguments for not treating biosimilars as equal to the original branded medicines, saying they were tactics to prevent competition. “The lobby invented a fake distinction between biosimilars and interchangeable biosimilars,” he said.
Biotech drugs are the fastest-growing class of medications in the United States and account for a substantial and growing portion of healthcare costs, the FDA has said.
MULTIPLE BARRIERS
Biosimilars have faced multiple barriers, including physician hesitancy, reimbursement policies, and complex patent litigation.
Drugmakers such as Eli Lilly, Pfizer, Merck and Bristol Myers Squibb have warned investors about the impact of biosimilar competition in regulatory filings, while makers of generic drugs including Teva, Dr Reddy’s and Sandoz have supported reforms.
The FDA’s move follows recent pricing agreements between U.S. President Donald Trump and drugmakers, which have added pressure on branded drug revenues.
Currently, in some circumstances, developers perform “switching studies” to prove their biosimilars should be licensed as interchangeable with the original branded medicine. The FDA said these additional studies can slow development and create public confusion about biosimilar safety.
Once deemed interchangeable, the medicines can be readily substituted for the more expensive drug.
“We’re planting a flag saying we want interchangeability. We promote it, we encourage it,” said FDA Commissioner Marty Makary. The final guidance is expected to come out in three to six months, Makary said.
(Reporting by Ahmed Aboulenein and Susan Heavey; Additional reporting by Siddhi Mahatole in Bengaluru and Deena Beasley in Los Angeles; Editing by Bill Berkrot)
