The U.S. Food and Drug Administration announced Wednesday a significant policy shift aimed at accelerating the approval and availability of biosimilar drugs through streamlined regulatory pathways. The agency released draft guidance proposing to reduce the number of human clinical studies required for certain biosimilar approvals and cut development costs for medicines made using living cells.
Regulatory Framework Changes
U.S. Secretary of Health and Human Services Robert F. Kennedy Jr. outlined the new approach during a press conference, explaining that the framework would allow companies to bypass large, expensive human trials when advanced testing can already demonstrate that biosimilars work as effectively and safely as the original drug.
"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 stated.
The initiative represents part of a broader federal push to reduce healthcare costs by treating biosimilars more like generic medications, enabling doctors to prescribe them more easily. Unlike cheap generic versions of simple-to-manufacture pills, medicines made from living cells cannot be exactly copied, which is why they are referred to as biosimilars rather than generics.
Addressing Market Barriers
Biosimilars have faced multiple barriers to market uptake, including physician hesitancy, reimbursement policies, and complex patent litigation. The FDA's new approach specifically targets the current requirement for "switching studies" in some circumstances, which developers must perform to prove their biosimilars should be licensed as interchangeable with the original branded medicine.
According to the FDA, 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 original drug.
"We're planting a flag saying we want interchangeability. We promote it, we encourage it," said FDA Commissioner Marty Makary, who indicated that final guidance is expected within three to six months.
Industry Response and Market Impact
The proposed changes have drawn mixed reactions from the pharmaceutical industry. Major pharmaceutical companies including Eli Lilly, Pfizer, Merck, and Bristol Myers Squibb have warned investors about the impact of biosimilar competition in regulatory filings and have lobbied against such changes, arguing they could hurt innovation and limit treatment options.
Conversely, generic drug manufacturers including Teva, Dr Reddy's, and Sandoz have supported the reforms. Kennedy challenged the pharmaceutical industry's arguments against treating biosimilars as equal to original branded medicines, characterizing them as tactics to prevent competition.
"The lobby invented a fake distinction between biosimilars and interchangeable biosimilars," Kennedy said during the announcement.
Healthcare Cost Implications
The timing of this regulatory shift follows recent pricing agreements between President Donald Trump and drugmakers, which have added pressure on branded drug revenues. Biotech drugs represent the fastest-growing class of medications in the United States and account for a substantial and growing portion of healthcare costs, according to the FDA.
The Department of Health and Human Services held the public conference to outline these plans as part of the broader initiative to expand access and cut healthcare costs through increased biosimilar availability.
