One of the most persistent challenges in U.S. healthcare is the high cost of prescription drugs. Biologic medications, which treat many chronic and serious diseases, often come with steep price tags. Recently, the Food and Drug Administration (FDA) announced plans to accelerate the approval process for generic versions of these complex biologics, known as biosimilars. This effort aims to make these important therapies more accessible by reducing development time and regulatory burdens.
Biologics differ significantly from traditional chemically synthesized drugs because they are produced using living cells. This complexity translates into a longer, more costly development and approval cycle. They currently account for just 5% of all prescriptions in the U.S., yet represent 51% of total drug spending as of 2024. Biosimilars, or essentially generic alternatives to biologics, hold the promise of making these vital medicines more affordable, but their market penetration remains limited.
FDA Commissioner Dr. Marty Makary explained that the agency’s new reforms aim to cut the usual five to eight years required for biosimilar development roughly in half. One of the major changes includes significantly reducing the clinical testing requirements. Traditionally, manufacturers had to conduct extensive human trials comparing the biosimilar to its branded counterpart to prove safety and efficacy. The FDA now proposes that analytical testing alone may suffice in many cases to demonstrate similarity. This shift could save companies tens of millions of dollars and speed products to market.
The Health and Human Services Secretary, Robert F Kennedy Jr., underscored that the existing approval system was outdated and held back competition. “That all ends today,” he said, praising the agency’s efforts to remove barriers that once slowed biosimilar access.
Currently, the U.S. has approved 76 biosimilars, a small fraction compared to the overall number of biologics. While biosimilars have been shown to be as safe and effective as brand-name drugs, challenges remain beyond initial approval. For instance, in the U.S., pharmacists often cannot substitute a biosimilar for its branded drug without physician approval, unless the biosimilar has received an additional “interchangeable” designation. The FDA also plans to ease the path toward this interchangeable status, which can further expand biosimilar use and drive price competition.
Industry groups like the Association for Accessible Medicines welcomed the announcement, emphasizing that accelerated approvals and regulatory reliefs will help get lower-cost biosimilars to patients sooner. Biosimilars typically cost around half as much as their branded counterparts, and their introduction can bring additional price reductions for the original products, sometimes by as much as 25%.
The cost savings are significant. In 2024 alone, biosimilars saved the U.S. healthcare system an estimated $20 billion. For patients, this means more affordable access to treatments for conditions such as cancer, autoimmune disorders, and rare diseases. The ability to bring biosimilars to market faster could benefit millions who struggle with costly medications.
This reform is part of broader Trump administration initiatives aimed at controlling prescription drug prices in the U.S. Other policies include an executive order requiring drug companies to offer their products at the lowest prices comparable globally and a soon-to-be-launched online platform for transparent drug pricing.
While these FDA proposals mark a notable shift, final rules are pending, and some changes require congressional approval to be fully enforceable. Nonetheless, the agency remains committed to moving forward to reduce regulatory hurdles. As Dr. Makary stated, the agency advocates that all biosimilars should achieve interchangeability and become viable, affordable options for patients without delay.
Recent regulatory reforms have introduced new momentum to the effort of lowering drug costs by enhancing competition. By cutting the red tape around biosimilar development and approval, the U.S. may see accelerated entry of these generic biologics into the market, ultimately benefiting consumers and the healthcare system alike
