The Trump administration hopes to increase the number of biologic medications available to Americans by speeding up FDA approval for competitors. That alone won’t drive down the high cost of these medications, experts said.
Biologics are complex medications produced through biological processes or from living organisms such as proteins and genes. Biosimilars are what they sound like — similar to, but not the same as, an original U.
S. Food and Drug Administration-approved biologic. Streamlining biosimilars’ approval processes might help increase their availability, but that won’t immediately reduce their prices, experts said. If you watch TV and don’t mute ads, you’ve probably heard of a few biologics. They’re drugs such as Humira for arthritis and Trulicity for Type 2 diabetes. You may also know they are expensive. Biologics represented 5% of the drugs prescribed in the U.S. in 2024, but they accounted for more than half of the country’s total prescription medicine spending, according to health data analysis company IQVIA.to make these medications more affordable partly by increasing access to"biosimilars," or highly similar products. What are biologics and biosimilars and will the administration’s proposals help drive down their costs?vaccines, blood and blood components, gene therapy and tissues. They are a class of complex drugs produced through biological processes or from living organisms such as proteins and genes. They treat cancer, autoimmune diseases and other rare disorders. Biologics are typically administered by injection or through an intravenous infusion, said Alex Keeton, executive director of the Association for Accessible Medicines’ Biosimilars Council, an industry group that advocates on behalf of biosimilar manufacturers. The FDA approval process for these products is rigorous and typically takes 10 to 15 years, said Brian Chen, a University of South Carolina health law and economics expert. Speedier timelines are possible in extraordinary circumstances: Federal agencies worked with vaccine manufacturers and scientists toAs the name suggests, these medications are similar to the original biologics approved by the FDA. Biosimilars are developed and"They still work the same way, clinically, but they’re not exactly the same," Keeton said. That’s because, unlike with generic versions of brand name drugs, it’s impossible to make exact copies of biologics. Biologics have complicated production processes and their "Biologics are like strands of flexible, cooked spaghetti folded in very specific ways, making exact replication nearly impossible," Chen said.proposed biosimilar products against the original biologic to determine that the product is extremely similar and has no meaningful clinical differences. It is expected to have the same benefits and risks as the original biologic., biosimilar manufacturers show that patients using their products don’t have new or worsening side effects compared with patients using the original biologic.Making a standard These complex manufacturing procedures and proprietary information make it difficult for competitors to create alternatives.and show that their products are highly similar and have no clinically meaningful differences from its existing FDA-approved biologic counterpart., the administration proposed reducing some of the tests required as part of the FDA process used to prove a biosimilar drug is as safe and effective as its biologic counterpart. Previously, a manufacturer requesting a biosimilar license had to provide clinical study data proving its product’s similarity. The FDA’s newManufacturers would still be required to test proposed biosimilars. Other data — including comparative analysis, immune response data and human study data showing how the drug moves through the body — could sufficiently demonstrate the drug’s similarity to an existing biologic, the FDA said.Ultimately, the agency said it aimed to incentivize drug manufacturers to quickly develop biosimilars by eliminating redundant, costly and time-consuming clinical studies, Keeton said.It will almost certainly lower the front-end development costs for drug makers, Chen said.Several non-brand name options need to be available in order to produce significant price drops, according to a Department of Health and Human Servicesfound that annual out-of-pocket costs either increased or remained stable for most biologics even after biosimilars were available. Patients who used biosimilars didn’t pay less than those who used the original biologics. That’s at least partly because biologic manufacturers often offer substantial rebates to pharmacy benefit managers, companies that work with insurers, employers and others toprescription drug plan benefits. In exchange, insurers give the name brand biologics preferred or exclusive placement on their lists of insurance-covered drugs, Chen said. Rebate walls ultimately prevent the sale of cheaper biosimilars, he said.found that of 12 FDA-approved biosimilar products as of October 2018, five were commercially available. Six others were unavailable because of patent disputes. Interview with Alex Keeton, executive director of the Association for Accessible Medicines’ Biosimilars Council, Nov. 10, 2025 Email interview with Brian Chen, associate professor of health services policy and management at the University of South Carolina’s Arnold School of Public Health, Nov. 9, 2025 Why Biologics and Biosimilars Remain So Expensive: Despite Two Wins for Biosimilars, the Supreme Court’s Recent Rulings do not Solve Fundamental Barriers to Competition A Critical Analysis of the FDA Draft Guidance on Development of Therapeutic Protein Biosimilars: Comparative Analytical Assessment and Other Quality-Related Considerations There was not “a single, prominent conservative voice in the country that even remotely wanted or hoped or was pushing to get Jimmy Kimmel taken off the air.” Un vídeo muestra al presidente francés, Emmanuel Macron, al primer ministro del Reino Unido, Keir Starmer, y al canciller alemán, Friedrich Merz, con una bolsa de cocaína tras visitar al presidente ucraniano, Volodymyr Zelenskyy. A video shows French President Emmanuel Macron, United Kingdom Prime Minister Keir Starmer and German Chancellor Freidrich Merz with a bag of cocaine after visiting Ukrainian President Volodymyr Zelenskyy.Video shows Canadian Prime Minister Mark Carney saying effective June 1, “all vehicles manufactured before 2000 will be gradually phased off Canadian roads due to safety and emissions standards.”
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