President Trump’s FDA overhaul could slash biosimilar drug costs by up to 70% as outdated regulatory hurdles are finally being eliminated through executive action.
Key Takeaways
- FDA’s current biosimilar approval process requires excessive clinical trials costing $100-300 million per drug, driving up healthcare costs unnecessarily
- Biosimilars have already saved Americans $36 billion and provided over 495 million days of patient therapy since 2015
- Trump’s recent executive orders specifically target accelerating biosimilar approvals and reducing anti-competitive practices by pharmaceutical manufacturers
- Only 10% of 118 biologic patent expiries over the next decade currently have biosimilar competition in development due to regulatory barriers
- Modern analytical methods can confirm biosimilar safety and efficacy without redundant clinical studies that delay affordable medications
Trump’s Executive Action on Drug Pricing
President Trump signed two executive orders in 2025 that directly address the growing crisis of prescription drug costs in America. The April 15 order titled “Lowering Drug Prices by Once Again Putting Americans First” tackles 12 specific areas related to drug pricing, while the May 12 order “Delivering Most-Favored Nation Prescription Drug Pricing to American Patients” focuses on drug importation and eliminating anti-competitive tools used by pharmaceutical companies. Both orders include specific provisions for accelerating the approval of biosimilars – less expensive alternatives to costly biologic medications used to treat cancer, rheumatoid arthritis, and other serious conditions.
The executive orders specifically direct the FDA to issue reports and recommendations to speed drug approvals and reduce anti-competitive behavior that keeps prices artificially high. One key section states: “Sec. 10. Increasing Prescription Drug Importation to Lower Prices. Within 90 days of the date of this order, the Secretary, through the Commissioner of Food and Drugs, shall take steps to streamline and improve the Importation Program under section 804 of the Federal Food, Drug, and Cosmetic Act to make it easier for States to obtain approval without sacrificing safety or quality,” said President Trump in his executive order.
Are you tired of paying too much for medications?
I just introduced a bill to make your prescription drugs more affordable: The Biosimilar Red Tape Elimination Act.
“Biosimilars” – generic alternatives to name-brand medications – have the potential to significantly reduce the…
— Mike Lee (@SenMikeLee) June 9, 2025
The Biosimilar Development Crisis
Since the FDA approved the first biosimilar in 2015, these alternatives to costly biologics have saved Americans approximately $36 billion and provided over 495 million days of patient therapy. However, the current development and regulatory process remains outdated and doesn’t align with scientific advancements, causing unnecessary costs and delays. These regulatory hurdles have created what experts call a “biosimilar void” – a situation where patients are denied access to affordable treatments due to bureaucratic red tape rather than legitimate safety concerns.
“Biosimilar streamlining isn’t just a bureaucratic fix or a regulatory refinement, it is a critical solution to address the ‘biosimilar void,’ bringing high-quality, affordable medicines to market more quickly and giving patients better, faster access to the treatments they need,” states the Biosimilars Council.
The problem is particularly alarming when looking at future market competition. Out of 118 biologic patent expiries expected over the next decade, only 10% have biosimilar competition in development. This lack of competition allows original reference biologics to maintain monopoly pricing, with patients and the healthcare system bearing the financial burden. The Biosimilars Council suggests eliminating outdated regulatory requirements, such as comparative clinical efficacy studies, which account for half of the total development cost of a biosimilar – ranging from $100-300 million per drug.
Modern Science vs. Outdated Regulation
Modern analytical methods now allow for much quicker and more accurate confirmation of biosimilar safety and efficacy than was possible when the regulatory framework was first established. These advanced scientific tools enable smarter, more targeted testing that ensures biosimilars are both safe and effective without requiring the extensive, redundant studies currently mandated. The FDA’s insistence on these outdated testing protocols directly contributes to higher healthcare costs and reduced access to life-saving medications for millions of Americans.
“Imagine a world where cutting-edge medicines developed to treat complex conditions like cancer and autoimmune diseases reach patients faster and at a lower cost,” states the Biosimilars Council.
Senators Mike Lee and Rand Paul have been vocal advocates for reforming these regulations, pointing to the European Medicines Agency’s more risk-based approach that has successfully brought biosimilars to market faster without compromising safety. The European model dispenses with unnecessary trial requirements when safety and biosimilarity can be demonstrated through alternative data, resulting in more market competition and lower prices for patients. President Trump’s executive orders aim to bring similar common-sense reforms to the American healthcare system.
Congressional Support for Reform
The U.S. Congress, particularly through the Senate Judiciary Committee, has proposed several pieces of legislation to accelerate generic and biosimilar drug approvals while limiting anti-competitive practices by pharmaceutical companies. These bills focus on easing market entry for lower-cost alternatives and addressing tactics that major drug manufacturers use to delay competition. Combined with Trump’s executive orders, these legislative efforts represent the most significant attempt to reform pharmaceutical pricing in decades.
Florida remains the only state that has received FDA authorization for a State Importation Program (SIP) under current regulations, but progress has stalled due to bureaucratic roadblocks. The May 2025 executive order suggests personal importation from developed nations as an alternative approach to state-based programs, potentially opening new avenues for Americans to access affordable medications. By streamlining the biosimilar approval process and eliminating unnecessary barriers, Trump’s administration aims to deliver on its promise of lower drug prices and improved healthcare access for all Americans.
