Imagine needing a life-saving medication, only to discover it costs as much as a new car! That’s the reality for many Americans relying on biologic drugs. But why are these medications so incredibly expensive, and could the policies of former President Trump actually bring those costs down? Let’s dive in.
During his time in office, President Trump made lowering prescription drug prices a major priority. He explored various strategies, from negotiating deals directly with pharmaceutical giants to pushing for regulatory changes aimed at boosting the availability of cheaper alternatives.
One key component of his plan involved directing the Food and Drug Administration (FDA) to streamline its approval process for what are known as “copycat” drugs – specifically, generic drugs and, more importantly for our discussion, biosimilar drugs.
Before we go further, it’s worth noting some of the specific actions taken during Trump’s presidency. For example, the administration launched a website intended to provide pricing transparency and announced specific agreements with companies like AstraZeneca regarding drug costs. These actions were all aimed at addressing the broader issue of affordability.
But here’s where it gets controversial… Did these efforts actually work? Did they truly translate into significant cost savings for patients? We’ll explore that shortly.
What are Biologics, Anyway?
Biologics, short for biological medications or products, represent a cutting-edge class of drugs. They’re not your typical pills; instead, they’re complex molecules derived from living organisms, like cells or tissues. Think of them as highly sophisticated therapies that can target diseases at a very specific level. This category includes things like vaccines, blood products, gene therapies, and tissues. They are frequently used to treat challenging conditions such as cancer, autoimmune diseases (like rheumatoid arthritis), and rare disorders. Insulin, used to treat diabetes, is one prominent example of a biologic drug.
Biologics are typically administered via injection or intravenous infusion, meaning they go directly into the bloodstream. According to data from IQVIA, while biologics only account for about 5% of all prescriptions, they represent over half of the total spending on medications in the United States! This stark contrast highlights just how expensive these drugs can be.
And What About Biosimilars?
Biosimilars, as the name implies, are medications that are highly similar to existing, FDA-approved biologic drugs. Think of them as the generic versions of biologics, but with a crucial difference. And this is the part most people miss… Because biologics are so complex and derived from living organisms, it’s virtually impossible to create an exact duplicate. This is unlike traditional generic drugs, which are chemically identical to their brand-name counterparts.
Biosimilars enter the market after the original biologic drug’s patent has expired. They are intended to provide the same clinical effect as the original biologic. A prime example is the biosimilars for Humira, a widely used drug for rheumatoid arthritis. These biosimilars include Cyltezo, Amjevita, and Idacio.
Brian Chen, a health law and economics expert at the University of South Carolina, uses a helpful analogy: “Biologics are like strands of flexible, cooked spaghetti folded in very specific ways, making exact replication nearly impossible.”
The FDA rigorously evaluates biosimilars to ensure they are extremely similar to the original biologic and have no clinically meaningful differences in terms of safety and effectiveness. To gain approval, manufacturers must demonstrate that patients using the biosimilar do not experience any new or worsening side effects compared to those using the original biologic.
The approval process for biosimilars is also lengthy, although typically shorter than that of original biologics, often taking around five to six years. By introducing competition into the market, biosimilars can incentivize the original biologic manufacturers to lower their prices.
The Price Tag: A Breakdown
Let’s get down to brass tacks: how much do these medications actually cost? The answer, unfortunately, is “a lot.” Exact costs vary depending on the specific drug, insurance coverage, and negotiated rates.
A 2018 study estimated that biologics and biosimilars can cost a patient anywhere from $10,000 to $30,000 per year, on average. Humira, for example, was listed at roughly $6,922 for a one-month supply in late 2025. While the biosimilar Cyltezo advertises a 5% discount compared to Humira, the cost can still be substantial. However, a non-brand name option of Cyltezo may be available for around $550 if paying cash through apps like GoodRx.
Generally, biosimilar prices tend to be 15% to 35% lower than their brand-name biologic counterparts. However, the FDA suggests that some biosimilars produce a more dramatic cost savings of 50% on average.
Why So Expensive? The Root Causes
So, what’s driving these sky-high prices? The primary reason boils down to the complexity of developing and manufacturing biologics and biosimilars.
Consider this: producing a simple over-the-counter medication like aspirin might require just a handful of ingredients. In contrast, manufacturing insulin, a biologic, involves complex genetic modifications to living organisms. These intricate processes and the proprietary information involved make it incredibly difficult for competitors to create alternative versions.
As of mid-2025, there were 226 marketed biologics in the US, compared to only 76 approved biosimilars. For context, the FDA has approved over 32,000 generic drugs – far more than the number of brand-name drugs.
Biosimilars: A Safe and Effective Alternative?
The good news is that, yes, biosimilars can be used in place of their original biologic counterparts. The FDA requires all biosimilars to meet stringent standards, ensuring they are highly similar and have no clinically meaningful differences from the original FDA-approved biologic.
Trump’s Plan: Streamlining the Approval Process
President Trump’s administration aimed to reduce the cost of biologics in part by streamlining the FDA approval process for biosimilars. The proposed changes focused on reducing the number of tests required to demonstrate that a biosimilar is as safe and effective as its biologic counterpart.
Under the draft guidance, manufacturers would no longer necessarily be required to conduct comparative clinical trials, which can be time-consuming and expensive. Instead, they could potentially rely on other data, such as comparative analysis, immune response data, and human study data, to demonstrate the drug’s similarity to the original biologic.
The goal was to incentivize drug manufacturers to develop biosimilars more quickly by eliminating redundant and costly clinical studies. This, in theory, could lead to more biosimilar options and increased competition in the market.
Will It Work? The Million-Dollar Question
Here’s the catch: even if the FDA approval process is streamlined, it’s not guaranteed to significantly lower prices for patients. A report from the U.S. Department of Health and Human Services suggests that multiple biosimilar options need to be available to drive down prices substantially.
And this is a HUGE point! A 2024 study in the JAMA Health Forum found that out-of-pocket costs for biologics often increased or remained stable even after biosimilars became available! Patients using biosimilars didn’t necessarily pay less than those using the original biologics.
One major reason for this is the complex system of rebates offered by biologic manufacturers to pharmacy benefit managers (PBMs). These rebates can incentivize insurers to favor the brand-name biologic, even if a cheaper biosimilar is available. These “rebate walls” effectively prevent the sale of cheaper biosimilars.
Other Hurdles: Patents and Lawsuits
Even with a streamlined approval process and multiple biosimilar options, another significant hurdle remains: patent disputes. Brand-name biologic manufacturers often hold numerous patents and file lawsuits to block approved biosimilars from being commercially marketed.
A 2018 study found that of 12 FDA-approved biosimilar products, only five were commercially available at the time due to patent disputes.
The Bottom Line: A Complex Issue with No Easy Answers
Lowering the cost of biologic drugs is a complex challenge with no simple solutions. While streamlining the FDA approval process for biosimilars could potentially increase competition and drive down prices, factors such as rebate walls and patent disputes can still prevent patients from accessing more affordable medications.
Ultimately, whether President Trump’s proposed changes will truly lead to significant cost savings for patients remains to be seen. It’s a multifaceted issue that requires a comprehensive approach, addressing not only the regulatory process but also the complex dynamics of the pharmaceutical market.
What do you think? Will these regulatory changes actually lower drug prices? Or are there more fundamental issues that need to be addressed? Share your thoughts and opinions in the comments below!