The FDA Made It Easier to Approve Biosimilars. Here Is What That Means If You Take a Biologic.
The FDA Made It Easier to Approve Biosimilars. Here Is What That Means If You Take a Biologic.
5 minute read
In March 2026, the FDA announced new steps to further streamline biosimilar development and make biologic medicines more affordable.¹ This announcement continues a policy direction the agency has been pursuing for several years, and it has real implications for anyone who takes a specialty biologic, whether that is Humira for inflammatory disease, Rituxan for cancer or autoimmune conditions, or any of the other high-cost biologics that are now generating biosimilar competition.
The Humira story is the one that started all of this in motion, and it is still unfolding in ways that affect patients today. Understanding what biosimilars are, how the market has evolved, and what it means for your coverage can help you navigate a landscape that is shifting faster than most insurance policies have kept up with.
What Is a Biosimilar and Why Does It Matter?
A biosimilar is a biological medication that is highly similar to an already-approved reference biologic and has no clinically meaningful differences in safety, purity, or potency.² It is not a generic in the traditional sense, because biologics are complex living molecules that cannot be precisely copied the way a small-molecule drug can be. But biosimilars go through an extensive FDA approval process to demonstrate they are equivalent for clinical purposes.
The significance of biosimilars is cost. Biologic drugs are among the most expensive medications in the healthcare system. Humira, for example, had a list price exceeding $6,000 per month before biosimilar competition arrived. When biosimilars enter the market, they create downward pricing pressure that ultimately affects what insurers pay, what patients pay, and how plans design their formularies.
The Humira Biosimilar Landscape
Humira (adalimumab) lost its U.S. patent protection in 2023, and a wave of biosimilar competitors has been entering the market since then. Multiple adalimumab biosimilars are now FDA-approved and commercially available, including Hadlima, Hyrimoz, Cyltezo, and several others.
The practical impact for patients has been uneven, and in many cases confusing. Here is what has actually happened.
Many major pharmacy benefit managers and insurers moved adalimumab biosimilars to preferred formulary positions ahead of or alongside Humira. For patients already on Humira, this sometimes meant receiving notification that their plan now requires them to switch to a biosimilar as a condition of continued coverage at their existing cost-sharing tier.
These forced-switch situations are where many patients have experienced difficulty. The clinical literature supports the safety and efficacy of switching from a reference biologic to its biosimilar for most patients, but individual responses can vary, and not every patient or physician feels comfortable with an insurer-mandated switch that was not initiated for clinical reasons.
If you received a notification that your plan is changing your Humira coverage in favor of a biosimilar, here is what you are entitled to do.
Request the specific clinical coverage criteria. Your insurer must be able to explain what coverage criteria support the formulary change. You can request this documentation in writing.
Ask your physician about a medical necessity exception. If your physician believes switching is not appropriate for you specifically, they can submit a medical necessity exception request with clinical documentation. This is not guaranteed to be approved, but it is the correct formal step.
Understand your appeal rights. If your request for an exception is denied, that denial is appealable through your plan's internal appeal process and, if necessary, through external review.
What the New FDA Streamlining Steps Mean for the Future
The March 2026 FDA announcement focused on reducing the regulatory burden for biosimilar development, with the goal of bringing more affordable alternatives to market faster.¹ This has two likely downstream effects for patients.
More competition, more formulary complexity. As more biosimilars enter the market for drugs like Rituxan (rituximab), Stelara (ustekinumab), Eylea (aflibercept), and others on Ellen's list, insurers will face similar formulary management decisions as they faced with Humira. You may receive notices about preferred-biosimilar requirements for medications beyond adalimumab in the coming years.
Prices for reference biologics may not fall automatically. One of the more counterintuitive findings from the Humira biosimilar experience is that the reference drug's list price does not always drop significantly when biosimilars arrive. Manufacturers often use rebate strategies to maintain formulary position for the reference drug, meaning the gross price stays high but net prices after rebates are negotiated differently with each plan. Whether you pay less depends on your specific plan's approach, not just on whether a biosimilar exists.
Interchangeable biosimilars have specific rules. The FDA designates some biosimilars as "interchangeable," meaning a pharmacist can substitute them for the reference biologic without the prescribing physician's separate approval, similar to generic substitution. Not all biosimilars have this designation. If your plan is substituting a biosimilar and you are concerned about whether interchangeability has been established, ask your pharmacist or physician to confirm the FDA's interchangeability designation for the specific product being substituted.
Questions to Ask Your Insurance Plan Right Now
If you take any specialty biologic, these are the questions worth putting to your plan proactively, before any formulary change notification arrives.
Is my current medication on the current formulary at the same tier it was last year? Formulary tier changes at plan renewal are legal and common. Catching one early gives you more time to respond.
Has my plan added a biosimilar requirement for my drug category? Ask specifically whether there is a preferred-biosimilar requirement and whether your current medication is subject to it.
If I am required to switch, what is the process for a medical necessity exception? Knowing the process in advance is much easier than navigating it urgently when you receive a denial notice.
Frequently Asked Questions
Is a biosimilar the same as a generic?
Not exactly. Both biosimilars and generics offer more affordable alternatives to brand-name medications. But generics are chemically identical small molecules, while biosimilars are highly similar but not identical biological molecules. The FDA holds biosimilars to a rigorous approval standard to demonstrate they have no clinically meaningful differences from the reference biologic in safety, purity, and potency.²
Can my insurer force me to switch from Humira to a biosimilar?
Your insurer can change its formulary in ways that make a biosimilar the preferred option at lower cost-sharing, which effectively creates financial pressure to switch. A true forced substitution at the pharmacy without your physician's involvement would depend on whether the biosimilar has been designated as interchangeable by the FDA. If a switch occurs without your knowledge or your physician's involvement, that is worth documenting and potentially appealing.
If I have done well on Humira for years, should I be concerned about switching?
This is a clinical question for your physician. The clinical evidence supporting biosimilar switching is generally reassuring for most patients in most biologic classes. But your physician is the right person to evaluate whether your specific clinical situation warrants an exception request.
What is the FDA's role versus my insurance plan's role in biosimilar substitution?
The FDA determines whether a biosimilar is approved and whether it is designated interchangeable. Your insurance plan determines what is on its formulary and at what cost-sharing tier. These are separate decisions. FDA approval does not mandate insurer coverage, and insurer formulary policies are not the same as FDA clinical guidance.
Ellen can help you understand a formulary change notice, find the coverage criteria your insurer is applying to biosimilar switches, and draft an exception request if your physician supports one. Start here.
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