What You Need to Know About Humira's Low-Cost Competitors
Fact checked by Nick Blackmer
Key Takeaways
At least nine Humira biosimilars are coming to market, along with promises of lower costs for patients.
A biosimilar is highly similar to a biologic medication that's already been approved by the FDA. It has the same safety and effectiveness as its reference drug.
But due to complications in drug pricing, it’s not yet clear how much cheaper the unbranded versions of Humira will be, nor how much control patients will have in choosing between them.
Humira (adalimumab) has long been one of the top-selling drugs for rheumatoid arthritis and other inflammatory diseases. Now, a spate of low-cost alternatives is entering the market.
These alternative drugs called biosimilars are essentially generic forms of biologics, a class of prescription drugs that are grown in cells. As the name implies, biosimilars are highly similar to the reference biologic in their structure and function.
Humira comes at a list price of $7,000 per month and can be expensive even with insurance. But legal protections on Humira expired this year, granting other drugmakers the opportunity to sell nearly identical versions of the drug without the brand name or high price tag.
At least nine Humira biosimilars are entering the market this year and most entered the market in July.
It’s not clear exactly how successful the unbranded versions of Humira will be. But as insurers begin to cover the biosimilars and providers become comfortable prescribing them, patients could soon start seeing a big cost cut in their prescriptions.
Related: Low-Cost Biosimilar Is Set to Disrupt the Drug Market
How Do Humira Biosimilars Compare to the Original?
On a molecular level, the biosimilars are all about the same. They’re all adalimumab, the drug behind Humira, and they work by blocking the protein tumor necrosis factor (TNF), which causes inflammation.
“There is a small amount of difference that the FDA accepts. But when you look at it from a biochemical standpoint—and there are many litmus tests they go through—they are indistinguishable,” said Marcus Snow, MD, associate professor of rheumatology at the University of Nebraska Medical Center and chair of the American College of Rheumatology’s Committee on Rheumatologic Care.
The biosimilar products can differ slightly by dosage, concentration, and administration route. In 2018, Humira launched a high-concentration version of its medication without citrate, a stabilizing chemical that causes a burning sensation in some patients. Many of the new biosimilar products are low concentration and citrate-free.
Related: FDA Approves the First Interchangeable Biosimilar for Humira
They can also vary in concentration and what kind of injection device they use. Providers can choose a biosimilar based on their preference or the patient’s preference, but the clinical efficacy is the same.
Each of the approved biosimilars is indicated for most of the conditions for which Humira is approved, including rheumatoid arthritis, psoriatic arthritis, and Crohn’s disease. Biosimilars usually aren’t tested in clinical trials for each of these patient populations, Snow said. Regulators instead extrapolate that the new products will work as well as the biologic in treating those conditions because the drugs are so biochemically similar.
Takeaway
Biologics make up nearly half of U.S. drug spending, though they comprise less than 3% of prescriptions, according to the Food and Drug Administration (FDA). Biosimilars could save an estimated $180 million in the next five years.
How Would a Patient Switch to Biosimilars?
The main reason a provider might put a patient on a biosimilar is to help them cut costs on their medication. In many cases, the provider may explain the switch and write a new prescription.
However, in some cases, the patients may not know that they will be put on a biosimilar product until they pick it up from the pharmacy, said Kyle Skiermont, PharmD, vice president of Pharmacy and Oncology for Nebraska Medicine and an advisor to the Center for Biosimilars.
Some biosimilars are considered “interchangeable.” All biosimilars manufacturers must prove their product mimics the drug they reference. For a drug to be labeled as interchangeable, drugmakers must conduct additional studies showing that patients can safely and effectively switch between the brand name and their formula.
The interchangeability designation only exists in the U.S. and is only a regulatory designation, not a clinical one. The rules around whether a pharmacist can dispense a biosimilar without a new prescription vary by state.
Related: Biosimilars vs. Biologics for Treating Psoriatic Disease
“As far as a clinical difference, it is remarkably unlikely that a patient would see any difference whether it’s an interchangeable product or one of the many that are not interchangeable,” Skiermont told Verywell.
Pharmacists can swap Humira for an interchangeable biosimilar without a new prescription from a provider. If a product is not considered interchangeable, but there’s another biosimilar that is covered by insurance at that pharmacy, the pharmacist must get a new doctor’s order before they can fill it.
It’s unlikely that a patient will be switched to a biosimilar without their knowledge. If a biosimilar is considered interchangeable, however, they may be switched without their input, Skiermont said.
There’s no evidence that switching from Humira to a biosimilar and back again multiple times will be less effective or safe for patients, Skiermont said. But some providers will prefer to keep their patients on Humira because they’re familiar with the drug and know it will work for their patients.
Providers tend to be more comfortable offering biosimilars if a patient is newly diagnosed and is taking adalimumab for the first time.
“If a patient has been on the originator product for years and years and has had good results from it, that’s where there’s been a little bit more hesitation from a switching perspective,” Skiermont said. “It’s not that there’s any great evidence-based reason for that. It’s just that with any provider, when you have somebody who has been stable on a medication, if you don’t need to make changes, why would you?”
Related: Top 10 Biologic Drugs in the United States
Will Biosimilars Cut Drug Costs for Patients?
Most insurance plans will update which drugs they include in their formulary in January. So, despite the abundance of Humira biosimilars on the market now, most won’t be available to patients through their insurance for several more months.
Determining how much a customer will ultimately pay for a Humira biosimilar is complicated. Drug makers set a list price. Then, pharmacy benefit managers (PBMs) act as middlemen who negotiate with drugmakers and pharmacies on behalf of insurance providers, employers, and Medicare part D drug plans. They influence which drugs show up on formularies, negotiate rebates and discounts from manufacturers, and help manage pharmacy reimbursements.
Amgen launched the first Humira biosimilar, called Amjevita, earlier this year. The list price for one version of Amjevita is just 5% lower than the Humira price. Meanwhile, others have launched with more than 80% less than the brand name price.
Related: Americans Owe $140 Billion in Medical Debt. Here’s How to Avoid It
A lower list price doesn’t always mean a lower cost at the counter. In some cases, PBMs offer high rebates for products with a high list price, which means the total cost to patients could be lower than that of a product with a low list price.
“Pharmacy benefit managers determine what formularies are and they determine which version of adalimumab we’re going to be able to prescribe to our patients,” Snow said. “I can prescribe any one I want, but if the cost difference is $50 a month versus $10,000 a month, there’s really no choice.”
The total cost to a patient also depends on their insurance coverage, he added. For someone paying a set copay for their medication, the list price likely won’t matter much. Meanwhile, those who pay a percentage copay will likely see a greater benefit.
“There are so many different insurance plans out there. It’s really tough to paint anything with a singular brush,” Snow said.
The success of a biosimilar in the market at large will not necessarily translate to an improvement for patients.
“The overall health care dollars being spent on Humira and its biosimilars are coming down, not necessarily coming down from a patient’s out-of-pocket perspective,” Skiermont said.
Related: Are Generic Drugs as Safe and Effective as Brand-Name?
Will Biosimilars Become More Popular Than Humira?
Even with multiple biosimilar options on the market, there’s no guarantee that patients or providers who are comfortable using Humira will be quick to switch to a new biosimilar, Alex Brill, MA, CEO of the consulting firm Matrix Global Advisors, said in a STAT News panel in July.
“For AbbVie, it would be, ‘We’re the easy button…. everybody’s trying to reference us. You know what you’ve got with us. Plus, we’ll still offer full support for your patients—all the education, onboarding, $5 copay cards, and so forth,’” Brill said.
Skiermont said the real challenge will be to explain biosimilars to patients in a way that makes them feel comfortable with the safety and efficacy of the product.
He said he expects to see little to no pushback from newly diagnosed patients who are starting on the drug for the first time and aren’t yet familiar with Humira in their own care. Patients who are comfortable with their autoinjector or the formulation they’ve been using for years may feel more resistant to change unless there’s a major cost difference.
“This is one of the first times that there are so many biosimilars available for a given product. If anything, that’s where some of the hesitation comes from,” Skiermont said.
Snow said that patients may experience a “nocebo effect” when switching to a biosimilar. Different from a placebo, a nocebo may be blamed for a perceived worsening of symptoms because the patient considers it to be an inferior medication.
“If you’re cruising along on Humira and all of a sudden you go to the pharmacy to pick up a medication and it’s supposed to be Humira but it looks different and the injector is different. And then you go home and the next week your arm starts to hurt and your hands start to hurt, your mind is going to say, ‘it’s a new medication, it’s not working,’” Snow said. “A lot of times the new medication gets blamed for changes that may have happened regardless.”
Finding the best adalimumab option for each patient will depend on their health needs, insurance coverage, and preferences.
“There a lot of unknowns in how this is all going play out. Just call your provider’s office if you have concerns or questions. I think communication with them is going to be the most important thing by far,” Snow said.
Related: Drugs Cost Over Twice As Much in the U.S. Than in Other Countries, Report Finds
What This Means For You
If you're currently taking Humira, talk to your doctor about your treatment options and whether switching to a biosimilar product can save you money. Your insurance provider will also be able to tell you which products are covered by your plan and your pharmacist can answer questions about the differences between Humira and unbranded versions.
