Now, a spate of low-cost alternatives is entering the market.
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.
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At least nine Humira biosimilars are entering the market this year and most entered the market in July.
Its not clear exactly how successful the unbranded versions of Humira will be.
How Do Humira Biosimilars Compare to the Original?
On a molecular level, the biosimilars are all about the same.
There is a small amount of difference that the FDA accepts.
The biosimilar products can differ slightly by dosage, concentration, and administration route.
Many of the new biosimilar products are low concentration and citrate-free.
They can also vary in concentration and what kind of injection gear they use.
Biosimilars usually arent tested in clinical trials for each of these patient populations, Snow said.
Biosimilarscould save an estimated$180 million in the next five years.
How Would a Patient Switch to Biosimilars?
In many cases, the provider may explain the switch and write a new prescription.
Some biosimilars are considered interchangeable.
All biosimilars manufacturers must prove their product mimics the drug they reference.
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.
Pharmacists can swap Humira for an interchangeable biosimilar without a new prescription from a provider.
Its 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.
Its not that theres any great evidence-based reason for that.
Will Biosimilars Cut Drug Costs for Patients?
Most insurance plans will update which drugs they include in their formulary in January.
Determining how much a customer will ultimately pay for a Humira biosimilar is complicated.
Drug makers set a list price.
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 than80% lessthan the brand name price.
A lower list price doesnt always mean a lower cost at the counter.
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 wont matter much.
Meanwhile, those who pay a percentage copay will likely see a greater benefit.
There are so many different insurance plans out there.
Its 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.
Will Biosimilars Become More Popular Than Humira?
For AbbVie, it would be, Were the easy button…. everybodys trying to reference us.
You know what youve got with us.
This is one of the first times that there are so many biosimilars available for a given product.
If anything, thats where some of the hesitation comes from, Skiermont said.
Snow said that patients may experience a nocebo effect when switching to a biosimilar.
A lot of times the new medication gets blamed for changes that may have happened regardless.
There a lot of unknowns in how this is all going play out.
Just call your providers office if you have concerns or questions.
I think communication with them is going to be the most important thing by far, Snow said.
Correction - September 13, 2023: A previous version of this article misattributed Michael Gonzales' quote.
The attribution has been updated.
Rojas-Chavarro LF, de Mora F.Extrapolation: experience gained from original biologics.Drug Discov Today.
2021;26(8):2003-2013. doi:10.1016/j.drudis.2021.05.006
