Biosimilars: 14 questions patients ask their dermatologist
A biosimilar is a newer medication that’s available to treat psoriasis, psoriatic arthritis, and some other conditions. Your dermatologist may talk with you about switching to a biosimilar if you’re using a biologic, or the high cost of a biologic is preventing you from using one.
This article explains what a biosimilar is and answers other questions that patients frequently ask their dermatologists about this medication.
What is a biosimilar?
A biosimilar is a type of medication that’s very similar to one specific biologic medication like adalimumab (Humira®) or infliximab (Remicade®). However, the cost of a biosimilar may be much less than the cost of a biologic.
Biosimilar terms you may encounter
When your dermatologist or pharmacist talks about a biosimilar, you may hear some unfamiliar terms. Here’s what these terms mean:
Reference product: This is the original biologic like adalimumab, etanercept, or infliximab, which the U.S. Food and Drug Administration (FDA) approved.
Interchangeable biosimilar: If your dermatologist prescribes a biologic like adalimumab, you may find that your pharmacist gives you a biosimilar instead of the prescribed biologic. This is much like giving you a generic drug rather than the brand name drug.
When a pharmacist substitutes a biosimilar for a biologic, they are giving you a biosimilar that can be substituted (interchangeable) for the biologic that your dermatologist prescribed.
Not all biosimilars are interchangeable. For a biosimilar to be interchangeable, the medication must be approved for interchangeable status by the FDA.
When you’re given an interchangeable biosimilar instead of the biologic that your dermatologist prescribed, your dermatologist will be notified of this change. The American Academy of Dermatology Association (AADA) worked tirelessly to make it a requirement that the pharmacist notify the doctor of this change.
Why are biosimilars being developed?
Biosimilars like generic drugs usually make the medication more affordable.
When a medication costs less, it can become an option for patients who previously couldn’t afford the medication. It also saves insurance providers money.
Is a biosimilar the same thing as a generic drug?
Biosimilars and generics are a lot alike, but they’re not the same thing.
They’re alike in that they are both:
FDA approved
Usually more affordable than the original medication
However, a biosimilar is not the generic version of a biologic. A generic medication is an exact copy of the original medication.
A biosimilar cannot be an exact copy of a biologic. Both biologics and biosimilars are made from living cells. Just like no two people are the same, no two living cells are the same. That’s why we say that biosimilars are “very similar” or “highly similar” to a biologic.
Can my dermatologist prescribe a biosimilar if I’ve never taken a biologic?
Yes. If a biosimilar is an appropriate treatment choice, a patient who has never been treated with a biologic can be treated with a biosimilar.
Before prescribing a biosimilar, your dermatologist will carefully consider your health, the condition to be treated, how your current treatment plan is working, and other essentials before deciding if a biosimilar is an appropriate medication for you.
Is it safe to switch from a biologic to a biosimilar?
A biosimilar is made to be highly similar to one specific FDA-approved biologic like adalimumab or etanercept. This similarity helps ensure that both the biologic and the biosimilar have the same effect.
Additionally, the FDA has strict guidelines for making biologics and biosimilars. Both medications must go through a review process. Only the medications that pass this review are FDA approved.
We also know that patients in Europe and Canada have been using biosimilars for years. The findings from more than 10 years of using biosimilars in Europe shows that these medications can be used as safely and effectively as the original biologics.
What side effects are possible with a biosimilar?
The possible side effects for a biosimilar are typically highly similar to the possible side effects for the original biologic. Because a biosimilar is not an exact copy of the original biologic, some patients may feel better with the original biologic than the biosimilar. Likewise, it’s possible to feel better on a biosimilar than the original biologic.
It’s also important to know that several FDA-approved biosimilars may be made for one FDA-approved biologic. For example, the FDA has approved several biosimilars for adalimumab. You may feel better on one biosimilar for adalimumab than another.
When switching between biologics or from a biologic to a biosimilar, it’s possible to have a reaction. You may develop a rash where you inject the medication. You may feel tired, have an upset stomach, or experience other side effects.
Have you switched from a biologic to a biosimilar, or from one biosimilar to another?
Tell your dermatologist about any side effects that you experience, even if they seem minor.
Who can switch from a biologic to a biosimilar?
Your dermatologist determines this for each individual patient.
To decide if you should switch, your dermatologist will assess your unique needs. Considerations include the skin condition you’re treating, how well you’re doing on your current treatment plan, and your overall health.
Your dermatologist can tell you if a biosimilar is an appropriate treatment option for you
If it is, your dermatologist will talk with you about safety, benefits, and risks.
What’s involved in switching from a biologic to a biosimilar?
Your dermatologist will talk with you so that you know how to safely switch. If you have any questions, ask.
You’ll also want to read all the information that comes with the biosimilar. This information contains important facts about how to use the biosimilar. If you have any questions after reading this information, contact your dermatologist.
After starting the biosimilar, tell your dermatologist if you:
Experience a side effect
Feel the medication is not working
With side effects, it’s important to know that a side effect may occur shortly after you inject the biosimilar, but not always.
Sometimes, side effects take time to appear. A side effect may occur after you’ve been using the medication for some time, or even after you stop.
Your dermatologist can tell you how to cope with a side effect, which can help you feel better.
Will my insurance cover a biosimilar?
The best way to find out is to check with your insurance carrier.
Before you contact your insurance carrier, it can be helpful to see your dermatologist to find out if a biosimilar is recommended and if so, which one. That way, you’ll have the information you need.
Will a biosimilar save me money?
Biosimilars typically cost less. To find out whether you will save money with a biosimilar, first ask your dermatologist whether a biosimilar is right for you, and if so, which one is recommended. Then check with your insurance provider, which may be:
Your insurance company
Medicare
Medicaid
If you are covered by Medicare or Medicaid, the Centers for Medicare & Medicaid Services (CMS) can generally provide this information.
Why are biosimilars generally cheaper?
When the FDA approves a new medication, the FDA guarantees that it will not approve a generic or biosimilar version of the new medication for a specified number of years. This allows the pharmaceutical company that made it to earn back the money spent researching and developing this medication and to make a profit.
Once the specified number of years passes, the manufacturer and other pharmaceutical companies can submit a generic or biosimilar version of the medication to the FDA. If the FDA approves that medication, it becomes available.
For this newly approved medication to sell, it generally must be less expensive than the original medication.
Can my pharmacist give me a biosimilar instead of the biologic that my dermatologist prescribed?
Yes. In the United States, laws have been passed in all 50 states and Washington, D.C. that allow (or require in certain situations) a pharmacist to give you a biosimilar instead of the prescribed biologic.
To do this, the pharmacist must follow these laws:
Notify your doctor who prescribed the biologic.
Give you an interchangeable biosimilar. Not all biosimilars are interchangeable. For a biosimilar to be interchangeable, the FDA must have granted it interchangeable status during the approval process.
Can my pharmacist give me a different biosimilar than the one my dermatologist prescribed?
No, not without your dermatologist’s permission. Biosimilars may not be substituted without a doctor’s approval.
Still wondering if a biosimilar is right for you?
Ask your dermatologist, who knows whether one may be right for you.
Related AAD resources
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References
Kvien TK, Patel K, et al. “The cost savings of biosimilars can help increase patient access and lift the financial burden of health care systems.” Semin Arthritis Rheum. 2022 Feb;52:151939.
Lu C and Jacob EC. “Biosimilars: Not simply generics.” US Pharmacist. Published 6/18/2019. Last accessed 3/9/2023.
Mysler E, Azevedo VF, et al. “Biosimilar-to-biosimilar switching: What is the rationale and current experience?” Drugs. 2021 Nov;81(16):1859-79.
Ruda RC, Kelly KA, et al. “Real-world outcomes following switching from anti-TNF reference products to biosimilars for the treatment of psoriasis.” J Dermatolog Treat. 2023 Jan;34(1):2140569.
U.S. Food and Drug Administration
“Are you on a biologic? What you need to know about biosimilars.” Last accessed 3/10/2023.
“Biosimilars.” Last updated 12/13/2022. Last accessed 3/10/2023.
Written by:
Paula Ludmann, MS
Reviewed by:
Elaine T. Kaye, MD, FAAD
Ata Moshiri, MD, FAAD
J. Klint Peebles, MD, FAAD
Sanna Ronkainen, MD, FAAD
Last updated: 5/2/23