Humira Gets More Competition
Several biosimilars for the world’s best-selling drug are set to launch in the U.S. in 2023.
Adalimumab — commonly known by its brand name, Humira — is getting more competition this year. Its first “biosimilar” came on the market at the end of January and at least eight more are expected in 2023.
Adalimumab is a biologic , a powerful and costly drug made from living cells. It’s approved to treat several autoimmune conditions in adults and kids, including rheumatoid arthritis , juvenile idiopathic arthritis , psoriatic arthritis , ankylosing spondylitis and Crohn’s disease.
Biosimilars are nearly identical versions of biologics previously approved by the FDA, called “reference products,” such as Humira . They are tested and proven to be equally safe and effective and they have the same potential side effects as their reference product. The variability of living materials makes it impossible to exactly replicate the original biologic; even different batches of the same biologic vary slightly. But the small differences don’t change biosimilars in any meaningful way.
Why Humira Biosimilars Now?
Humira brought in more than $20 billion in 2021 for its manufacturer, AbbVie. Although biosimilars like Amgen’s Amjevita have been marketed in Europe since 2018, patents and exclusivity laws prevented competition in the U.S. Until now. At least eight adalimumab biosimilars are set to hit the market this year, beginning with Amjevita on January 31. Most of the others — Cyltezo , Abrilada , Hadlima , Hulio , Yusimry and Idacio — are expected to launch in July 2023. Sandoz’s Hyrimoz is expected by the end of September.
Common Questions about Humira Biosimilars
Biosimilars for other reference products used for arthritis have been on the market for about seven years, but this is the first time so many have become available at one time. Here are some common questions and concerns:
Are the adalimumab biosimilars approved for the same uses as Humira?
Yes, with two exceptions. They aren’t approved for hidradenitis suppurativa — a painful skin condition — or uveitis, a group of inflammatory eye diseases, because AbbVie still has exclusive rights for certain conditions.
Do the biosimilars have the same injectable forms, doses and concentrations?
Yes and no. Most come as both a prefilled pen or autoinjector and a prefilled syringe. Yusimry and Cyltezo will be available only as a syringe. If you’ve never used a pen or syringe before, your health care provider will teach you how.
Like newer formulations of adalimumab, most of the biosimilars are citrate-free (reducing their sting); most are also low-concentration. Hadlima will have both low and high concentration forms, meaning there is more drug in less liquid for faster injections. Dosages vary among biosimilars; most are 40 mg.
Why would I switch?
Many rheumatologists are reluctant to switch patients who are doing well on their current medication to a different one, although more say they would be willing to start patients who are new to biologics on a biosimilar. Most patients would prefer to stay on the medication that works for them, although some may be interested in trying a biosimilar if it solved a particular out-of-pocket cost problem for them.
Could I be forced to switch?
There are a few scenarios in which you could be required to switch : Your health plan could remove Humira from its formulary or list the biosimilar as a preferred medication, although experts say both are unlikely. Slightly more likely is that your biosimilar could receive an “interchangeable” designation from the FDA. This means the drug has been proven just as safe and effective as the reference product after being switched back and forth multiple times. In states that allow it, pharmacists may be able to substitute a biosimilar for the reference product without telling health care providers or patients. (Such substitutions are illegal in Oklahoma, for example, and considerably restricted in other states). Right now, only one biosimilar, Cyltezo , is designated as interchangeable with Humira.
Is switching safe?
Many studies have looked at the safety of switching to a biosimilar from a reference drug. None have found any differences in safety, efficacy or the ability of a drug to trigger an unwanted immune response. The same holds true for studies focused specifically on adalimumab. A 2022 review of 21 studies involving nearly 3,000 patients found no difference in safety or effectiveness when switching from Humira to eight different biosimilars.
What about side effects?
Biosimilars have the same side effects as the reference drug. The most common side effects of adalimumab are pain and swelling at the injection site. Biologic drugs also increase the risk of serious infections, including tuberculosis and other bacterial and fungal infections.
Have these been studied in children?
If a reference product is approved for pediatric use, the FDA may approve its biosimilar for pediatric use without requiring studies specifically in children. A biosimilar is as safe and effective as its reference drug for any children it is approved to treat.
Information about the pediatric studies for the reference biologic may be included in its biosimilar’s labeling because the FDA has found that the reference product is safe and effective for the approved uses.
Would I have to jump through hoops to switch to a biosimilar?
That depends on your insurance plan, but step therapy and prior authorization may be prerequisites. Experts say most insurance plans will dip their toes in the water slowly, covering one or possibly two adalimumab biosimilars to start.
Will I save money by taking a biosimilar?
It’s hard to say, because it largely depends on your health insurance plan, what drug tier it chooses for biosimilars and the cost-sharing requirements for that tier. Because pharmacy benefit managers and insurance companies determine costs and coverage, patients have little control over what they pay. Contact your insurance company to find out whether it will cover your biosimilar and what your out-of-pocket costs will be.
Are there any ways to save money on biosimilars?
Some biosimilar manufacturers may offer co-pay cards, similar to those offered for reference biologics, which lower out-of-pocket costs. If you’re uninsured or underinsured, ask your doctor about patient assistance programs.
Biologics - Questions to Ask Your Doctor About Biologics & Biosimilars
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