Key takeaways:
Biologics are medications made from living and natural sources, such as cells, tissues, and proteins. Because of how they’re made, biologics don’t have generic versions. Instead, they have biosimilars. Biosimilars are considered just as safe and effective as their original (reference) biologic.
Humira (adalimumab), Remicade (infliximab), and Rituxan (rituximab) are all FDA approved to treat rheumatoid arthritis (RA). They each have their own biosimilars that are approved and available for use, too.
Biosimilars often cost less than their reference biologic. But the most affordable option for you will likely depend on your insurance coverage status and other savings opportunities you may qualify for.
Biologic medications are a rapidly expanding group of medications made from living and natural sources, such as cells, tissues, and proteins. Unlike other medications, biologics don’t have generic versions. But they do have biosimilars, which are very similar to an original (reference) biologic.
Many biosimilars are available to treat people living with autoimmune conditions. Rheumatoid arthritis (RA) is one of the most notable examples. The American College of Rheumatology considers biosimilars to be just as safe and effective as their reference products, and they’re often available at a lower cost.
Here, we’ll look at the FDA-approved biosimilar products of four biologics commonly used to treat RA.
One of the most well-known biologics for RA is Humira (adalimumab). It’s a subcutaneous (under-the-skin) injection you can self-administer once every 1 to 2 weeks. In addition to RA, it’s also approved to treat autoimmune conditions such as ulcerative colitis, Crohn's disease, plaque psoriasis, and more.
Humira has been a game changer for many people, but affordability is a relatively common concern. This is where Humira biosimilars come into the picture. Quite a few Humira biosimilars are now approved and available for use in the U.S. Your insurance plan may prefer to cover Humira or one of these biosimilar alternatives:
Simlandi — just approved in February 2024
All of these biosimilars are approved for RA, just like Humira. A 2021 review found them to be just as safe and effective for RA.
There are also some logistical differences that your prescriber will keep in mind. Some biosimilars are available in different dosages and package sizes. And while Humira is available in starter kits to make your initial dosage easier, this isn’t available for many of the biosimilars. What’s more, not all are approved to treat the same non-RA conditions, and some are made with latex and contain different inactive ingredients.
Remicade (infliximab) is another well-known biologic used for RA and other autoimmune conditions. Like Humira, Remicade’s cost can be a barrier for many people. FDA-approved and available Remicade biosimilars include:
Like all biosimilars, each product was compared with the reference product in clinical studies before being approved and no significant differences were found. And there aren’t any other notable differences. They’re all given intravenously (IV) in a healthcare setting. They have the same dosages as Remicade that are based on your body weight. And they’re infused the same way, too.
Remicade and its biosimilars are typically given as a 2-hour infusion. Most people receive infusions every 8 weeks after they receive their initial starter doses. These are considered “maintenance” infusions.
Good to know: The first subcutaneous version of Remicade was approved in October 2023. It’s called Zymfentra. But, it’s not currently approved for RA. And because it's administered a different way, it’s not technically considered a biosimilar.
Rituxan (rituximab) is a common cancer medication, but it’s also approved to treat RA. If your insurance plan doesn’t cover Rituxan, it may cover a biosimilar. The three current Rituxan biosimilars are:
Like Remicade, Rituxan and its biosimilars are given as IV infusions. They also come in the same strengths as Rituxan and are usually given no sooner than every 4 to 6 months after your initial doses.
What’s more, one large review compared Rituxan to its biosimilars for both RA and non-Hodgkin lymphoma, a type of blood cancer. In both cases, the biosimilars worked just as well as Rituxan and caused similar side effects.
The biggest difference between them is that only Rituxan is approved for a condition called pemphigus vulgaris.
Enbrel (etanercept) is another popular self-injected medication for RA and other autoimmune conditions. There are currently two Enbrel biosimilars, Erelzi and Eticovo. But they’re not available quite yet.
Erelzi and Eticovo are both FDA approved. Erelzi was approved in 2016, and Eticovo was approved in 2019. However, neither one is currently available for use. They aren’t expected to go live until at least 2029, either.
So, why the delay? The answer is patent protection. Amgen, Enbrel’s manufacturer, has defended their patents against both Sandoz and Samsung Bioepis — the manufacturers of the biosimilar competitors. As a result, these manufacturers can’t market their biosimilars until the patent expires.
There are a number of reasons you may choose to receive a biosimilar over a reference biologic — or vice versa. The main reason is likely cost and insurance coverage, but other treatment considerations can play a role, too.
The cost of treatment is one of the most relevant factors to consider. Biosimilars often cost less than their reference biologic — sometimes much less. This isn’t always the case, though. It’s important to look beyond their list prices to see what your actual out-of-pocket costs will be.
If you have health insurance, your plan’s formulary will have a big influence. There are times when your health insurance plan may prefer only to cover a reference biologic — or they may not cover any biosimilars at all. In this case, the reference biologic will have a lower out-of-pocket cost, so that will likely be your best option. But this will all depend on your insurance plan. Biosimilars are getting more and more popular with insurance companies as time goes on.
You’ll also want to consider whether or not manufacturer copay cards are available. These cards work with commercial insurance plans to reduce your copay. If a copay card is available, then it could lower your out-of-pocket costs. Copay cards are available for many RA biologics and biosimilars.
Patient assistance programs are available for most of these biosimilars and reference biologics, too. If you’re uninsured or underinsured and meet other eligibility requirements, your choice between medications may depend on which one has a patient assistance program that you qualify for. Your healthcare team can help guide you through the process.
Your treatment response may be another reason for choosing between a biosimilar and a reference product.
As mentioned, biosimilars aren’t expected to have any differences in side effects or how well they work. But autoimmune conditions can be unpredictable. And everyone is unique. Some people feel like they don’t get the same results with a particular biosimilar, but this is rare. Some people have also reported experiencing more side effects. If you notice any differences, discuss your concerns with your healthcare team. They can help you decide if the reference product or a different biosimilar may be a better choice for you.
Based on your insurance coverage status, health background, and preferences, your healthcare professional can help you decide if you’d benefit more from a biosimilar or reference product.
In many cases, yes. You can combine a reference biologic or biosimilar with a more traditional RA medication. For example, methotrexate (Trexall) is combined with many RA biologics and biosimilars. Many people take methotrexate first and then add a biologic or biosimilar if they need another medication to further control their symptoms.
This isn’t always the case. JAK inhibitors, such as Xeljanz (tofacitinib), are another popular treatment for RA. They're sometimes prescribed instead of a biologic or biosimilar. Even though JAK inhibitors aren’t biologics, they shouldn’t be combined with them. This is due to side effect risks.
Biosimilars are available for three rheumatoid arthritis (RA) medications: Humira, Remicade, and Rituxan. Two biosimilars are also FDA approved for Enbrel, but they likely won’t be available in the U.S. until 2029. These RA biosimilars are expected to be just as safe and effective as their reference products. But they often come at a lower cost.
When choosing between a biosimilar and its reference product, you’ll want to think about cost, your response to the medication, and practical issues if you’re using a self-injected product. Contact your healthcare professional if you have any questions about your biologic or biosimilar medication.
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