Remicade biosimilar options for affordable treatment

In this article:

• Understanding Remicade: Uses and mechanisms
• Current approved Remicade biosimilars
• Regulatory guidelines for Remicade biosimilars
• Other Remicade alternatives
• Bottom line: Choosing a Remicade biosimilar

In this article

• Understanding Remicade: Uses and mechanisms
• Current approved Remicade biosimilars
• Regulatory guidelines for Remicade biosimilars
• Other Remicade alternatives
• Bottom line: Choosing a Remicade biosimilar

From a breakthrough drug to standard-of-care treatment, Remicade (infliximab) has a storied history of treating autoimmune disease—when the immune system mistakenly identifies healthy tissues as foreign and initiates an attack. There are more than 80 known autoimmune diseases, some of which are rare and some of which are common, including Type 1 diabetes, lupus, and rheumatoid arthritis. Currently, multiple biosimilars to Remicade are on the market. These can offer you profound effectiveness at a fraction of the price. 

Understanding Remicade: Uses and mechanisms

Remicade was the first tumor necrosis factor-alpha (TNF-alpha) inhibitor to be approved by the Food and Drug Administration (FDA). By intercepting TNF-alpha, the drug blocks the immune system’s signaling pathway, leading to less interferon and immune cell action. The result is a reduction in inflammation in various body tissues. This can make all the difference in autoimmune disease by controlling symptoms and reducing long-term organ damage.

Remicade was first approved for inflammatory bowel disease, namely Crohn’s disease and ulcerative colitis, and the joint disease rheumatoid arthritis. Since then, Remicade has also gained FDA indications for psoriatic arthritis, ankylosing spondylitis, and plaque psoriasis. Healthcare providers sometimes prescribe it for off-label uses as well, including for severe forms of sarcoidosis, pustular psoriasis, and COVID-19.

Although the drug has profound benefits, it also has serious risks. The FDA has placed boxed warnings on Remicade’s drug label, calling attention to the risk of serious infections, like tuberculosis and fungal infections. There’s also a risk of cancer, like lymphoma, in children. You should not get live vaccines during treatment with Remicade, and other vaccines may be less effective. For these reasons, Remicade is sometimes reserved for moderate to severe cases of autoimmune disease as opposed to mild cases.

With its many uses and benefits for moderate to severe autoimmune diseases also comes a steep price. A single dose of Remicade can cost $4,000 to $7,000, which can add up considering that it is typically given on a regular basis, such as every eight weeks for ulcerative colitis. 

When the patent on Remicade ran out, the race was on to build a generic version, but this was not an easy task due to its complexity. To save drug development costs and pass those savings on to consumers, other companies have created FDA-approved biosimilars to Remicade. These biosimilars have slight differences in their molecular structure.

Current approved Remicade biosimilars

To date, three Remicade biosimilar TNF blockers have been approved: Inflectra, Renflexis, and Avsola. Here’s a look at how they compare to Remicade and to each other.

Inflectra

Approved by the FDA in 2016, Inflectra (infliximab-dyyb) was the first biosimilar to Remicade. By the FDA definition of a biosimilar, Inflectra is highly similar to Remicade, aside from minor differences in components without clinical activity and has no clinically meaningful difference in terms of safety, purity, and potency.

The FDA indications and dosing of Inflectra are the same as those of Remicade. The dose is weight-based, typically between 3 and 5 milligrams (mg) per kilogram (kg) of body weight, and is given at intervals dependent on the disease being treated. For instance, in the treatment of ulcerative colitis, the first dose is followed by another two weeks later, another six weeks after that, and every eight weeks thereafter. All doses are intravenous and are given at a medical clinic or infusion center.

RELATED: Remicade infusions: What to expect

According to data from Medi-Span, the Inflectra costs about $1,100 per 100 mg, compared to about $1,400 per 100 mg for Remicade. Just as there would be for Remicade, there may also be additional fees to consider in regard to getting the infusion, such as fees charged by the healthcare provider who administers it.

Renflexis

Renflexis (infliximab-abda) has met the same standards for biosimilars. As a result, it shares the same FDA indications as Remicade and Inflectra, meaning that Renflexis has approval for use in ulcerative colitis, Crohn’s disease, rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, and plaque psoriasis. Dosing is also the same. Using the same pricing reference, Renflexis is listed at about $900 per 100 mg. A 160-pound person getting Renflexis dosed at 5 mg/kg of body weight would pay about $3,200 for the dose, compared to a price of about $5,000 for Remicade.

Avsola

The story is much the same with Avsola (infliximab-axxq). FDA indications and dosing guidelines match those of Remicade, Inflectra, and Renflexis. Keep in mind that all of these biosimilars carry identical boxed warnings about serious side effects, too. The same drug reference quotes a price of $600 per 100 mg for Avsola, making it more than 50% cheaper than Remicade’s referenced price. 

Regulatory guidelines for Remicade biosimilars

As discussed, the FDA has published regulatory guidelines for biosimilars in the United States. The European Medicine Agency (EMA) has its own regulatory language. Likewise, other countries have their own processes. In fact, other Remicade biosimilars exist and are approved elsewhere in the world.

According to the FDA, biosimilars must prove their similarities in preclinical and clinical studies, meaning they are tested in human subjects. They must have similar pharmacological properties and show comparable effectiveness and safety in these studies. Ultimately, once FDA approval is granted for one indication, approval for other indications can be given based on scientific justification. The fast-tracking of approvals reduces research costs and contributes to lower prices for biosimilars.

Remember that these drugs are all antibodies. The slight structural differences in biosimilars can mean that they each elicit a distinct immune response. Our bodies can produce antibodies against any of these monoclonal antibody drugs. Based on the concerns for allergic reactions occurring when switching between Remicade and biosimilars, additional testing and studies are required before a biosimilar is termed interchangeable and to ensure that it is safe and effective to switch to the biosimilar from Remicade.

Other Remicade alternatives

Remicade and its biosimilar products are not your only options for infliximab therapy. The pharmaceutical company Janssen produces both Remicade and unbranded infliximab. Its unbranded drug may cost you less than the brand-name version, similar to the biosimilars. 

Zymfentra is an infliximab product that can be given by subcutaneous injection, thereby permitting dosing at home rather than at a healthcare facility. However, the FDA has only approved it for maintenance therapy for inflammatory bowel disease. 

Besides infliximab products, many other antirheumatics exist. Depending on what autoimmune disease you need treatment for, other blockers of tumor necrosis factor or different biologics could be options. These include Humira (adalimumab), Simponi (golimumab), Entyvio (vedolizumab), Stelara (ustekinumab), Omvoh (mirikizumab), Xeljanz (tofacitinib), Rinvoq (upadacitinib), Zeposia (ozanimod), and Velsipity (etrasimod). Nonbiologics, like the corticosteroid prednisone, may be alternatives, too, in some cases. Rely on your healthcare provider to guide you on the best options for you.

Bottom line: Choosing a Remicade biosimilar

Getting the medical advice of your team of doctors is essential when considering treatment options for autoimmune disease. There is much at stake when considering the nature of autoimmune disease while weighing the pros and cons of Remicade and its biosimilars, the serious nature of their boxed warnings, and the expenses involved. Sometimes, the drug formularies from your insurance company or the availability of a product at your infusion center may dictate which biosimilar is used. Other times, your specialist in gastroenterology, rheumatology, or dermatology may have a preference. Gathering advice and information should help you to make the best choice.