Inflectra vs. Remicade: What's The Difference?

Wondering how Inflectra and Remicade are different? We’ve got you covered with a full run-down of their uses, side effects, efficacy, and cost.

Inflectra and Remicade are two biological medications used to fight chronic inflammatory autoimmune disorders, including Inflammatory Bowel Disease (IBD). 

The U.S. Food and Drug Administration (FDA) approved Pfizer-manufactured Inflectra (infliximab-dyyb) in 2016 as the first biosimilar to Janssen Biotech-manufactured Remicade (infliximab), which was initially licensed in 1998. The word “biosimilar” essentially means a biological product (aka derived from living organisms) that’s highly similar to an already-approved biological product in terms of safety and effectiveness. For instance, Humira (adalimumab), Enbrel (etanercept), and Renflexis (infliximab-abda) have biosimilar uses to treat inflammatory diseases.

In 2019, the FDA approved Avsola (infliximab-axxq) for all approved indications of the reference product, Remicade, for the treatment of: 

• Moderate-to-severe rheumatoid arthritis
• Moderate-to-severe Crohn's disease (adult and pediatric)
• Moderate-to-severe ulcerative colitis (adult and pediatric)
• Chronic severe plaque psoriasis
• Psoriatic arthritis
• Ankylosing spondylitis

Avsola was proven to be highly similar to its reference product with no clinically meaningful differences.

Patients can be confident that biosimilar drugs are high quality and meet the FDA’s rigorous scientific standards. Still, the use case and safety profile of Inflectra vs Remicade deserve further attention.

Top-line differences between Inflectra and Remicade

The FDA approved Inflectra as a biosimilar to Remicade based on the review of clinical safety and effectiveness data.

Both these biologic drugs treat the same autoimmune disorders. They’re infused into your vein and are often given once every six to eight weeks. They both work the same way by blocking a protein called tumor necrosis factor (TNF)-alpha, and there aren’t any clinically meaningful safety or effectiveness differences between them.

However, it should be noted that Inflectra has been approved by FDA as a biosimilar and not an interchangeable product since it isn’t considered chemically equivalent. Your healthcare provider will need to write a new prescription if you’re switching from Remicade since your pharmacist cannot change the prescribed brand name.

Efficacy

FDA-approved Inflectra is a TNF blocker approved for all eligible indications of Remicade and is dosed and delivered the same way as Remicade. Both are administered by intravenous infusion for no less than two hours. 

Clinical studies have found that Inflectra has a similar efficacy and safety profile as the reference product Remicade, not only in rescue therapy but also during a six-month observation period in adult patients with severe ulcerative colitis.

Cost

As of Q3 2020, the average sales price of Remicade was around $483, compared to $457 for Inflectra.

Learn more about the cost of infusion therapy, including how things like site of care and insurance (Medicare included) can play a role. 

Dosage & length of administration

The dosage and administration of both drugs are the same:

• Crohn’s Disease: The recommended dose by the FDA is 5 mg per kilogram (kg) of body weight. Patients will be given one dose every 0, 2, and 6 weeks, then every 8 weeks. 
• Pediatric Crohn’s Disease: 5 mg/kg of body weight every 0, 2, and 6 weeks, then every 8 weeks
• Ulcerative Colitis: 5 mg/kg of body weight every 0, 2, and 6 weeks, then every 8 weeks
• Rheumatoid Arthritis: 3 mg/kg of body weight every 0, 2, and 6 weeks, then every 8 weeks — although some patients may benefit from increasing the dose to 10 mg/kg or receiving treatment as often as every 4 weeks.
• Ankylosing Spondylitis: 5 mg/kg of body weight every 0, 2, and 6 weeks, then every 6 weeks
• Psoriatic Arthritis and Plaque Psoriasis: 5 mg/kg of body weight every 0, 2, and 6 weeks, then every 8 weeks.

Side effects

Inflectra and Remicade may affect your immune system and lower the ability of your body to fight infections. 

Common side effects of Remicade include back and chest pain, nausea, and abdominal pain. Patients may also experience diarrhea, sinusitis, vomiting, and candidiasis. 

Common side effects of Inflectra include dizziness, nasal congestion/runny nose, nervousness, and headaches. In some rare cases, patients may experience hives, weight loss, increased sweating, and muscle aches. Patients who develop rare serious infections may take concomitant immunosuppressants such as methotrexate or corticosteroids. 

Safety

You should not receive these medicines if you have heart failure unless your doctor has examined you and decided that you can receive these drugs — or you had an allergic reaction to any of the ingredients in these drugs, including dibasic sodium phosphate dihydrate, monobasic sodium phosphate monohydrate, polysorbate 80, and sucrose. Also, whether these drugs are safe and effective in children under six is unknown.

Here are some of the things to keep in mind while working with your doctor for the infusion of any of these medicines:

• Tell your doctor about all of your medical conditions (infections, liver problems, heart ailments, cancer, or nervous disorders) so that these prescription drugs can be suggested only after evaluation of other treatment options.
• Be transparent if you are pregnant or plan to become pregnant, are breastfeeding, or plan to breastfeed.
• It is crucial to tell your baby’s doctor and other health care professionals if you have a baby and were receiving these prescription drugs during your pregnancy so they can decide when your baby should receive any vaccine, as certain vaccinations can cause infections.
• Do not take these Inflectra or Remicade with medicines such as KINERET (anakinra), ORENCIA (abatacept), ACTEMRA (tocilizumab), or other biologics used to treat the same conditions. 

The bottom line

Inflectra and Remicade can be effective treatments for various conditions. However, it’s crucial to understand how the treatments work and what to expect. Before beginning treatment, speak with your doctor about infusion therapy's potential benefits and risks.