Avsola vs. Remicade: Differences, similarities & side effects

In this article:

• Avsola vs. Remicade: Key differences
• Avsola vs. Remicade: Conditions treated
• Is Remicade better than Avsola?
• Avsola vs. Remicade: Insurance coverage and cost comparison
• Avsola vs. Remicade side effects
• Compare Avsola vs. Remicade drug interactions
• Avsola and Remicade drug warnings
• Switching from Remicade to Avsola

In this article

• Avsola vs. Remicade: Key differences
• Avsola vs. Remicade: Conditions treated
• Is Remicade better than Avsola?
• Avsola vs. Remicade: Insurance coverage and cost comparison
• Avsola vs. Remicade side effects
• Compare Avsola vs. Remicade drug interactions
• Avsola and Remicade drug warnings
• Switching from Remicade to Avsola

Avsola and Remicade are two biologic drugs used to treat various autoimmune inflammatory conditions, such as rheumatoid arthritis, plaque psoriasis, Crohn’s disease, and others. They are in a group of medications called tumor necrosis factor (TNF)  alpha blockers and are in the same drug class as Humira (adalimumab). They work by blocking the actions of TNF, a substance that causes inflammation in the body. Avsola is a biosimilar to Remicade, which means it is highly similar in terms of uses, safety, and efficacy. Continue reading to learn more about Avsola and Remicade. 

Avsola vs. Remicade: Key differences

Remicade, made by the pharmaceutical company Janssen Biotech, was approved by the Food and Drug Administration (FDA) in 1998. It is classified as both a biologic drug and a monoclonal antibody. Biologics are made from natural sources, like humans or animals, and are often produced using biotechnology. According to the FDA, most biologics are complex mixtures that cannot be easily characterized or identified. This is different from nonbiologic drugs that have a known chemical structure. 

Because Remicade is a biologic, it does not have a traditional generic version. Rather, Remicade is known as a reference drug, and Avsola is known as a biosimilar drug. Other approved biosimilars of Remicade include Inflectra and Renflexis.

Amgen’s Avsola, according to a press release, received FDA approval as a biosimilar to Remicade in 2019.

A biosimilar is an almost identical copy of the approved biologic drug—in this case, Remicade. Due to the complexity of biologics, biosimilars cannot be exactly the same as their reference product, unlike traditional brand and generic drugs. However, biosimilars are made of the same active ingredient, work the same way, and have the same mode of administration (such as infusion) and dosing as the reference product. Before a biosimilar can be approved by the FDA, it must undergo clinical trials to ensure there are no clinically meaningful differences in terms of safety and efficacy as the reference drug. 

As seen in the chart below, Avsola and Remicade are TNF blockers given by intravenous infusion (infusion into a vein). They can be used in adults—and for certain indications, they can be used in children 6 years and older.

Compare Avsola vs. Remicade key differences
	Avsola	Remicade
Drug class	TNF blocker	TNF blocker
Brand/generic status	Biosimilar	Brand (also known as reference drug)
What is the generic or brand name?	Avsola is biosimilar to Remicade (the term biosimilar is used when discussing biologic drugs, rather than generic).	The active ingredient is called infliximab. There are no generics of biologics like Remicade. Instead, there are biosimilars, which means they are highly similar to Remicade.
What form(s) does the drug come in?	Injection (intravenous infusion)	Injection (intravenous infusion)
What is the standard dosage?	Depends on weight and condition treated	Depends on weight and condition treated
How long is the typical treatment?	Varies	Varies
Who typically uses the medication?	Adults and children 6 years and older for pediatric Crohn’s disease or pediatric ulcerative colitis	Adults and children 6 years and older for pediatric Crohn’s disease or pediatric ulcerative colitis

Avsola vs. Remicade: Conditions treated

Avsola and Remicade are FDA approved to treat the same conditions, typically after having an inadequate response to conventional therapy (standard treatment). These include adult patients with moderate to severe Crohn’s disease (including those with fistulizing disease), moderate to severe ulcerative colitis, moderate to severe rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis (PSA), and severe plaque psoriasis that is extensive or disabling. Crohn’s disease and ulcerative colitis are types of inflammatory bowel disease (IBD).

Avsola and Remicade are also FDA approved for pediatric patients ages 6 years and older with pediatric Crohn’s disease or pediatric ulcerative colitis.

Compare Avsola vs. Remicade conditions treated
Condition	Avsola	Remicade
Crohn’s disease (adults)	Yes	Yes
Pediatric Crohn’s disease (in patients 6 years and older)	Yes	Yes
Ulcerative colitis (adults)	Yes	Yes
Pediatric ulcerative colitis (in patients 6 years and older)	Yes	Yes
Rheumatoid arthritis (adults) in combination with methotrexate	Yes	Yes
Ankylosing spondylitis (adults)	Yes	Yes
Psoriatic arthritis (adults)	Yes	Yes
Plaque psoriasis (adults)	Yes	Yes

Is Remicade better than Avsola?

Because Avsola is considered highly similar to Remicade, they are considered to be essentially the same in terms of safety and efficacy. They are also FDA approved for the same indications. Clinical studies have determined Avsola to be highly similar to Remicade, allowing it to be approved as a biosimilar. Research performed in various clinics concluded that using a biosimilar, such as Avsola, is financially beneficial since biosimilars often cost much less than the reference drug and are as safe and effective.

Only your healthcare provider can determine which medication is best for you, taking various considerations into account. Consult your healthcare provider for professional medical advice on the best treatment for your condition.

Avsola vs. Remicade: Insurance coverage and cost comparison

Avsola and Remicade are typically billed through medical insurance or Medicare Part B as a medical cost by the location where you get the infusion, such as a healthcare provider’s office, infusion center, or hospital. In some cases, Avsola and Remicade may be filled at a specialty pharmacy. 

In cases where your infusions are administered along with other prescription drugs, a Medicare Part D prescription plan or Medicare Advantage plan may contribute toward the cost of these medications. For specifics, you can contact your Medicare plan to find out more about the cost of Avsola and Remicade. 

RELATED: How much does Medicare pay for Remicade infusions?

Compare Avsola vs. Remicade cost & coverage
	Avsola	Remicade
Typically covered by insurance?	Varies	Varies
Typically covered by Medicare Part D?	Coverage varies	Coverage varies
Quantity	Varies	Varies
SingleCare cost	N/A	N/A

Avsola vs. Remicade side effects

According to the prescribing information, the most common side effects of Avsola and Remicade are infections (including upper respiratory, sinus, and throat infections), infusion reactions, headache, and abdominal pain. 

This is not a full list of side effects, and others may occur. Consult your healthcare provider for a full list of side effects. 

Compare Avsola vs. Remicade side effects
	Avsola		Remicade
Side effect	Applicable?	Frequency	Applicable?	Frequency
Upper respiratory tract infection	Yes	32%	Yes	32%
Nausea	Yes	21%	Yes	21%
Headache	Yes	18%	Yes	18%
Sinus infection	Yes	14%	Yes	14%
Stomach pain	Yes	12%	Yes	12%
Sore throat/throat infection	Yes	12%	Yes	12%
Cough	Yes	12%	Yes	12%
Bronchitis	Yes	10%	Yes	10%
Rash	Yes	10%	Yes	10%
Indigestion	Yes	10%	Yes	10%
Fatigue	Yes	9%	Yes	9%
Reactions related to infusion of drug	Yes	20%	Yes	20%

Source: Avsola (DailyMed), Remicade (DailyMed) 

Avsola and Remicade drug interactions

Before taking Avsola or Remicade, tell your healthcare provider about all of the medications you take, including prescription drugs, over-the-counter medicines, vitamins, and supplements. 

Neither Avsola nor Remicade should be combined with other biological products used to treat the same conditions. Doing so could increase the risk of serious infections and other complications. 

Avsola or Remicade can also interact with medicines that have a narrow therapeutic index. A narrow therapeutic index means that a drug has a small window between being safe and toxic. Examples of these drugs include Coumadin (warfarin), cyclosporine, and theophylline. 

People taking Avsola or Remicade should not receive live vaccines. 

This is not a full list of drug interactions, and others may occur. Consult your healthcare provider for more information about drug interactions and how they may affect you.

Compare Avsola vs. Remicade drug interactions
Drug	Drug class	Interacts with Avsola?	Interacts with Remicade?
Actemra (tocilizumab) Kineret (anakinra)  Orencia (abatacept) Rituxan (rituximab)	Biologics	Yes	Yes
Coumadin, Jantoven (warfarin)	Blood thinner	Yes	Yes
Cyclosporine	Immunosuppressant	Yes	Yes
Theophylline	Xanthine	Yes	Yes
Live viral vaccines (such as the live MMR vaccine, live influenza nasal vaccine, live varicella vaccine) or live attenuated bacteria (such as BCG live intravesical)	Live viral vaccines or live attenuated bacteria	Yes	Yes

Avsola and Remicade drug warnings

Avsola and Remicade have a black box warning, also called a boxed warning, which is the strongest warning required by the FDA. According to the boxed warnings:

• Because they suppress the immune system, Avsola or Remicade may increase the risk of serious infections. Examples of these infections include tuberculosis (TB), bacterial sepsis, and invasive fungal infections, which can lead to hospitalization or death. 
• If a patient develops a serious infection, Avsola or Remicade should be stopped. 
• Before starting treatment with Avsola or Remicade, a TB test should be performed. If the test is positive, TB treatment should begin before starting Avsola or Remicade. During treatment with Avsola or Remicade, patients should be monitored for TB and other infections. 
• Lymphoma and various other cancers, some of which have been fatal, have occurred in children and adolescent patients treated with TNF blockers such as Avsola or Remicade. Some cases of a rare type of T-cell lymphoma called hepatosplenic T-cell lymphoma (HSTCL) have developed in patients taking TNF blockers, and these cases have been aggressive and caused death. Most patients who had HSTCL were also taking azathioprine or mercaptopurine along with the TNF blockers. Most cases occurred in adolescent and young adult males with ulcerative colitis or Crohn’s disease.

Other warnings for both Avsola and Remicade include:

• Hepatitis B virus reactivation: TNF blockers, including Avsola and Remicade, can reactivate the hepatitis B virus (HBV) in chronic carriers. In some cases, reactivation in combination with TNF treatment (and often with other immunosuppressants as well) has caused death. Patients should be tested for HBV before starting Avsola or Remicade. 
• Liver toxicity: TNF blockers may cause severe liver problems. Healthcare providers will monitor liver function during treatment with Avsola or Remicade. Individuals who have symptoms of liver problems (including fatigue, stomach pain, and yellowing of the skin and whites of the eyes) should get immediate medical attention. 
• Heart failure: TNF blockers can cause new or worsening heart failure. People with heart failure should consult their healthcare professional before taking Avsola or Remicade. 
• Hypersensitivity: Avsola and Remicade can cause several types of severe allergic reactions. Symptoms such as hives, trouble breathing, low blood pressure, or swelling around the face require emergency medical attention. In rare cases, Avsola or Remicade may cause serum sickness reactions, with symptoms including fever, rash, headache, sore throat, muscle pain, swelling, and difficulty swallowing. These symptoms also require emergency medical attention. 
• Hematologic reactions: Avsola and Remicade can cause life-threatening or fatal blood problems, such as low white blood cell counts, low platelet counts, and pancytopenia (a deficiency of red blood cells, white blood cells, and platelets). Individuals with symptoms of infection, such as fever, should seek emergency medical attention.
• Neurologic reactions: TNF blockers such as Avsola and Remicade can cause central nervous system (CNS) problems such as seizures, multiple sclerosis, and Guillain-Barré syndrome—and should be used with caution in patients with CNS conditions. 
• Live vaccines: Vaccinations should be up to date before starting treatment with a TNF blocker such as Avsola or Remicade. Live vaccines should not be given to a patient who is taking a TNF blocker, as a serious infection could result. 
• Cardiovascular and cerebrovascular complications: Heart and blood vessel problems during and after Avsola and Remicade infusions have occurred. These include stroke, heart attack, heart rhythm problems, vision loss, and blood pressure changes. If a reaction occurs, the infusion should be stopped immediately, and emergency treatment should be started.

Switching from Remicade to Avsola

If you are interested in switching from Remicade to Avsola, you can consult your healthcare provider. Although Avsola is considered a biosimilar, it is not an interchangeable biosimilar. An interchangeability designation means that the biosimilar can automatically be substituted for the reference product. However, because Avsola is not considered interchangeable, you will need your healthcare provider to specifically order Avsola if you want to switch from Remicade. Because Avsola is highly similar to Remicade, once you switch, it is unlikely that you would notice a difference in how you feel. Consult your healthcare provider for personalized medical advice on your condition and treatment.