Comparing Inflectra (Infliximab-Dyyb) vs. Remicade (Infliximab)
Medically reviewed by Alex Yampolsky, PharmDMedically reviewed by Alex Yampolsky, PharmD
Inflectra (infliximab-dyyb) and Remicade (infliximab) are prescription drugs in the tumor necrosis factor (TNF) alpha inhibitor class. Both drugs work in the same way and are used for the same indications.
Inflectra is a biosimilar to Food and Drug Administration (FDA)–approved Remicade. A biosimilar drug is highly similar to an already FDA-approved biologic drug, referred to as a "reference drug."
A biosimilar must be as safe and effective as the reference product but is usually less expensive than the reference drug.
This article will explain what biosimilar drugs are and compare the similarities and differences between Inflectra and Remicade.
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Inflectra and Remicade: Highly Similar but Not Identical
Inflectra is an FDA-approved biosimilar to Remicade. Remicade was initially licensed in 1998, and Inflectra was approved in 2016.
A biosimilar product is a biological product highly similar to an already-approved biological product (medication made from living organisms), known as a reference product. The biosimilar has the same safety and effectiveness as the reference product.
A biosimilar product has the exact mechanisms of action, routes of administration, dosage forms, and strengths as the reference product. Biosimilars treat the same indications and conditions as approved for the reference drug.
However, there can be some minor differences in inactive components of biosimilar products. These differences are not clinically meaningful.
Inflectra contains the active drug infliximab-dyyb, which is highly similar to infliximab injection and works the same way in the body.
How Do They Work?
Inflectra and Remicade belong to the class of medications called tumor necrosis factor-alpha (TNF-alpha) inhibitors. They block the action of an inflammation-causing protein called TNF-alpha.
People with certain autoimmune diseases, like psoriasis or rheumatoid arthritis, have too much TNF-alpha. This causes the immune system to attack healthy tissues or organs and cause cell death. Inflectra and Remicade can help block the damage caused by too much TNF-alpha in the body.
Main Differences
Inflectra and Remicade are very similar. The only difference is that Inflectra contains the active drug infliximab-dyyb. It is a biosimilar to the reference product infliximab, the main ingredient in Remicade.
Inflectra costs less than Remicade. Usually, biosimilar drugs are cheaper than reference products.
Other Biosimilars to Remicade
Along with Inflectra, other drugs that are biosimilar to Remicade are Avsola (infliximab-axxq) and Renflexis (infliximab-abda).
What Conditions Do They Treat?
Infliximab injection products, including Inflectra and Remicade, are used to relieve the symptoms of certain autoimmune disorders. Autoimmune disorders are conditions in which the immune system mistakenly attacks healthy tissues and organs. These attacks weaken the body or even cause life-threatening problems.
Inflectra and Remicade are FDA-approved to treat:
Crohn's disease in adults and children age 6 and older when conventional treatments are not effective
Ulcerative colitis in adults and children age 6 and older when conventional treatments are not effective
Rheumatoid arthritis in adults
Ankylosing spondylitis in adults
Psoriatic arthritis in adults
Plaque psoriasis in adults when other treatments are not effective. A healthcare professional should monitor people receiving the medication and have follow-up checkups.
Infliximab injection products are also used off-label (for an indication or at a dosage not approved by the FDA) to treat Behcet's disease (ulcers in the mouth and on the genitals and inflammation of other body parts).
Consult your healthcare provider about the possible risks of using infliximab products for your condition.
How Are They Administered?
Inflectra and Remicade are given by a healthcare provider in a clinical setting. Only a healthcare professional should prepare and administer the medicine.
They are administered through a needle placed in a vein (intravenous, or IV, infusion) in the arm and take nearly two hours.
Your healthcare provider may give you other medications before starting Inflectra or Remicade infusion as a way to prevent or lessen side effects. These include histamine receptor antagonists, Tylenol (acetaminophen), or corticosteroids.
Your provider will monitor you for side effects during and after the infusion. If side effects occur, they may need to adjust or stop your infusion or treat your symptoms. They may also perform certain tests while you are receiving the drug to monitor your reaction and how well you respond to the treatment.
Keep regular appointments to get the follow-up doses.
Dosage: How Much Is Given?
Both Inflectra and Remicade have the same dosage regimen for different indications. The doses are given below.
Doses are given more frequently at the beginning of the treatment and less often as the treatment continues.
After an initial dose, the following doses are given after two weeks and six weeks. Later, a maintenance dose is given every eight weeks.
Indication | Dosage for Inflectra | Dosage for Remicade |
Adult Crohn's disease | 5 mg/kg | 5 mg/kg |
Pediatric (aged 6 years) Crohn's disease | 5 mg/kg | 5 mg/kg |
Adult ulcerative colitis | 5 mg/kg | 5 mg/kg |
Pediatric (aged 6 years) Ulcerative Colitis | 5 mg/kg | 5 mg/kg |
Rheumatoid arthritis | 3 mg/kg | 3 mg/kg |
Ankylosing spondylitis | 5 mg/kg | 5 mg/kg |
Psoriatic arthritis | 5 mg/kg | 5 mg/kg |
Plaque psoriasis | 5 mg/kg | 5 mg/kg |
When used for Crohn's disease, the dose can be increased to 10 mg/kg every eight weeks in adults. Your healthcare provider may discontinue Inflectra and Remicade if you do not respond after two weeks.
Do They Have The Same Effectiveness?
The FDA only approves a biosimilar product if it is similar in the mechanism of action, indications, and other features, including effectiveness, to an already-approved biological product.
The FDA approved Inflectra based on a review of evidence that it is similar in terms of safety and effectiveness to the reference product, Remicade.
What Are The Side Effects?
Inflectra and Remicade help treat conditions when other drugs do not improve clinical symptoms. However, some side effects may occur.
Some of the most common side effects of Inflectra and Remicade are:
Coughing
Headache
Sinus infections
Sore throat
Stomach pain
Infusion reactions can occur up to two hours after an infusion. Tell your healthcare provider if you have any of the following signs of an infection while receiving or after receiving Inflectra or Remicade:
Fever
Chills
Chest pain
Low blood pressure (hypotension)
High blood pressure (hypertension)
Shortness of breath
Rash
Itching
The healthcare provider will monitor you during the drug delivery to assess adverse effects. You may be given other medications to treat or prevent adverse reactions.
Side effects that need immediate medical attention include:
Heart failure symptoms, such as shortness of breath, swelling of ankles or feet, or sudden weight gain
Liver injuries, which can cause jaundice (skin and eyes turning yellow due to a buildup of bilirubin in the body), dark brown-colored urine, pain on the right side of your stomach area (right-sided abdominal pain), fever, or extreme tiredness (severe fatigue)
Blood problems, which can cause a fever that does not go away, bruising or bleeding, or pale skin
Nervous system disorders, which can cause changes in vision, numbness or tingling, seizures, or weakness in the arms or legs
Lupus-like syndrome, which can cause chest discomfort or pain that does not go away, shortness of breath, joint pain, or rashes that get worse in the sun.
Safety Precautions
Inflectra and Remicade come with an FDA-boxed warning. Take precautionary measures when required to prevent any severe adverse effects.
There is an increased risk of developing severe infections that can lead to hospitalization or even death. These include tuberculosis (TB), bacterial sepsis, fungal infections, or infections from other pathogens.
Severe or life-threatening cancers, including lymphoma (cancer that begins in the cells that fight infection) in children and young adults.
Tell your healthcare provider if you are pregnant, plan to become pregnant, or are breastfeeding. Consult your healthcare provider if you become pregnant while using Infectra or Remicade. The baby may need to receive certain additional vaccinations after birth.
Tell your healthcare provider if you have or have ever had heart failure (a condition in which the heart cannot pump enough blood to other parts of the body). Your healthcare provider may tell you not to use Remicade, Inflectra, or similar products.
Switching Between Inflectra and Remicade
The biosimilars of Remicade, including Inflectra, Avsola, and Renflexis, are equally effective at treating different conditions.
The results of different studies and clinical trials suggest that the efficacy of biosimilars such as Inflectra is comparable to that of the reference product Remicade in people with RA, AS, and IBD. The results also found that biosimilars are well-tolerated and have a similar safety profile when people switch from Remicade to a biosimilar.
Different studies' data support the safety and efficacy of onetime switching between reference Remicade and biosimilar Inflectra. More clinical studies are required to establish the facts.
However, FDA-approved Inflectra is a biosimilar to Remicade but not interchangeable. It is advisable to consult a healthcare professional while switching between drugs.
Summary
Inflectra is the first FDA-approved biosimilar to Remicade. The main difference between Inflectra and Remicade is their active ingredient. Inflectra contains the active drug infliximab-dyyb. It is a biosimilar version of infliximab, the active drug in Remicade.
A biosimilar drug is highly similar to an already FDA-approved drug called a "reference drug." Inflectra and Remicade are prescription drugs and work similarly for various autoimmune disorders.
These drugs must be used as prescribed. A healthcare professional will administer the drug while monitoring the patient for adverse reactions.
Read the original article on Verywell Health.
