Table of ContentsView AllTable of ContentsHighly Similar DrugsUsesAdministrationDosageAre They Equally Effective?Side EffectsSafety PrecautionsSwitching to the Other
Table of ContentsView All
View All
Table of Contents
Highly Similar Drugs
Uses
Administration
Dosage
Are They Equally Effective?
Side Effects
Safety Precautions
Switching to the Other
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. Abiosimilar drugis 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.
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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 calledTNF-alpha.
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 RemicadeAlong with Inflectra, other drugs that are biosimilar to Remicade are Avsola (infliximab-axxq) and Renflexis (infliximab-abda).
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:
Consult your healthcare provider about the possible risks of using infliximab products for your condition.
How Are They Administered?
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.
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:
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:
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:
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 includetuberculosis (TB), bacterialsepsis, fungal infections, or infections from other pathogens.
Severe or life-threatening cancers, includinglymphoma(cancer that begins in the cells that fight infection) in children and young adults.
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.
A Word From Verywell HealthThere is hesitancy around switching between brand and biosimilar products due to fears over antibody formation and disease flare-ups, but current evidence points toward the interchangeability of these products. Ultimately this decision should be left to patients and their prescribers.—ALEX YAMPOLSKY, PHARMD, MEDICAL EXPERT BOARD
A Word From Verywell Health
There is hesitancy around switching between brand and biosimilar products due to fears over antibody formation and disease flare-ups, but current evidence points toward the interchangeability of these products. Ultimately this decision should be left to patients and their prescribers.—ALEX YAMPOLSKY, PHARMD, MEDICAL EXPERT BOARD
There is hesitancy around switching between brand and biosimilar products due to fears over antibody formation and disease flare-ups, but current evidence points toward the interchangeability of these products. Ultimately this decision should be left to patients and their prescribers.
—ALEX YAMPOLSKY, PHARMD, MEDICAL EXPERT BOARD
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.
8 SourcesVerywell Health uses only high-quality sources, including peer-reviewed studies, to support the facts within our articles. Read oureditorial processto learn more about how we fact-check and keep our content accurate, reliable, and trustworthy.U.S Food and Drug Administration.What is a biosimilar?U.S Food and Administration.FDA approves Inflectra, a biosimilar to Remicade.MedlinePlus.Infliximab injection.Guo Y, Lu N, Bai A.Clinical use and mechanisms of infliximab treatment on inflammatory bowel disease: a recent update.Biomed Res Int.2013;2013:581631. doi:10.1155/2013/581631DailyMed.Label: Inflectra- infliximab-dyyb injection, powder, lyophilized, for solution.DailyMed.Label: Remicade- infliximab injection, powder, lyophilized, for solution.Abidin AZ, Snoswell CL, Shafiee Hanjani L, et al.Infliximab switching from reference product to biosimilar: a review of evidence regarding the clinical efficacy, safety profile and immunogenicity.Pharmacy Practice and Res.2021;51(5):358-373.Feagan BG, Lam G, Ma C, Lichtenstein GR.Systematic review: efficacy and safety of switching patients between reference and biosimilar infliximab.Aliment Pharmacol Ther. 2019;49(1):31-40. doi:10.1111/apt.14997
8 Sources
Verywell Health uses only high-quality sources, including peer-reviewed studies, to support the facts within our articles. Read oureditorial processto learn more about how we fact-check and keep our content accurate, reliable, and trustworthy.U.S Food and Drug Administration.What is a biosimilar?U.S Food and Administration.FDA approves Inflectra, a biosimilar to Remicade.MedlinePlus.Infliximab injection.Guo Y, Lu N, Bai A.Clinical use and mechanisms of infliximab treatment on inflammatory bowel disease: a recent update.Biomed Res Int.2013;2013:581631. doi:10.1155/2013/581631DailyMed.Label: Inflectra- infliximab-dyyb injection, powder, lyophilized, for solution.DailyMed.Label: Remicade- infliximab injection, powder, lyophilized, for solution.Abidin AZ, Snoswell CL, Shafiee Hanjani L, et al.Infliximab switching from reference product to biosimilar: a review of evidence regarding the clinical efficacy, safety profile and immunogenicity.Pharmacy Practice and Res.2021;51(5):358-373.Feagan BG, Lam G, Ma C, Lichtenstein GR.Systematic review: efficacy and safety of switching patients between reference and biosimilar infliximab.Aliment Pharmacol Ther. 2019;49(1):31-40. doi:10.1111/apt.14997
Verywell Health uses only high-quality sources, including peer-reviewed studies, to support the facts within our articles. Read oureditorial processto learn more about how we fact-check and keep our content accurate, reliable, and trustworthy.
U.S Food and Drug Administration.What is a biosimilar?U.S Food and Administration.FDA approves Inflectra, a biosimilar to Remicade.MedlinePlus.Infliximab injection.Guo Y, Lu N, Bai A.Clinical use and mechanisms of infliximab treatment on inflammatory bowel disease: a recent update.Biomed Res Int.2013;2013:581631. doi:10.1155/2013/581631DailyMed.Label: Inflectra- infliximab-dyyb injection, powder, lyophilized, for solution.DailyMed.Label: Remicade- infliximab injection, powder, lyophilized, for solution.Abidin AZ, Snoswell CL, Shafiee Hanjani L, et al.Infliximab switching from reference product to biosimilar: a review of evidence regarding the clinical efficacy, safety profile and immunogenicity.Pharmacy Practice and Res.2021;51(5):358-373.Feagan BG, Lam G, Ma C, Lichtenstein GR.Systematic review: efficacy and safety of switching patients between reference and biosimilar infliximab.Aliment Pharmacol Ther. 2019;49(1):31-40. doi:10.1111/apt.14997
U.S Food and Drug Administration.What is a biosimilar?
U.S Food and Administration.FDA approves Inflectra, a biosimilar to Remicade.
MedlinePlus.Infliximab injection.
Guo Y, Lu N, Bai A.Clinical use and mechanisms of infliximab treatment on inflammatory bowel disease: a recent update.Biomed Res Int.2013;2013:581631. doi:10.1155/2013/581631
DailyMed.Label: Inflectra- infliximab-dyyb injection, powder, lyophilized, for solution.
DailyMed.Label: Remicade- infliximab injection, powder, lyophilized, for solution.
Abidin AZ, Snoswell CL, Shafiee Hanjani L, et al.Infliximab switching from reference product to biosimilar: a review of evidence regarding the clinical efficacy, safety profile and immunogenicity.Pharmacy Practice and Res.2021;51(5):358-373.
Feagan BG, Lam G, Ma C, Lichtenstein GR.Systematic review: efficacy and safety of switching patients between reference and biosimilar infliximab.Aliment Pharmacol Ther. 2019;49(1):31-40. doi:10.1111/apt.14997
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