Inflectra (infliximab-dyyb) — FDA-Approved Biosimilar to Remicade (infliximab)

TNF-alpha Inhibitor Biosimilar (IV) · Approved 2016 · $0–$35/mo for most insured patients

🔬 What Is Inflectra?

Inflectra (infliximab-dyyb) is an FDA-approved biosimilar to Remicade (infliximab). A biosimilar is a biological medication that is highly similar to an already-approved reference biologic, with no clinically meaningful differences in safety, purity, or potency. Inflectra (infliximab-dyyb) was the first FDA-approved Remicade biosimilar, approved in 2016. It is manufactured by Celltrion and distributed by Pfizer in the US. Given by IV infusion, it is approved for all Remicade indications with the same dosing schedule.

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With Insurance

$0–$35/mo for most insured patients

Pfizer RxPathways

Uninsured / PAP

Free

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Inflectra Overview

PropertyDetails
Brand NameInflectra
Generic Nameinfliximab-dyyb
Reference BiologicRemicade (infliximab)
ManufacturerPfizer/Celltrion
Drug ClassTNF-alpha Inhibitor Biosimilar (IV)
FDA Approval2016
RouteIV infusion
Approved ConditionsRheumatoid Arthritis, Ankylosing Spondylitis, Psoriatic Arthritis, Plaque Psoriasis, Crohn's Disease, Ulcerative Colitis
Copay ProgramPfizer RxPathways — $0–$35/mo for most insured patients

Approved Conditions

Rheumatoid ArthritisAnkylosing SpondylitisPsoriatic ArthritisPlaque PsoriasisCrohn's DiseaseUlcerative Colitis

Inflectra vs Remicade (infliximab)

Inflectra has been demonstrated to be biosimilar to Remicade (infliximab) through comprehensive analytical, non-clinical, and clinical studies. The FDA requires that biosimilars have no clinically meaningful differences from the reference product. Patients who are stable on Remicade (infliximab) should discuss any potential switch to Inflectra with their prescriber.

FactorInflectraRemicade (infliximab)
FDA StatusBiosimilar (approved 2016)Reference biologic
Active Ingredientinfliximab-dyybinfliximab
MechanismTNF-alpha Inhibitor)Same
Approved IndicationsSame as Remicade (infliximab)Multiple FDA-approved
Typical Patient Cost$0–$35/mo for most insured patients$0–$35/mo (varies by plan)
Yes. The FDA requires biosimilars to demonstrate there are no clinically meaningful differences in safety, purity, and potency compared to the reference product. Inflectra underwent rigorous clinical studies demonstrating biosimilarity to Remicade (infliximab). Your prescriber can discuss whether Inflectra is appropriate for your specific situation.
Many patients do switch from reference biologics to biosimilars. The decision should be made in consultation with your prescriber. Switching is generally safe for stable patients, but your doctor may want to monitor you during the transition. BiologicHealthPlus can coordinate the prior authorization for Inflectra and ensure a seamless supply transition.
Most commercial insurance plans and Medicare Part D cover Inflectra with prior authorization. In many cases, Inflectra may have a lower tier placement on formularies than Remicade (infliximab), potentially reducing your copay. BiologicHealthPlus verifies your insurance coverage, handles all prior authorization, and enrolls you in the Pfizer RxPathways copay program to minimize your out-of-pocket costs.
Without insurance, Inflectra costs approximately $4900/month at list price — lower than Remicade (infliximab)'s list price. Uninsured or underinsured patients may qualify for patient assistance through Pfizer RxPathways. BiologicHealthPlus will find every available savings option for you at no charge.

📚 Sources & Further Reading

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FDA Biosimilar ApprovalsFDA
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BiosimilarWikipedia
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ACR Biosimilar PositionACR
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Biosimilar DevelopmentNIH/NCBI
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Medicare Biosimilar CoverageCMS

Medical Disclaimer: Educational content reviewed by BiologicHealthPlus Clinical Team. Last reviewed: August 2026.

Medical Disclaimer: This page is for informational purposes only. Inflectra requires a valid prescription. Consult your physician before making any changes to your medication. Last updated: August 2026.