Five infliximab products can arrive at an infusion chair in New York: Remicade, Inflectra, Renflexis, Avsola and unbranded infliximab. Prime Infusions administers all five and so has no product of its own to defend here. What follows is what the FDA Purple Book, the labels, CMS billing guidance and two named payer policies say about how the five differ, and where they do not.
What infliximab products are approved in the United States?
Remicade is the reference product: infliximab, BLA 103772, from Janssen Biotech, initial U.S. approval 1998, per the Remicade prescribing information (rev. 2/2025). Three biosimilars are licensed under section 351(k) of the Public Health Service Act: Inflectra (infliximab-dyyb), Renflexis (infliximab-abda) and Avsola (infliximab-axxq). Unbranded infliximab, the fifth product, is not a biosimilar at all: it is Remicade sold without the Remicade name. The table sets out the FDA Purple Book record and label data for each.
| Product | What it is | Nonproprietary name | BLA | Applicant | FDA approval | Interchangeability |
|---|---|---|---|---|---|---|
| Remicade | Reference product, licensed under section 351(a) | infliximab | 103772 | Janssen Biotech | 1998 (initial U.S. approval) | Not applicable - Remicade is the reference product |
| Inflectra | 351(k) biosimilar to Remicade | infliximab-dyyb | 125544 | Celltrion, Inc. | April 5, 2016 | Listed as "351(k) Biosimilar" - not interchangeable |
| Renflexis | 351(k) biosimilar to Remicade | infliximab-abda | 761054 | Samsung Bioepis Co., Ltd. | April 21, 2017 | Listed as "351(k) Biosimilar" - not interchangeable |
| Avsola | 351(k) biosimilar to Remicade | infliximab-axxq | 761086 | Amgen Inc. | December 6, 2019 | Listed as "351(k) Biosimilar" - not interchangeable |
| Unbranded infliximab | Unbranded version of the reference product, not a biosimilar | infliximab | 103772 (same BLA as Remicade) | Janssen Biotech | Same license as Remicade | Not applicable - no biosimilarity or interchangeability designation |
All five products carry the same eight FDA-approved indications - adult and pediatric (6 years and older) Crohn's disease, adult and pediatric (6 years and older) ulcerative colitis, rheumatoid arthritis in combination with methotrexate, ankylosing spondylitis, psoriatic arthritis and adult chronic severe plaque psoriasis - in the same populations, per each product's own section 1. That is not automatic: a biosimilar can be approved for fewer indications than its reference product, and pediatric ulcerative colitis in particular was once carved out of infliximab biosimilar labels. It is present in all of them as currently labeled. Full indication text, dosing tables and the complete boxed warning for each product sit on the Prime Infusions pages for Remicade, Inflectra, Renflexis, Avsola and unbranded infliximab.
Is unbranded infliximab a biosimilar?
No. The unbranded infliximab marketed by Johnson & Johnson and Janssen Biotech is an unbranded version of Remicade itself, under the same BLA 103772. Three details confirm it: the nonproprietary name is plain "infliximab" with none of the four-letter suffixes FDA assigns to biosimilars, the DailyMed label for unbranded infliximab is listed under Janssen Biotech, and that label carries no biosimilarity statement. Cigna refers to it as "infliximab (authorized generic)" in its coverage policy.
This is the most confused point in the category, and it matters: a patient moved to unbranded infliximab has not been switched to a biosimilar. One caution: the phrase can also describe an unbranded biosimilar presentation, so the product named on the prescriber's order settles it.
How does Avsola compare with Remicade?
Avsola is infliximab-axxq, BLA 761086, from Amgen Inc., approved December 6, 2019 and listed in the FDA Purple Book as a "351(k) Biosimilar" with no interchangeability designation. The standard behind that listing is stated in the Avsola labeling: a biosimilar is approved on data showing it is "highly similar" to the reference product with "no clinically meaningful differences" from it. Remicade, by contrast, is the reference product licensed under section 351(a).
Avsola bills under its own Medicare HCPCS code, Q5121, effective July 1, 2020, while infliximab bills under J1745, per the CMS contractor article Billing and Coding: Infliximab and biosimilars (A52423). The dosing schedule, the weight-based calculation, the minimum two-hour infusion and the boxed warning are the same for Avsola as for Remicade. Prime Infusions administers both and recommends neither; that choice belongs to the prescriber and the plan.
How does Renflexis compare with Remicade?
Renflexis is infliximab-abda, BLA 761054, from Samsung Bioepis Co., Ltd., approved April 21, 2017 and listed in the FDA Purple Book as a "351(k) Biosimilar" - again with no interchangeability designation. Renflexis met the same 351(k) standard as the other infliximab biosimilars: highly similar to Remicade, with no clinically meaningful differences from it.
Where Renflexis sits differently from Avsola and Inflectra is on payer formularies, not on the FDA record. Both policies described below place Renflexis outside their preferred infliximab products, in the same position as Remicade. That is a formulary classification, not a statement about how Renflexis performs. For a patient established on Renflexis, it is why a plan change can trigger a coverage review when nothing clinical has changed - the scenario covered in what changes when insurance switches you to a biosimilar.
Can a pharmacist substitute one infliximab product for another?
No, and three facts stack up to that answer. First, no infliximab product carries an FDA interchangeability designation - all three biosimilars are listed only as "351(k) Biosimilar." FDA defines an interchangeable product as one that "may be substituted without consulting the prescribing doctor," and notes on its Biosimilar Basics for Patients page that such substitution is subject to state law. Second, New York's statute is gated on that designation: N.Y. Education Law section 6816-a allows substitution only where the substituted product "is either an interchangeable biological product for the prescribed product or the substituted biological product is one for which the prescribed product is an interchangeable biological product." No interchangeable infliximab exists, so that pathway is unavailable.
Third, infliximab is provider-administered: CMS covers infliximab under Medicare Part B as a drug furnished incident to a physician's service, not dispensed at a retail counter, so no pharmacy substitution step exists. Moving between Remicade, Inflectra, Renflexis, Avsola or unbranded infliximab therefore requires a new prescriber order, and usually a new prior authorization.
Which infliximab product will my health plan cover?
For two national payers the answer is written down. UnitedHealthcare Commercial Medical Benefit Drug Policy 2026D0004AR, effective February 1, 2026, designates Inflectra and Avsola as the preferred infliximab products. To obtain Remicade or Renflexis, UnitedHealthcare requires "Documentation of a trial of at least 14 weeks of Inflectra or Avsola resulting in minimal clinical response to therapy and residual disease activity," or documentation of intolerance, contraindication or an adverse event with Inflectra or Avsola. Cigna Coverage Policy PSM005, effective August 15, 2026, lists its preferred products as "Avsola, Inflectra" and its non-preferred products as "infliximab (authorized generic), Remicade, Renflexis," and directs the patient to try at least one preferred product before a non-preferred product is approved.
Under both policies the originator, Remicade, is non-preferred, and so is Renflexis. "Preferred" and "non-preferred" are the payers' own formulary terms; neither policy ranks the products clinically. Preferred lists change, which is why policy numbers and effective dates belong beside such statements. Coverage is determined by each patient's plan; Prime Infusions verifies benefits and submits the authorization request, and the plan decides. Where a request is denied, the appeal route is set out in infliximab prior authorization denials and appeals.
What is the same across all five infliximab products, and what is not?
The infusion itself is the same across Remicade, Inflectra, Renflexis, Avsola and unbranded infliximab. Dosing is weight-based in mg/kg, with induction at weeks 0, 2 and 6, then maintenance every 8 weeks for Crohn's disease, ulcerative colitis, psoriatic arthritis and plaque psoriasis; rheumatoid arthritis starts at 3 mg/kg rather than 5 mg/kg and is labeled in combination with methotrexate, and ankylosing spondylitis maintains every 6 weeks. The Remicade label states the infusion "must be administered intravenously for at least 2 hours" through an in-line, low-protein-binding filter - a floor set by FDA labeling, not by clinic scheduling.
The safety warning is also the same. Every infliximab product carries the boxed warning headed WARNING: SERIOUS INFECTIONS and MALIGNANCY: increased risk of serious infections leading to hospitalization or death, including active tuberculosis and reactivation of latent tuberculosis, invasive fungal infections such as histoplasmosis and coccidioidomycosis, and other opportunistic infections; testing for latent tuberculosis before starting therapy and during therapy, with treatment of latent infection started before therapy begins; lymphoma and other malignancies, some fatal, reported in children and adolescents treated with TNF blockers; and postmarketing cases of hepatosplenic T-cell lymphoma, an aggressive and fatal lymphoma, mostly in adolescent and young adult males with Crohn's disease or ulcerative colitis who also received azathioprine or 6-mercaptopurine.
What is not automatically identical is the indication list, set by each product's own labeling rather than inherited from the reference product. The Remicade label carries eight indications: Crohn's disease in adults and in patients 6 years and older, ulcerative colitis in adults and in patients 6 years and older, rheumatoid arthritis with methotrexate, ankylosing spondylitis, psoriatic arthritis, and chronic severe plaque psoriasis in adults. Hidradenitis suppurativa, uveitis, sarcoidosis, Behcet's disease and graft-versus-host disease are off-label for every infliximab product.
How do I start or move infliximab infusions to Prime Infusions?
Prime Infusions administers all five infliximab products at 13 infusion centers in New York and one in Atlanta, including the Brooklyn infusion center on Foster Avenue, the Upper East Side center in Manhattan and the Great Neck center in Nassau County. Patients and caregivers can start with the infliximab request form; referring physicians can use the Prime Infusions referrals page or call 718-443-4000. Send the prescriber's order naming the specific product: the product name, not the drug class, drives the benefit check and the authorization request. Background on the therapy sits on the Remicade and infliximab page.
This article is for general education and is not medical advice, a diagnosis, or a treatment recommendation. Every infliximab product carries an FDA boxed warning headed "WARNING: SERIOUS INFECTIONS and MALIGNANCY", covering serious infections including tuberculosis and invasive fungal infection, and malignancy including lymphoma and hepatosplenic T-cell lymphoma; review the full prescribing information for the product prescribed to you and discuss your individual risk factors with your treating clinician. Coverage and out-of-pocket cost are determined by your health plan.