If you have been on Remicade (infliximab) for months or years and a letter from your plan says your next infusion will be Inflectra or Avsola, the first thought is usually that your treatment is being downgraded to save money. That reaction is reasonable. The change is driven by your plan's preferred-product policy, and as far as FDA-approved labeling goes, almost nothing about the infusion itself changes.
Prime Infusions administers Remicade, Inflectra, Renflexis, Avsola and unbranded infliximab at 13 infusion centers across New York and one in Atlanta, and has no infliximab product of its own to defend. For the medication itself, see our Remicade page.
Why Did My Insurance Switch My Remicade to a Biosimilar?
Health plans change infliximab products because of preferred-product policy, not because of anything about your case. UnitedHealthcare Commercial Medical Benefit Drug Policy 2026D0004AR, effective February 1, 2026, names Inflectra (infliximab-dyyb) and Avsola (infliximab-axxq) as preferred; to cover Remicade, Renflexis or another non-preferred infliximab it 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 adverse event to Inflectra or Avsola." Cigna Coverage Policy PSM005, effective August 15, 2026, lists "Avsola, Inflectra" as preferred and "infliximab (authorized generic), Remicade, Renflexis" as non-preferred, and directs the patient "to try at least one Preferred Product prior to the approval of a Non-Preferred Product."
Under both policies the original brand, Remicade, is the non-preferred one - the opposite of what most patients assume. Preferred lists change, so read the table below as two current examples, not as every plan.
| Infliximab product | UnitedHealthcare 2026D0004AR | Cigna PSM005 |
|---|---|---|
| Inflectra (infliximab-dyyb) | Preferred | Preferred |
| Avsola (infliximab-axxq) | Preferred | Preferred |
| Remicade (infliximab) | Non-preferred | Non-preferred |
| Renflexis (infliximab-abda) | Non-preferred | Non-preferred |
| Unbranded infliximab | "another non-preferred infliximab" | Non-preferred (authorized generic) |
What Is a Biosimilar, and What Does FDA Approval Actually Establish?
A biosimilar is a biologic licensed under section 351(k) of the Public Health Service Act. FDA's Biosimilar Basics for Patients describes one as "highly similar to a biologic medication already approved by FDA" - the original being the reference product. The biosimilar labels carry FDA's fuller formulation: approval rests on "data demonstrating that it is highly similar to an FDA-approved biological product, known as a reference product, and that there are no clinically meaningful differences" between the two. Remicade is the reference product, licensed under section 351(a), initial U.S. approval 1998.
The FDA Purple Book records Inflectra (BLA 125544, Celltrion) as approved April 5, 2016, Renflexis (BLA 761054, Samsung Bioepis) April 21, 2017, and Avsola (BLA 761086, Amgen) December 6, 2019.
That standard establishes a comparison against the reference product, not a ranking: an FDA biosimilar approval is not a finding that any infliximab product will perform better, worse or identically for you as an individual. Each biosimilar's approved indications are also set by its own labeling rather than copied from Remicade's, and our comparison of all five infliximab products goes through the labels side by side.
Is Any Infliximab Biosimilar Interchangeable With Remicade?
No. In the FDA Purple Book and FDA's list of licensed biosimilars, Inflectra, Renflexis and Avsola are each recorded as a "351(k) Biosimilar" with no interchangeability designation. FDA defines an interchangeable product as "a biosimilar that may be substituted without consulting the prescribing doctor, because it meets additional requirements related to the potential for automatic substitution," and notes that such substitution "is subject to state law." Interchangeability is a dispensing designation, not a claim that one product works better.
That matters in New York. N.Y. Education Law 6816-a lets a pharmacist substitute a biological product only where the substituted product is interchangeable with the prescribed one and the prescriber has not prohibited substitution, and it requires the pharmacist to name the product and manufacturer to the prescriber "within five business days." No infliximab product is interchangeable, so that pathway is unavailable for infliximab.
There is a second reason nobody can swap your infliximab quietly. Infliximab is provider-administered: CMS covers Part B drugs "provided as part of (or incident to) a physicians' service," billed under the medical benefit rather than dispensed at a pharmacy counter. The product in the bag is the one your prescriber ordered and the infusion center acquired, and moving from Remicade to Inflectra or Avsola takes a new prescriber order.
What Actually Changes at the Infusion Appointment?
By the labeling, nothing. The Remicade prescribing information, revised February 2025, sets induction at weeks 0, 2 and 6 followed by maintenance, dosed by weight in milligrams per kilogram. Adult and pediatric Crohn's disease, adult and pediatric ulcerative colitis, psoriatic arthritis and adult plaque psoriasis are dosed at 5 mg/kg every 8 weeks. Rheumatoid arthritis, indicated in combination with methotrexate, starts at 3 mg/kg. Ankylosing spondylitis is the one indication maintained every 6 weeks rather than every 8.
The administration instruction is unchanged. The label states that "The infusion must be administered intravenously for at least 2 hours" through an in-line, sterile, low-protein-binding filter with a pore size of 1.2 microns or less. Your weight is measured at each visit because dosing is weight-based, and Medicare billing guidance expects patient weight in the record. The label still directs that appropriate personnel and medication be available to treat reactions, and that the infusion be slowed or stopped if one occurs.
The safety information does not change either. Remicade, Inflectra, Renflexis and Avsola all carry the same boxed warning, WARNING: SERIOUS INFECTIONS and MALIGNANCY. It covers serious infections that may lead to hospitalization or death, including active tuberculosis, reactivation of latent tuberculosis and invasive fungal infections; testing for latent tuberculosis before infliximab is used and during therapy, with treatment of latent infection started first; lymphoma and other malignancies, some fatal, reported in children and adolescent patients treated with TNF blockers; and postmarketing cases of hepatosplenic T-cell lymphoma, an aggressive and fatal lymphoma reported mostly in adolescent and young adult males with Crohn's disease or ulcerative colitis who also received azathioprine or 6-mercaptopurine. No infliximab product carries a lesser warning than another.
What Genuinely Does Change When the Product Changes?
Four things, and none is the infusion. The first is the name: the vial reads Inflectra, Renflexis or Avsola, and the nonproprietary name carries a four-letter suffix - infliximab-dyyb, infliximab-abda, infliximab-axxq. One name is a trap. Unbranded infliximab is not a biosimilar; the version marketed by Janssen Biotech is unbranded Remicade, which Cigna PSM005 lists as "infliximab (authorized generic)."
The second is the billing code. The Medicare billing and coding article for infliximab and biosimilars (A52423) assigns product-specific HCPCS codes: J1745 for infliximab, Q5103 and Q5104 for biosimilars effective April 1, 2018, and Q5121 for infliximab-axxq effective July 1, 2020. The billing unit is 10 mg, so the same dose is submitted under a different code.
The third is the authorization. Because a prior authorization is issued against a specific product and code, a product change usually means a new request rather than an amendment. Prime Infusions submits these with your prescribing physician; the plan makes the determination. Our article on infliximab prior authorization and appeals covers what goes into it.
The fourth is manufacturer copay assistance, where patients are most often caught out. These programs are run by manufacturers, not by your plan or infusion center, and each is tied to one product. Remicade is a Janssen Biotech product; Inflectra, Renflexis and Avsola have different manufacturers, so enrollment does not carry over. Ask the new manufacturer whether it runs a program you qualify for.
What Should I Ask My Prescriber and My Health Plan?
Ask questions with specific answers. The prescriber controls the order, the plan controls coverage, and the infusion center administers what the order says.
- Which product is on the new order - brand name and full nonproprietary name with suffix?
- Does my dose in mg/kg and my interval stay the same?
- Has a new prior authorization been approved on the new product's code, and through what date?
- Which written policy is my plan applying? Ask for its number and effective date.
- If I have a documented intolerance or adverse event to a preferred product, what documentation does my plan need?
- Does the new product's manufacturer run a copay assistance program?
- Who do I call between infusions if I have a reaction or my symptoms change?
Whether to accept the change, request an exception or appeal is a decision for you and your prescriber; Prime Infusions administers what the prescriber orders and does not steer patients toward any infliximab product.
Where Can I Continue Infliximab Infusions in New York?
Prime Infusions administers all five infliximab products at 13 New York infusion centers and one in Atlanta, including the Brooklyn infusion center on Foster Avenue, the Manhattan infusion center on the Upper East Side and the Great Neck infusion center. If your plan has changed your infliximab product, Prime Infusions verifies benefits and submits the authorization request; the plan makes the determination. Patients can start with the Remicade and infliximab request form, and referring physicians can use the referrals page or call 718-443-4000. Dosing and safety details are on the Remicade at Prime Infusions 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.