Inflectra (infliximab-dyyb) Infusion Therapy in New York

Inflectra (infliximab-dyyb) is a tumor necrosis factor (TNF) blocker given by intravenous infusion. It is a biosimilar to Remicade (infliximab) — and in FDA's terms, a biosimilar is not a generic.

FDA's patient-facing explanation is that "a biosimilar is a biologic medication. It is highly similar to a biologic medication already approved by FDA – the original biologic (also called the reference product)." The biosimilar labels themselves carry FDA's fuller formulation: the product "is approved based 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 biosimilar product] and the reference product." Remicade is the reference product, licensed under section 351(a) of the Public Health Service Act with an initial U.S. approval of 1998. Inflectra is licensed under section 351(k).

The word that does the work most people expect "generic" to do is interchangeable. 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, depending on state law, "a pharmacist may give you an interchangeable biosimilar, much like they would give you a generic." Inflectra does not carry that designation. In the FDA Purple Book, Inflectra (BLA 125544, Celltrion, Inc., approved April 5, 2016) is listed as "351(k) Biosimilar," and FDA's biosimilar product list shows no interchangeability designation for any infliximab product — not Inflectra, and not any of the others.

FDA is explicit that interchangeability is a designation about whether a pharmacist may substitute without consulting the prescriber, subject to state law. It is not a statement that one product works better than another. Prime Infusions does not recommend any infliximab product over another.

In practice it means your health plan has designated Inflectra a "preferred product" under its own medical-benefit policy, and that staying on Remicade would now have to be justified to the plan. Most patients assume the originator is the default. Under two large national commercial policies it is not: Remicade is the non-preferred product and Inflectra is one of the two preferred ones.

UnitedHealthcare — Commercial Medical Benefit Drug Policy "Infliximab (Avsola, Inflectra, Remicade & Renflexis)," Policy 2026D0004AR, effective February 1, 2026 — names Inflectra (infliximab-dyyb) and Avsola (infliximab-axxq) as its preferred products. To cover Remicade, Renflexis or another non-preferred infliximab, the policy asks for "documentation of a trial of at least 14 weeks of Inflectra or Avsola resulting in minimal clinical response to therapy and residual disease activity," together with a prescriber attestation, or "documentation of intolerance, contraindication, or adverse event to Inflectra or Avsola."

Cigna — "Infliximab Intravenous Products Preferred Specialty Management Policy," Coverage Policy PSM005, effective 08/15/2026 — 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."

What the change is, factually. Inflectra was licensed under section 351(k) on data demonstrating it is highly similar to Remicade, with no clinically meaningful differences between the two. That is the standard FDA applied to approve it. It is not a statement by Prime Infusions about what either product will do for you, and this page does not rank the two against each other in either direction. Inflectra's labeling carries the same boxed warning as the reference product, headed "WARNING: SERIOUS INFECTIONS and MALIGNANCY," so the tuberculosis screening and infection monitoring set out below apply either way.

What does not change is who decides. Infliximab is provider-administered under the medical benefit, not dispensed at a retail counter, so there is no pharmacy substitution step in the workflow. New York's substitution statute, Education Law § 6816-a, is gated on FDA interchangeability, and because no infliximab product carries that designation, the statute's substitution pathway does not apply to infliximab at all. The product you receive is the one your prescriber orders, interacting with your plan's policy. Questions about the change belong with that prescriber and with the plan. Preferred-product lists also change, so the policy numbers and effective dates above are worth re-checking rather than assumed.

Inflectra is FDA-approved for all eight infliximab indications carried by its reference product — no omissions, no narrower populations, no added age limits. That is read directly from section 1 of Inflectra's own FDA-approved prescribing information on DailyMed (Pfizer Laboratories, revised 9/2025), not inferred from the Remicade label. The distinction is worth stating, because a biosimilar's approved indications are set by its own labeling and a biosimilar does not automatically carry every indication its reference product carries. Inflectra carries all eight. The table below is Inflectra's section 1 as printed.

Two details are easy to get wrong. Rheumatoid arthritis is a combination indication — the labeled indication is in combination with methotrexate, not as monotherapy. And the only pediatric indications are Crohn's disease and ulcerative colitis, in patients 6 years of age and older. Ankylosing spondylitis, psoriatic arthritis and plaque psoriasis are adult-only, and there is no pediatric rheumatoid arthritis indication.

Infliximab given to a child for a condition other than Crohn's disease or ulcerative colitis, or given for any condition outside these eight — hidradenitis suppurativa, uveitis, sarcoidosis, Behcet's disease, pyoderma gangrenosum, graft-versus-host disease — is off-label, meaning it is not an FDA-approved use of the product. That is a decision for the treating clinician to make and to explain.

One formulation note: everything on this page concerns intravenous infliximab. Subcutaneous infliximab is a separate product with its own labeling, dispensed under the pharmacy benefit rather than administered in an infusion suite.

Inflectra is given as an intravenous infusion in a clinical setting, and the dose is weight-based in mg/kg, which is why your weight is measured at each visit. Every indication uses the same induction schedule — weeks 0, 2 and 6 — followed by a maintenance interval, and the infusion itself takes a labeled minimum of two hours. The schedule below is the labeled dosing for intravenous infliximab, from the REMICADE prescribing information (rev. 2/2025); the dose and interval that apply to you are the ones in your prescriber's order and in the labeling for the product prescribed.

Two things people misremember: rheumatoid arthritis starts at 3 mg/kg, the only indication that does not start at 5, and ankylosing spondylitis maintains every 6 weeks, the only indication that is not every 8.

The two-hour minimum is not a scheduling convention. The label instructs that "the infusion must be administered intravenously for at least 2 hours with an infusion set with an in-line, sterile, non-pyrogenic, low-protein-binding filter (pore size of 1.2 µm or less)." The current US labeling sets out no shortened or one-hour infusion option, for the reference product or for its biosimilars. Your visit runs longer than the infusion, because it also takes in check-in and weight, vascular access and pre-infusion assessment, preparation of the drug, and any premedication your prescriber has ordered. Premedication is permissive in the label rather than required — patients "may be premedicated with histamine-1 receptor antagonists, histamine-2 receptor antagonists, acetaminophen, and/or corticosteroids" — so it is the prescriber's decision, not something given as a matter of routine.

The label also directs that, prior to treatment, clinicians "ensure appropriate personnel and medication are available to treat reactions (e.g., hypersensitivity, other reactions) that occur during infusion and shortly after infusion," that "for mild to moderate reactions during the infusion, consider slowing or stopping the infusion," and that patients be monitored during infusion, with the infusion discontinued if a serious reaction occurs.

Inflectra's FDA-approved labeling carries a boxed warning — the most serious warning FDA requires on a prescription label — headed "WARNING: SERIOUS INFECTIONS and MALIGNANCY." The same warning appears on the reference product and on the infliximab biosimilars, with the product name substituted; no infliximab product carries a lesser warning. The text quoted below is from the REMICADE prescribing information (rev. 2/2025).

Serious infections

Patients treated with REMICADE "are at increased risk for developing serious infections that may lead to hospitalization or death," and "most patients who developed these infections were taking concomitant immunosuppressants such as methotrexate or corticosteroids." Treatment "should be discontinued if a patient develops a serious infection or sepsis."

Reported infections include active tuberculosis, including reactivation of latent tuberculosis. Patients with tuberculosis "have frequently presented with disseminated or extrapulmonary disease." The labeled requirement has two halves and both matter: patients "should be tested for latent tuberculosis before" infliximab use "and during therapy," and "treatment for latent infection should be initiated prior to" starting. Reported infections also include invasive fungal infections — "histoplasmosis, coccidioidomycosis, candidiasis, aspergillosis, blastomycosis, and pneumocystosis" — which "may present with disseminated, rather than localized, disease," and for which "antigen and antibody testing for histoplasmosis may be negative in some patients with active infection"; empiric anti-fungal therapy "should be considered in patients at risk for invasive fungal infections who develop severe systemic illness." Also reported are "bacterial, viral and other infections due to opportunistic pathogens, including Legionella and Listeria."

The label directs that the risks and benefits of treatment "should be carefully considered prior to initiating therapy in patients with chronic or recurrent infection," and that patients "should be closely monitored for the development of signs and symptoms of infection during and after treatment," including "the possible development of tuberculosis in patients who tested negative for latent tuberculosis infection prior to initiating therapy."

Malignancy

"Lymphoma and other malignancies, some fatal, have been reported in children and adolescent patients treated with TNF blockers," infliximab included.

"Postmarketing cases of hepatosplenic T-cell lymphoma (HSTCL), a rare type of T-cell lymphoma, have been reported in patients treated with TNF blockers." These cases "have had a very aggressive disease course and have been fatal." "Almost all patients had received treatment with azathioprine or 6-mercaptopurine concomitantly with a TNF blocker at or prior to diagnosis," and the majority of reported cases "have occurred in patients with Crohn's disease or ulcerative colitis and most were in adolescent and young adult males."

None of this is a reason to change or stop a prescribed treatment on your own. It is the reason infliximab is prescribed and monitored by a clinician, the reason tuberculosis testing happens before the first infusion and continues during therapy, and the reason new fever, cough, night sweats, unexplained weight loss or persistent swollen glands should be reported to your prescriber promptly rather than saved for the next visit.

The figures below come from the reference product's own clinical trial table — adverse reactions reported in at least 5% of patients who received four or more infusions in rheumatoid arthritis trials, REMICADE prescribing information, section 6.1. As the label itself frames it, clinical trial rates are observed under widely varying conditions and cannot be directly compared with rates in other trials or with rates seen in practice. These are adult RA trial figures; pediatric rates are reported separately in the labeling and should not be assumed to match them.

Infusion reactions. "Approximately 20% of REMICADE-treated patients experienced an infusion reaction compared with 10% of placebo-treated patients." Reactions occur during an infusion or within about an hour after it. Across all infusions, "3% were accompanied by nonspecific symptoms such as fever or chills, 1% were accompanied by cardiopulmonary reactions (primarily chest pain, hypotension, hypertension or dyspnea), and <1% were accompanied by pruritus, urticaria." And: "Serious infusion reactions occurred in <1% of patients and included anaphylaxis, convulsions, erythematous rash and hypotension."

That is the honest shape of it. Roughly one patient in five has some infusion reaction; most are mild to moderate, and the label's own instruction for those is to consider slowing or stopping the infusion. Serious reactions occur in fewer than 1% of patients, but they include anaphylaxis — which is exactly why the label requires appropriate personnel and emergency medication to be available before treatment starts, and why you are monitored during the infusion and afterwards. Tell your nurse straight away about itching, hives, flushing, chest tightness, shortness of breath, fever or chills, rather than waiting to see whether it passes.

Prime Infusions has 13 infusion centers in New York, plus one in Atlanta. In New York City and the surrounding counties that means Brooklyn (Foster Avenue) and Boro Park in Brooklyn; Fresh Meadows, Astoria, Jamaica and Howard Beach in Queens; the Upper East Side in Manhattan; Staten Island; Great Neck in Nassau County and Inwood in the Five Towns; Port Jefferson Station in Suffolk County; and New City in Rockland County and Monroe in Orange County. All centers are open Monday to Friday, 9:00AM to 5:00PM, and addresses are on our locations page. Because maintenance runs on a fixed 6- or 8-week interval for years, the practical question is usually which center you can reach reliably on a weekday. Our care team confirms which location will administer your infusions — per-center product availability is not published, so it is worth asking before the first appointment is booked.

What your plan reviews. Commercial plans apply diagnosis-specific criteria before authorizing infliximab, on top of the preferred-product rules described above. Medicare covers infliximab under Part B rather than Part D, because it is administered by a clinician: CMS covers "drugs provided as part of (or incident to) a physicians' service" and states that "generally, Part B covers only drugs that are not usually self-administered." The Medicare contractor billing and coding article for infliximab and biosimilars (Article A52423, revision effective 04/01/2026) expects the record to document the basis for the diagnosis, the patient's weight, that tuberculosis evaluation and treatment were initiated before therapy, and an inadequate response to a 3-month trial of conventional non-biologic therapy. Product-specific HCPCS codes apply, and the dosage associated with the code is 10 mg.

Site of care. UnitedHealthcare's "Provider Administered Drugs – Site of Care" policy 2026D0121V, effective August 1, 2026, lists Inflectra expressly within scope and states that "Alternative Sites of Care, such as non-hospital outpatient infusion, physician office, ambulatory infusion suites, or home infusion services are well accepted places of service for medication infusion therapy," and that if an individual does not meet criteria for outpatient hospital facility infusion, alternative sites of care may be used. Whether that applies to a particular patient is a determination only that patient's plan can make.

Coverage, prior authorization requirements and out-of-pocket cost are determined solely by your health plan. Our team verifies benefits and submits the authorization request; we cannot guarantee approval. Physicians can send a referral through our Treatment Referrals directory. Patients and families can reach us at 718-443-4000 or through our contact page.