Renflexis (infliximab-abda) Infusion Therapy in New York

Renflexis (infliximab-abda) is a biosimilar to Remicade — not a generic. FDA licensed it under BLA 761054 to Samsung Bioepis Co., Ltd. on April 21, 2017, and the FDA Purple Book records its evaluation as "351(k) Biosimilar." Remicade is the reference product, licensed under section 351(a) of the Public Health Service Act, initial U.S. approval 1998.

"Generic" and "biosimilar" are different regulatory categories, and the difference is not cosmetic. A generic is an identical copy of a small chemical molecule. A biologic like infliximab is a large protein produced in living cells, and an exact copy is not achievable, so FDA created a separate approval pathway. In FDA's own patient-facing words, "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 Renflexis prescribing information carries FDA's fuller formulation in its Highlights: biosimilar "means that the biological 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."

Renflexis does not carry an FDA interchangeability designation, and neither does any other infliximab product. In the Purple Book and on FDA's biosimilar product list, every infliximab biosimilar — Inflectra (infliximab-dyyb), Renflexis (infliximab-abda) and Avsola (infliximab-axxq) — appears as a 351(k) biosimilar with no interchangeability notation. FDA describes 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 substitution "is subject to state law." Interchangeability is a dispensing designation, not a statement that a product works better.

The short answer: what changes is the product label on the bag, the manufacturer, and the billing and authorization paperwork behind it. What does not change is how the drug is given. Renflexis and Remicade are both intravenous infliximab, both dosed by body weight in mg/kg, both given on the same weeks 0, 2 and 6 induction schedule, both infused over a labeled minimum of two hours, and both carry the same boxed warning and the same requirement to test for latent tuberculosis before and during therapy. A switch is a product decision made by your prescriber and your health plan, not something that happens at a pharmacy counter without anyone telling you.

What changes

• The brand and the manufacturer — Renflexis is made by Samsung Bioepis; Remicade by Janssen Biotech. The nonproprietary name carries the four-letter suffix that identifies the product: infliximab-abda.
• The billing code. Medicare's contractor billing article for infliximab and biosimilars (Article A52423) assigns product-specific HCPCS codes — J1745 for infliximab, and separate Q-codes for the biosimilars. A change of product means the claim is filed under a different code.
• The prior authorization. Because an authorization is tied to a specific product, a switch generally means a new request has to be on file with your plan before the first infusion of the new product.
• Which product your infusion center stocks and orders for your appointments.

What does not change, by the labeling

• Intravenous administration in an infusion suite — both products are provider-administered, not self-injected at home.
• Weight-based mg/kg dosing, with your weight recorded at each visit.
• The induction schedule at weeks 0, 2 and 6, then maintenance every 8 weeks for most indications and every 6 weeks for ankylosing spondylitis.
• The labeled instruction that the infusion run "for at least 2 hours" through an in-line, low-protein-binding filter.
• The boxed warning, WARNING: SERIOUS INFECTIONS and MALIGNANCY, which appears on the biosimilar labels with the product name substituted.
• Latent tuberculosis testing before starting and during therapy, and monitoring during and shortly after each infusion with trained personnel and emergency medication on hand.

Prime Infusions does not recommend one infliximab product over another and does not tell patients which one to ask for. FDA's 351(k) standard is a statement about the approval data, not a promise about any individual's course of treatment. If you have questions about a switch — why it was made, or whether it is right for you — that conversation belongs with the prescriber who writes the order and with the plan that sets the coverage rule.

Yes — Renflexis is FDA-approved for all eight infliximab indications carried by its reference product, in the same populations, including ulcerative colitis in patients 6 years of age and older. That is read from section 1 of the Renflexis prescribing information on DailyMed (Organon LLC, revised 10/2025), not from the Remicade label. The question is a fair one to ask, because approved indications are set product by product and a biosimilar's indication list can be narrower than its reference product's. Renflexis's is not narrower. Your prescriber and our clinical team still check the label that applies to the specific order.

The pediatric indications stop at Crohn's disease and ulcerative colitis, age 6 and older. There is no pediatric indication for rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis or plaque psoriasis. Use in a child for one of those conditions, and any use outside the eight indications above — hidradenitis suppurativa, uveitis, sarcoidosis, Behcet's disease, pyoderma gangrenosum, graft-versus-host disease — is off-label, meaning FDA has not approved the product for that use.

One formulation note that causes confusion: 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. The two are not interchangeable descriptions of the same treatment.

Renflexis is given as an intravenous infusion, dosed by body weight, on a fixed schedule: an induction series at weeks 0, 2 and 6, then maintenance at a set interval. By the labeling, the infusion itself runs a minimum of two hours. Most indications use 5 mg/kg; rheumatoid arthritis is the exception at 3 mg/kg, and it is dosed in combination with methotrexate.

Two details are easy to get wrong: rheumatoid arthritis starts at 3 mg/kg, not 5, and ankylosing spondylitis maintains every 6 weeks, not 8. The label also describes escalation options a prescriber may consider — in adult Crohn's disease, "consideration may be given to treatment with 10 mg/kg" for patients who respond and then lose response; in rheumatoid arthritis with incomplete response, "up to 10 mg/kg every 8 weeks or treating as often as every 4 weeks."

Your total visit is longer than the infusion. The two-hour minimum is the FDA-approved administration instruction, not a scheduling convention. On top of it, an appointment includes check-in and a weight measurement (dosing is mg/kg, and Medicare billing guidance expects the weight in the record), vascular access and pre-infusion assessment, reconstitution and dilution of the drug, any premedication the prescriber has ordered, and monitoring before you are discharged. The label treats premedication permissively, not as a requirement: patients "may be premedicated with histamine-1 receptor antagonists, histamine-2 receptor antagonists, acetaminophen, and/or corticosteroids." Whether you receive any is your prescriber's decision.

The Renflexis label carries a boxed warning — FDA's most serious warning — headed "WARNING: SERIOUS INFECTIONS and MALIGNANCY." It is the same boxed warning that appears on the Remicade reference label with the product name substituted, and it is the reason infliximab therapy is preceded by tuberculosis screening and supervised in a clinical setting. It is reproduced here in substance; read it in full in the product's prescribing information and discuss it with your prescriber.

Serious infections

Patients treated with infliximab "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." Patients should be tested for latent tuberculosis before use and during therapy, and treatment for latent infection should be initiated prior to use. Both halves of that requirement are in the warning.
• Invasive fungal infections, including histoplasmosis, coccidioidomycosis, candidiasis, aspergillosis, blastomycosis and pneumocystosis. Patients "may present with disseminated, rather than localized, disease," antigen and antibody testing for histoplasmosis "may be negative in some patients with active infection," and empiric anti-fungal therapy should be considered in at-risk patients who develop severe systemic illness.
• Bacterial, viral and other infections due to opportunistic pathogens, including Legionella and Listeria.

The risks and benefits of treatment "should be carefully considered prior to initiating therapy in patients with chronic or recurrent infection." 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," including infliximab. Postmarketing cases of hepatosplenic T-cell lymphoma (HSTCL), a rare type of T-cell lymphoma, "have been reported in patients treated with TNF blockers." The warning states that "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 occurred in patients with Crohn's disease or ulcerative colitis, most of them adolescent and young adult males.

Common side effects reported in the label's trials

In the reference product's rheumatoid arthritis trial table — adverse reactions in at least 5% of patients receiving four or more infusions, infliximab (n=1129) versus placebo (n=350) — the most frequently reported were upper respiratory tract infection (32% vs 25%), nausea (21% vs 20%), headache (18% vs 14%), sinusitis (14% vs 8%), diarrhea (12% vs 12%), abdominal pain (12% vs 8%), pharyngitis (12% vs 8%), coughing (12% vs 8%), bronchitis (10% vs 9%), rash (10% vs 5%), dyspepsia (10% vs 7%), fatigue (9% vs 7%), urinary tract infection (8% vs 6%), pain (8% vs 7%), arthralgia (8% vs 7%), pruritus (7% vs 2%), fever (7% vs 4%), hypertension (7% vs 5%) and moniliasis (5% vs 3%). As the label itself notes, 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 rheumatoid arthritis trial figures; pediatric rates should not be assumed to match them.

Infusion reactions

The label reports that "approximately 20% of REMICADE-treated patients experienced an infusion reaction compared with 10% of placebo-treated patients," with reactions occurring during an infusion or within one 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." "Serious infusion reactions occurred in <1% of patients and included anaphylaxis, convulsions, erythematous rash and hypotension." That is why the label instructs that prior to treatment clinicians "ensure appropriate personnel and medication are available to treat reactions," that for mild to moderate reactions during the infusion they "consider slowing or stopping the infusion," and that patients are monitored during the infusion, which is discontinued if a serious reaction occurs.

Prime Infusions has 13 infusion centers in New York, plus one in Atlanta, all open Monday to Friday, 9:00AM to 5:00PM. 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. Addresses are on our locations page.

Because infliximab maintenance runs on a fixed 6- or 8-week interval for years at a time, 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, and it is worth asking before a first appointment is booked.

Which type of site your plan will cover is a separate determination the plan makes. UnitedHealthcare's commercial policy "Provider Administered Drugs – Site of Care," Policy 2026D0121V, effective August 1, 2026, lists Renflexis, Remicade, Inflectra and Avsola 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 where 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 decision only that patient's plan can make.

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.

Expect prior authorization, and expect a step-therapy question about which infliximab product. Preferred-product lists are set by each plan and they change, so the only reliable answer is your own plan's current policy. What you should know going in is that on the two national commercial policies below, Renflexis is a non-preferred product. Learning that from your plan after the fact is worse than reading it here.

UnitedHealthcare, Commercial Medical Benefit Drug Policy "Infliximab (Avsola, Inflectra, Remicade, & Renflexis)," Policy 2026D0004AR, effective February 1, 2026, names Inflectra and Avsola as its preferred products. To obtain Remicade, Renflexis or another non-preferred infliximab under medical-necessity plans, 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," plus 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, likewise lists Avsola and Inflectra as preferred and names "infliximab (authorized generic), Remicade, Renflexis" as non-preferred, directing the patient to try at least one preferred product before a non-preferred one is approved. Its narrow exception applies where a patient tried Inflectra or Avsola and cannot continue because of "a formulation difference in the inactive ingredient(s)" that, according to the prescriber, would cause a significant allergy or serious adverse reaction. Both policies are national rather than New York-specific, and both carry 2026 effective dates — check the current version, because these lists are revised.

Medicare. Infliximab falls under Part B, not Part D, because it is administered by a clinician: CMS states that Part B covers drugs "provided as part of (or incident to) a physicians' service" and "generally … only drugs that are not usually self-administered." Medicare pays ASP plus 6% for most separately payable Part B drugs; for biosimilars the payment limit is the biosimilar's ASP plus 6% of the reference biological's ASP, or plus 8% for qualifying biosimilars. The Medicare contractor billing article for infliximab and biosimilars (A52423) requires documentation including patient weight, tuberculosis evaluation and treatment initiated before therapy, and inadequate response to a three-month trial of conventional non-biologic therapy — so TB screening is both a safety step and a claims requirement. What a Medicare beneficiary personally owes depends on the deductible, coinsurance and any supplemental coverage, and cannot be stated as a figure here.

Prime Infusions verifies benefits and submits the authorization request with your prescriber. Coverage, prior authorization and out-of-pocket cost are determined solely by your health plan, and no infusion provider can guarantee approval or payment.