Avsola (Infliximab-axxq) Infusion Therapy in New York

Most people reading this page did not pick Avsola. They were told - by their health plan, or by a prescriber's office relaying the plan's rule - that Avsola (infliximab-axxq) is the infliximab product the plan covers. That is now a common situation. On UnitedHealthcare Commercial Medical Benefit Drug Policy 2026D0004AR, effective February 1, 2026 and on Cigna Coverage Policy PSM005, effective 08/15/2026, Avsola is named a preferred product and the originator, Remicade, is named non-preferred. Most patients assume the reverse, which is why the letter is a surprise.

What does not change. Avsola is infliximab, given the same way infliximab has always been given here: an intravenous infusion in an infusion suite, billed under your medical benefit rather than picked up at a pharmacy counter. The FDA boxed warning is the same one carried by Remicade and by the other infliximab biosimilars, headed "WARNING: SERIOUS INFECTIONS and MALIGNANCY", and the tuberculosis screening it requires before and during therapy applies unchanged. Medicare's contractor billing article for infliximab and biosimilars (A52423) covers Avsola and asks for the same documentation - patient weight, and tuberculosis evaluation and treatment initiated before therapy.

What does change. The manufacturer is Amgen rather than Janssen Biotech. The nonproprietary name carries the FDA-assigned four-letter suffix, infliximab-axxq. The claim your plan sees uses HCPCS code Q5121, effective July 1, 2020, rather than J1745. And your prescriber writes the order for Avsola by name.

What FDA's standard says, and what it does not. Avsola was licensed under section 351(k) of the Public Health Service Act on data demonstrating that it is "highly similar" to the reference product with "no clinically meaningful differences" between them. That is the standard the product met at approval - it is not a prediction about how any one person will do. Prime Infusions does not recommend one infliximab product over another; that choice belongs to your prescriber and your plan. Questions about what a change of product means for you personally belong with the clinician who prescribes it.

No. A generic is a chemically identical copy of a small-molecule drug. Avsola is a biosimilar, which is a different regulatory category for a different kind of medicine. 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 reference product here is Remicade, licensed under section 351(a) of the Public Health Service Act, initial U.S. approval 1998. Avsola is licensed under section 351(k) - BLA 761086, Amgen Inc., approved December 6, 2019.

The Avsola prescribing information carries FDA's fuller wording 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."

Avsola is not an interchangeable biosimilar - and neither is any other infliximab product. In the FDA Purple Book, Avsola (BLA 761086), Inflectra (infliximab-dyyb, BLA 125544, Celltrion, April 5, 2016) and Renflexis (infliximab-abda, BLA 761054, Samsung Bioepis, April 21, 2017) are each listed as "351(k) Biosimilar," and none appears with an interchangeability designation on FDA's biosimilar product list. 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 designation about who may swap the product, not a ranking of how well products work.

In practice that means two things in New York. First, Education Law § 6816-a lets a pharmacist substitute a biological product only where the substitute is an interchangeable biological product for the one prescribed - so that substitution pathway is simply not available for infliximab. Second, infliximab is provider-administered under the medical benefit, not dispensed at retail, so there is no pharmacy substitution step in the workflow at all. The product you receive is the one your prescriber orders, interacting with your plan's preferred-product policy. Nobody swaps it behind the counter.

Avsola is FDA-approved for all eight infliximab indications carried by its reference product, in the same populations. The table below is section 1 of Avsola's own FDA-approved prescribing information on DailyMed (Amgen, revised 9/2025). It is worth saying explicitly, because a biosimilar is sometimes approved for fewer indications than its reference product — individual indications can still be protected at the time the biosimilar is licensed. Avsola's label carries all eight, and your prescriber can confirm which one your order is written for.

Two details that are easy to misread. Rheumatoid arthritis is a combination indication - the labeled wording is "in combination with methotrexate," not infliximab on its own. And the pediatric indications stop at Crohn's disease and ulcerative colitis in patients 6 years and older. There is no pediatric indication for rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis or plaque psoriasis; those three are adult-only.

Off-label use, stated plainly. Any use outside the labeled indications - hidradenitis suppurativa, uveitis, sarcoidosis, Behcet's disease, pyoderma gangrenosum, graft-versus-host disease, or any pediatric use other than Crohn's disease and ulcerative colitis at age 6 and older - is off-label, meaning FDA has not approved infliximab for it. Medicare contractor billing guidance does contemplate infliximab claims for pyoderma gangrenosum with coexisting inflammatory bowel disease under specific paired ICD-10 rules, but that is a coverage pathway, not an FDA indication.

One formulation note: subcutaneous infliximab is a separate product with its own labeling, dispensed under the pharmacy benefit rather than infused in a center. Avsola is intravenous; there is no self-injected or oral form of it.

Avsola is given by intravenous infusion, and the dose is weight-based in mg/kg - which is why your weight is recorded before every visit rather than taken once at the start. The FDA-approved prescribing information for the reference product sets the same induction pattern for every indication: infusions at weeks 0, 2 and 6, then a maintenance interval that depends on the diagnosis.

Two lines in that table catch people out. Rheumatoid arthritis is the only indication that starts at 3 mg/kg rather than 5 mg/kg, and ankylosing spondylitis is the only one maintained every 6 weeks rather than every 8. Confirm your own dose and interval against the prescribing information for the product you actually receive, and with the prescriber who wrote the order.

The infusion itself takes at least two hours. That floor is not a scheduling convention or a clinic preference - it is the labeled administration instruction: "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 US labeling contains no shortened or one-hour infusion option, so a faster protocol would be an off-label administration practice. Your total time at the center is longer than the infusion, because the visit also includes check-in and a weight, vascular access and pre-infusion assessment, any premedication your prescriber ordered, preparation of the drug, and monitoring afterward. We do not publish a total visit length here - ask the center scheduling your appointment.

Premedication is permissive in the labeling, not required: patients "may be premedicated with histamine-1 receptor antagonists, histamine-2 receptor antagonists, acetaminophen, and/or corticosteroids." Whether you receive any of that is your prescriber's decision, not a routine step.

Avsola carries an FDA boxed warning - the most serious warning FDA requires on a prescription label - headed "WARNING: SERIOUS INFECTIONS and MALIGNANCY". It is the same boxed warning that appears on Remicade and on the other infliximab biosimilars, with the product name substituted. Its substance is set out here in full, because an abbreviated version of it would be misleading.

Serious infections

Patients treated with Avsola are at increased risk for developing serious infections that may lead to hospitalization or death. Most patients who developed these infections were taking concomitant immunosuppressants such as methotrexate or corticosteroids. Avsola 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 Avsola use and during therapy, and treatment for latent infection should be initiated prior to Avsola use.
• Invasive fungal infections, including histoplasmosis, coccidioidomycosis, candidiasis, aspergillosis, blastomycosis and pneumocystosis. Patients with histoplasmosis or other invasive fungal infections may present with disseminated, rather than localized, disease. 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.
• 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 before starting therapy.

Malignancy

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

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. 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.

Read the complete boxed warning and the full prescribing information on the Avsola label before starting therapy, and discuss your own risk factors with your treating clinician.

The FDA-approved prescribing information for the reference product reports the adverse reactions below from its rheumatoid arthritis clinical trials, in patients who received four or more infusions, at a rate of 5% or more. The label's own caveat travels with these numbers: clinical trial rates are observed under widely varying conditions and cannot be directly compared with rates from other trials or with rates seen in practice.

Infusion reactions are the ones that happen while you are still in the chair. In the labeled trials, "approximately 20% of REMICADE-treated patients experienced an infusion reaction compared with 10% of placebo-treated patients," occurring during the infusion or within one hour after it. Across all infusions, 3% were accompanied by nonspecific symptoms such as fever or chills, 1% by cardiopulmonary reactions - primarily chest pain, hypotension, hypertension or dyspnea - and under 1% by pruritus or urticaria. The label also records that "serious infusion reactions occurred in <1% of patients and included anaphylaxis, convulsions, erythematous rash and hypotension."

So roughly one in five patients has some infusion reaction; most are mild, and fewer than 1% are serious. That is precisely why the infusion is supervised rather than self-administered. The labeling directs that before 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 clinicians "monitor patients during infusion and if serious reaction occurs, discontinue infusion." Tell your nurse straight away if you feel flushed, short of breath, itchy, dizzy or unwell at any point - slowing or pausing the infusion is a normal, expected response, not a failure.

Pediatric adverse reaction rates are reported separately in the labeling and are not the adult figures above; ask your child's gastroenterologist for the pediatric data that applies. The full side-effect profile, including the risks in the boxed warning above, is in the complete prescribing information and on the Avsola label.

Prime Infusions operates 13 infusion centers across New York, plus one in Atlanta. In New York City that is Brooklyn and Boro Park in Brooklyn; Fresh Meadows, Astoria, Jamaica and Howard Beach in Queens; the Upper East Side in Manhattan; and Staten Island. On Long Island, Great Neck in Nassau County, Inwood in the Five Towns and Port Jefferson Station in Suffolk County. North of the city, New City in Rockland County and Monroe in Orange County. Addresses are on our locations page. We do not publish which center stocks which product - our care team confirms the location that can schedule your infusion when the referral is processed.

Site of care

Where an infusion is given is increasingly a payer question. UnitedHealthcare's commercial policy "Provider Administered Drugs - Site of Care," Policy 2026D0121V, effective August 1, 2026, expressly lists Avsola alongside Remicade, Inflectra and Renflexis, 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. If an individual does not meet criteria for outpatient hospital facility infusion, alternative sites of care may be used." Whether that applies to any individual is a determination only that plan can make.

Prior authorization and step therapy

Expect prior authorization, and expect a step-therapy question about which infliximab product. UnitedHealthcare 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 it 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 Coverage Policy PSM005 (effective 08/15/2026) likewise names "Avsola, Inflectra" preferred and "infliximab (authorized generic), Remicade, Renflexis" non-preferred, directing the patient to try at least one preferred product before a non-preferred one is approved. If Avsola is your plan's preferred product, the step-therapy burden runs the other way: it is the originator that would need the documented trial or documented intolerance. Both are national policies, not New York-specific ones, and preferred-product lists change.

Prime Infusions verifies benefits and submits the authorization request together with your prescriber. Coverage, prior authorization and out-of-pocket cost are determined solely by your health plan; we cannot guarantee approval. Physicians can start a referral through our Treatment Referrals directory; patients can contact us or call 718-443-4000, Monday to Friday, 9:00AM to 5:00PM.