Remicade biosimilars: FDA status, payer coverage, switching, and coding

Remicade (infliximab, Janssen/Johnson & Johnson) is a tumor necrosis factor-alpha (TNF-alpha) inhibitor originally approved by the FDA in 1998. It is administered by intravenous infusion and is indicated for Crohn's disease, ulcerative colitis, rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis, and plaque psoriasis. Five biosimilars have been approved in the US, and a subcutaneous formulation entered the market in 2024. Payers are accelerating the transition from branded Remicade to preferred biosimilars.

This reference-product dossier is for prescribers, access teams, pharmacists, hospital formulary committees, and payer professionals tracking the infliximab biosimilar landscape.

FDA-approved biosimilars

As of May 2026, five biosimilars referencing Remicade have been approved by the FDA, plus a subcutaneous formulation approved under a standalone BLA:

In addition, Janssen markets unbranded infliximab (100 mg single-dose vial, NDC 57894-0160) under the Remicade BLA.

Interchangeability

None of the five IV infliximab biosimilars carry the FDA interchangeable designation. This means pharmacy-level substitution is not automatically permitted; prescribers must specifically order the biosimilar product. However, the FDA has signaled plans to finalize guidance that may merge the biosimilarity and interchangeability pathways, potentially making all new biosimilars interchangeable by default starting in 2026.

Zymfentra (subcutaneous infliximab)

Zymfentra is the first and only FDA-approved subcutaneous infliximab product, approved under a standalone BLA (not as a biosimilar). Key details:

• Indicated for maintenance treatment of moderately to severely active ulcerative colitis and Crohn's disease in adults, following IV induction with any infliximab product
• Not indicated for rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis, plaque psoriasis, or fistulizing Crohn's disease
• Dosing: 120 mg SC every 2 weeks, starting at week 10 after IV induction
• Patent-protected through 2037 (dosage form) and 2040 (route of administration)
• Commercially available since March 15, 2024

Indications

All four marketed IV biosimilars (Inflectra, Renflexis, Avsola, and unbranded infliximab) share the same FDA-approved indications as Remicade:

• Crohn's disease (adults and pediatric): reducing signs and symptoms, inducing and maintaining clinical remission
• Ulcerative colitis (adults and pediatric): reducing signs and symptoms, inducing and maintaining remission
• Rheumatoid arthritis (adults): in combination with methotrexate
• Ankylosing spondylitis (adults): reducing signs and symptoms
• Psoriatic arthritis (adults): reducing signs and symptoms
• Plaque psoriasis (adults): chronic severe plaque psoriasis

Formulations

All IV products are supplied as 100 mg single-dose vials for reconstitution. Zymfentra is supplied as a 120 mg/mL single-dose prefilled pen for subcutaneous injection.

Payer and PBM coverage

Payers have moved aggressively to prefer infliximab biosimilars over branded Remicade. Several major payers implemented step therapy or exclusion of Remicade effective January 2026.

Point32Health (Harvard Pilgrim / Tufts Health Plan)

Effective January 1, 2026, Avsola and Inflectra are the preferred infliximab products across Harvard Pilgrim Commercial, Tufts Health Plan Commercial, Tufts Health Direct, Tufts Medicare Preferred, Tufts Health Plan Senior Care Options, and Tufts Health One Care. Remicade and unbranded infliximab became non-preferred. Members transitioning from Remicade or unbranded infliximab do not need a new prior authorization for Avsola or Inflectra.

Blue Shield of California

For Blue Shield Select (PPO) and Medicare (PPO) plans, Avsola and Inflectra are the preferred step drugs. Members newly initiating Remicade, Renflexis, or unbranded infliximab must first try both Avsola and Inflectra before coverage is authorized. Remicade requires documented intolerance or contraindication to all preferred biosimilars.

UnitedHealthcare

UnitedHealthcare's medical benefit drug policy (effective February 2026) covers Avsola, Inflectra, Renflexis, and Remicade for all FDA-approved indications. The policy does not mandate a specific preferred product but requires prior authorization and documentation of conventional therapy failure.

Blue Cross Blue Shield of Michigan

BCBSM's infliximab policy covers all products (Avsola, Inflectra, Ixifi, Remicade, Renflexis, Zymfentra) with prior authorization. Coverage requires documented diagnosis, prior conventional therapy failure (e.g., corticosteroids, immunomodulators), and specialist consultation for certain indications.

Medicaid (varies by state)

State Medicaid programs increasingly prefer biosimilars. Common requirements:

• Prior authorization required for all infliximab products
• Step therapy through preferred biosimilars (typically Avsola and/or Inflectra) before Remicade
• Remicade coverage requires documented intolerance to all preferred biosimilars
• Reauthorization every 12 months with evidence of clinical response

Summary of payer preference patterns

HCPCS coding and reimbursement

Infliximab products are billed under medical benefit using the following HCPCS codes:

One billable unit equals 10 mg for all codes. Standard dosing is up to 5 mg/kg IV at weeks 0, 2, and 6 (induction), then every 8 weeks (maintenance). Dose escalation to 10 mg/kg is permitted for certain indications.

Under Medicare Part B, biosimilar reimbursement follows the biosimilar average sales price (ASP) plus 4% of the reference product ASP. Hospital outpatient departments bill under the OPPS, where biosimilars receive pass-through status in some cases.

Switching considerations

IV to IV switching

Switching between Remicade and its IV biosimilars is supported by multiple clinical studies. A systematic review of switching studies found no clinically meaningful differences in efficacy, safety, or immunogenicity between patients who switched from reference infliximab to biosimilar versus those who remained on reference infliximab. Key points:

• Switching is typically done at the next scheduled infusion (no washout required)
• No dose adjustment needed when switching between IV products
• Monitor for infusion reactions, particularly after the first switched dose
• Some payers require documentation of medical necessity or intolerance before allowing a switch back to Remicade

IV to subcutaneous (Zymfentra)

Transitioning from IV infliximab to Zymfentra (SC) requires:

1. Completion of IV induction (weeks 0, 2, 6)
2. Confirmation of clinical response at week 10 or later
3. Initiation of Zymfentra 120 mg SC every 2 weeks
4. No washout period required; transition at next scheduled IV dose

Zymfentra is only approved for UC and CD maintenance. Patients with RA, PsA, AS, or plaque psoriasis cannot be switched to Zymfentra.

Hospital formulary switching

Hospital and health system formulary committees should consider:

• Contracting: preferred biosimilar status may yield significant cost savings (20-35% discount vs. Remicade)
• Payer alignment: select preferred products that align with major local payer formularies
• Operational: ensure EMR order sets, pharmacy inventory, and nursing protocols are updated for the preferred product(s)
• Communication: notify prescribers and patients of any formulary change with adequate lead time
• Monitoring: track clinical outcomes, immunogenicity, and infusion reaction rates post-switch

Market dynamics and cost savings

Infliximab biosimilar utilization has steadily increased since the first biosimilar (Inflectra) entered the US market in 2016. An AJMC study analyzing commercial insurance claims found that biosimilar competition contributed to significant healthcare savings and a decrease in the total cost of both Remicade and its biosimilars. Key data points:

• In Europe, biosimilars accounted for over 60% of infliximab prescriptions in 2025, compared with lower but growing adoption in the US
• Biosimilars entered the market with discounts of 20-35% off Remicade's list price
• Remicade's net price began declining in 2016 as the manufacturer prepared for Inflectra's launch, and has continued to fall as additional biosimilars entered
• US adoption has been slower than Europe, partly due to contracting strategies that historically kept Remicade on Tier 1 formulary positions in exchange for rebates
• The trend is shifting: multiple payers now require step therapy through biosimilars before covering Remicade, accelerating the transition

Patient support and affordability

Manufacturer programs

Buy-and-bill vs. specialty pharmacy

Infliximab is typically purchased and billed by the administering provider (buy-and-bill model) under medical benefit. Zymfentra (SC) may be dispensed through specialty pharmacy under pharmacy benefit depending on the payer.

What to monitor next

• FDA interchangeability guidance: The FDA plans to finalize draft guidance in 2026 that could merge biosimilarity and interchangeability, potentially making all infliximab biosimilars interchangeable and enabling pharmacy-level substitution
• Zymfentra expansion: Celltrion may seek additional indications for subcutaneous infliximab beyond UC and CD. Watch for clinical trial data in RA and PsA
• Payer exclusions: Additional payers are expected to exclude Remicade in favor of biosimilars during 2026-2027, following the pattern set by Point32Health and Blue Shield of California
• New infliximab biosimilar filings: Check the FDA biosimilar pipeline for any additional infliximab biosimilar applications

Disclaimer

This article is for informational purposes only and does not constitute medical advice. Coverage, formulary placement, and prior authorization criteria vary by plan and change frequently. Always verify current requirements with the patient's specific payer.

Sources

• FDA. Biosimilar Product Information. https://www.fda.gov/drugs/biosimilars/biosimilar-product-information
• Point32Health. Coverage changes for Remicade and biosimilars. https://www.point32health.org/provider/coverage-changes-remicade-and-biosimilars-112025
• UnitedHealthcare. Infliximab medical benefit drug policy. https://www.uhcprovider.com/content/dam/provider/docs/public/policies/comm-medical-drug/infliximab-remicade-inflectra.pdf
• Blue Shield of California. Infliximab medical benefit drug policy. https://www.blueshieldca.com/content/dam/bsca/en/provider/docs/medi-cal-med-benefit-drug-policy/infliximab-MCAL-UMRx-provider.pdf
• BCBS Michigan. Infliximab policy. https://www.bcbsm.com/amslibs/content/dam/public/mpr/mprsearch/pdf/2067530.pdf
• Celltrion USA. Zymfentra prescribing information. https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/761358Orig1s001lbl.pdf
• Gabionline. Biosimilars approved in the US. https://gabionline.net/biosimilars/general/biosimilars-approved-in-the-us
• Jones Day. FDA's Biosimilar Playbook. https://www.jonesday.com/en/insights/2025/12/fda-biosimilar-playbook-merging-biosimilarity-with-interchangeability
• Paglinco SR, et al. The Biosimilar Shift: Infliximab Biosimilar Utilization and Cost Savings. https://www.ajmc.com/view/the-biosimilar-shift-trending-infliximab-biosimilar-utilization-and-associated-cost-savings-for-commercial-insurance