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TNF inhibitor access landscape: Humira, Enbrel, Remicade, Cimzia, and Simponi in 2026

TNF inhibitor access in 2026: formulary tiers, biosimilar adoption, PA, and step therapy for Humira, Enbrel, Remicade, Cimzia, and Simponi across commercial payers and Medicare.

Ran Chen
Ran Chen
14 min read · Published · Source-cited

Tumor necrosis factor (TNF) inhibitors remain the most prescribed biologic class for autoimmune and inflammatory diseases, with a global market valued at approximately $30.9 billion in 2026. But the access landscape is shifting fast. Biosimilar adalimumab products now account for nearly 31% of TNF inhibitor revenue in developed regions. Infliximab biosimilars have driven reference-product erosion above 90% in some European tender systems. Etanercept and golimumab biosimilars are entering the market. Payers are moving preferred formulary positions to lower-cost biosimilars, creating new step-therapy ladders that prescribers and access teams must navigate.

This landscape guide covers the five originator TNF inhibitors — Humira (adalimumab), Enbrel (etanercept), Remicade (infliximab), Cimzia (certolizumab pegol), and Simponi/Simponi Aria (golimumab) — plus their biosimilars. It is for market access teams, formulary decision-makers, benefit verification specialists, and prescribers who need to understand payer positioning, prior authorization criteria, step therapy, and switching dynamics. It is not medical advice or reimbursement guidance for a specific patient or plan.

Quick answer

Drug Route Biosimilar Status (2026) Formulary Trend Typical PA Duration
Humira (adalimumab) SC 10 FDA-approved biosimilars; 8 interchangeable Originator removed from many Medicare formularies; adalimumab biosimilars preferred 6–12 months
Enbrel (etanercept) SC Erelzi and Eticovo approved but not marketed; patent estate blocking entry Maintains preferred position on many formularies due to lack of biosimilar competition 12 months
Remicade (infliximab) IV Inflectra, Renflexis, Avsola marketed; Zymfentra (SC) approved IV biosimilars preferred on most formularies; Remicade retains buy-and-bill for infusion centers 12 months
Cimzia (certolizumab) SC No approved biosimilars Non-preferred on many step-therapy protocols; requires prior TNF failure 6 months initial
Simponi (golimumab SC) / Simponi Aria (golimumab IV) SC / IV Immgolis (golimumab-sldi) approved May 2026 Non-preferred; typically requires prior adalimumab and Enbrel failure 12 months

Who this is for

  • Market access and payer strategy teams at pharmaceutical manufacturers
  • Benefit verification and prior authorization specialists
  • Prescribers (rheumatologists, gastroenterologists, dermatologists) managing TNF inhibitor access
  • Formulary committees and PBM decision-makers
  • Specialty pharmacy operators coordinating TNF inhibitor fulfillment

Source standard

Every fact in this guide is sourced from payer policy documents, FDA Purple Book data, formulary files, published market analyses, and trade reporting dated 2025–2026. Payer coverage rules change frequently. Always verify current formulary and PA criteria on the specific plan's portal before submitting authorization.

TNF inhibitor reference table

Originator Generic Mechanism FDA-Approved Indications Route Frequency
Humira Adalimumab TNF-alpha inhibitor RA, PsA, AS, CD, UC, PsO, HS, JIA, uveitis SC Every 2 weeks
Enbrel Etanercept TNF receptor fusion protein RA, PsA, AS, PsO, JIA SC Weekly
Remicade Infliximab Chimeric anti-TNF-alpha mAb RA, PsA, AS, CD, UC, PsO IV infusion Every 6–8 weeks after loading
Cimzia Certolizumab pegol PEGylated anti-TNF Fab RA, PsA, AS, CD, PsO, nr-axSpA, JIA SC Every 2–4 weeks
Simponi Golimumab Human anti-TNF-alpha mAb RA, PsA, AS, UC SC Monthly
Simponi Aria Golimumab Human anti-TNF-alpha mAb RA, PsA, AS, PJIA IV infusion Every 8 weeks after loading

Biosimilar landscape by molecule

Adalimumab (Humira and biosimilars)

Humira has the deepest biosimilar penetration of any TNF inhibitor. As of 2026:

  • 10 FDA-approved adalimumab biosimilars are on the US market: Amjevita, Cyltezo, Hadlima, Hulio, Hyrimoz, Idacio, Simlandi, Yuflyma, Yusimry, and Abrilada
  • Interchangeable products: Eight of the ten biosimilars carry the FDA interchangeable designation — Amjevita, Cyltezo, Hyrimoz, Hadlima, Abrilada, Hulio, Yuflyma, and Simlandi — permitting pharmacy-level substitution in states that allow it
  • Formulary impact: Multiple Medicare Advantage and commercial plans have removed originator Humira from formulary entirely, substituting preferred adalimumab biosimilars. AmeriHealth Caritas VIP Care removed Humira from its Medicare formulary effective January 1, 2026, replacing it with adalimumab-fkjp and Simlandi
  • Market data: AbbVie reported a 36% year-over-year decline in Humira revenue as biosimilar competition accelerated, offset by Skyrizi and Rinvoq growth

Etanercept (Enbrel and biosimilars)

Enbrel's biosimilar landscape is unique because of patent-related barriers:

  • Erelzi (Sandoz, etanercept-szzs): FDA-approved August 2016 for all Enbrel indications. Not marketed in the US due to ongoing patent litigation and a stipulated preliminary injunction in Immunex v. Sandoz
  • Eticovo (Samsung Bioepis, etanercept-ykro): FDA-approved April 2019. Not marketed in the US
  • Net effect: Despite two approved biosimilars, neither is commercially available in the US, and Enbrel retains exclusive market position. This preserves Enbrel's preferred formulary status on many plans but at brand-tier pricing

Infliximab (Remicade and biosimilars)

Remicade biosimilars are the most established in the TNF class:

  • Inflectra (Celltrion/Pfizer, infliximab-dyyb): Approved 2016, marketed for all Remicade indications
  • Renflexis (Samsung Bioepis/Organon, infliximab-abda): Approved 2017, marketed
  • Avsola (Amgen, infliximab-axxq): Approved 2019, marketed
  • Zymfentra (infliximab-dyyb SC): First subcutaneous infliximab formulation, approved for Crohn's disease and ulcerative colitis maintenance
  • Ixifi (Pfizer, infliximab-qbtx): Approved 2017; launched commercially in Canada April 2026 but not marketed in the US

Infliximab biosimilars are preferred over Remicade on most major formularies. The IV route creates medical-benefit billing complexity that SC TNF inhibitors avoid, but infusion centers retain buy-and-bill economics with biosimilar products.

Certolizumab pegol (Cimzia)

  • No approved biosimilars as of June 2026
  • Patent protections remain active
  • Cimzia occupies a niche in formulary step-therapy protocols: it is often designated non-preferred, requiring documented failure of a preferred TNF inhibitor (typically adalimumab or Enbrel) before coverage

Golimumab (Simponi and Simponi Aria)

  • Immgolis / Immgolis Intri (golimumab-sldi, Bio-Thera/Accord BioPharma): FDA-approved May 2026 for Simponi and Simponi Aria indications. This is the first golimumab biosimilar
  • AVT05 (Alvotech/Teva): A complete response letter was issued by FDA in November 2025
  • Simponi (SC) and Simponi Aria (IV) remain non-preferred on most step-therapy protocols, typically requiring prior TNF failure

Payer formulary positioning

Preferred vs. non-preferred TNF inhibitors

Payers are consolidating TNF inhibitor formularies around preferred products, creating step-therapy cascades:

Payer Preferred TNF Inhibitors Non-Preferred (requires step therapy)
BCBS Massachusetts Adalimumab biosimilars (Hadlima, Simlandi); Enbrel; Infliximab biosimilars (Avsola, Inflectra) Cimzia; Remicade; Humira brand
Cigna Enbrel; adalimumab-adbm, Cyltezo, adalimumab-adaz, Simlandi Cimzia (requires 2 preferred TNF failures); non-preferred adalimumab products
Health Net / Centene Adalimumab biosimilars (Humira, Hadlima, adalimumab-adaz); Enbrel Cimzia (requires adalimumab + Enbrel failure); Simponi; Taltz; Bimzelx
UnitedHealthcare Enbrel; adalimumab products Cimzia; Simponi (requires prior TNF failure documentation)
Medicare Part D Varies by plan; adalimumab biosimilars increasingly preferred Originator Humira removed from many plans

Step therapy hierarchy

The typical TNF inhibitor step-therapy cascade across major payers in 2026:

  1. Step 1 — Conventional DMARDs: Methotrexate, sulfasalazine, hydroxychloroquine, or leflunomide for ≥3 months (unless contraindicated)
  2. Step 2 — Preferred TNF inhibitor: An adalimumab biosimilar product or Enbrel for ≥3 months
  3. Step 3 — Second preferred TNF inhibitor or mechanism switch: If first TNF fails, try the other preferred TNF (adalimumab after Enbrel failure, or vice versa) OR switch to a different mechanism (IL-6 inhibitor, JAK inhibitor, IL-23 inhibitor)
  4. Step 4 — Non-preferred TNF inhibitors: Cimzia, Simponi, or other non-preferred products may be covered after documented failure of preferred TNF inhibitors

Key step-therapy rules from payer policies

Health Net (Centene) — representative of tiered DMARD policies:

  • For Cimzia, Bimzelx, SC Orencia, Simponi, or Taltz (age ≥18): patient must meet all three requirements:
    1. Failure of both an adalimumab product AND Enbrel, each used ≥3 consecutive months; OR if history of failure of one TNF blocker, then failure of one alternative TNF blocker for ≥3 months
    2. Failure of at least one DMARD (methotrexate, sulfasalazine, leflunomide, or hydroxychloroquine)
    3. Prescribed by or in consultation with a rheumatologist, gastroenterologist, or dermatologist

Cigna — preferred specialty management:

  • Cimzia is non-preferred for all indications
  • For RA initial therapy: patient must have tried two of the following: tocilizumab SC, Enbrel, an adalimumab product, Rinvoq, or Xeljanz
  • Trial of an infliximab product, Simponi, or Stelara also counts toward the requirement

Prior authorization by drug

Adalimumab (Humira and biosimilars)

  • Required for most plans: Yes
  • Specialty benefit: Pharmacy benefit (SC injection, patient self-administered)
  • Typical criteria: Diagnosis of RA, PsA, AS, CD, UC, PsO, or HS; ≥18 years (or JIA for specific products); prescribed by specialist; failure of conventional DMARD therapy; not on combination with another systemic targeted immunomodulator
  • Approval duration: 6–12 months
  • Reauthorization: Positive clinical response documented; no combination with another biologic or JAK inhibitor

Enbrel (etanercept)

  • Required: Yes for most plans
  • Specialty benefit: Pharmacy benefit (SC injection)
  • Typical criteria (from UHC policy and Mass General Brigham): Diagnosis of RA, PsA, AS, PsO, or JIA; NSAID failure for AS (≥2 NSAIDs for ≥4 weeks each); DMARD failure for RA; ≥3% BSA or crucial body areas for PsO; positive clinical response for reauthorization
  • Approval duration: 12 months (UHC); 24 months (Mass General Brigham)
  • Notable: Enbrel retains preferred formulary position on many plans because no etanercept biosimilar is commercially available in the US

Infliximab (Remicade and biosimilars)

  • Required: Yes
  • Benefit type: Medical benefit (IV infusion, provider-administered)
  • Typical criteria (from UHC policy): Diagnosis-specific; inadequate response to conventional therapy for CD/UC; DMARD failure for RA; NSAID failure for AS; no combination with another systemic targeted immunomodulator
  • Approval duration: Initial: ≤4 doses or 12 months; reauthorization: 12 months with documented positive clinical response
  • Coding: J-code for buy-and-bill billing; biosimilar products have separate billing codes
  • Notable: The IV route means infliximab is processed through the medical benefit, not the pharmacy benefit, creating a different PA pathway than SC TNF inhibitors

Cimzia (certolizumab pegol)

  • Required: Yes
  • Specialty benefit: Pharmacy benefit (SC injection)
  • Typical criteria (from Cigna PA policy): Diagnosis-specific; ≥18 years; prescribed by specialist; DMARD failure for RA; conventional therapy failure for CD; PsO criteria (≥3% BSA); not on combination biologic therapy
  • Approval duration: 6 months initial; 12 months reauthorization
  • Non-preferred status: Most payers designate Cimzia as non-preferred, requiring documented failure of preferred TNF inhibitors before coverage. Exceptions include pregnancy/breastfeeding (Cimzia has a labeled use in these populations) and specific formulary positions

Simponi / Simponi Aria (golimumab)

  • Required: Yes
  • Benefit type: Simponi = pharmacy benefit (SC); Simponi Aria = medical benefit (IV infusion)
  • Typical criteria (from UHC policy): Diagnosis of RA, PsA, AS, or UC; NSAID failure for AS; DMARD failure for RA; not on combination with another systemic targeted immunomodulator; positive clinical response for reauthorization
  • Approval duration: 12 months
  • Notable: Simponi is typically non-preferred on formulary step-therapy protocols, requiring prior TNF inhibitor failure. The newly approved Immgolis biosimilar may shift formulary positioning later in 2026

Medicare coverage

Medicare covers TNF inhibitors through Part D (SC formulations) or Part B (IV infusions):

  • Part D (SC products): Adalimumab, Enbrel, Cimzia, Simponi are covered under the pharmacy benefit. Part D plans are increasingly designating adalimumab biosimilars as preferred, removing originator Humira from formularies. PA required by most plans
  • Part B (IV infusions): Remicade and infliximab biosimilars are covered under the medical benefit with buy-and-bill reimbursement. Biosimilar infliximab products receive Part B add-on payment incentives
  • Step therapy: Medicare Advantage plans may apply step-therapy requirements for TNF inhibitors, typically requiring DMARD failure before biologic approval
  • Cost sharing: Under the 2026 Part D redesign, the annual out-of-pocket cap is $2,100. Specialty-tier TNF inhibitors may still require significant coinsurance before reaching the cap

Medicaid coverage

Medicaid programs generally cover TNF inhibitors with prior authorization:

  • DMARD-first requirement: Nearly all state Medicaid programs require documented failure of conventional DMARDs before approving a biologic TNF inhibitor
  • Preferred product lists: State Medicaid programs maintain preferred product lists that favor lower-cost biosimilars. Originator Humira has been removed from many state Medicaid formularies in favor of adalimumab biosimilars
  • Specialist prescriber requirements: Most states require TNF inhibitors to be prescribed by or in consultation with a rheumatologist, gastroenterologist, or dermatologist
  • Approval duration: Typically 6–12 months with documented clinical response for reauthorization

Switching considerations

Payer-driven switching from originator to biosimilar TNF inhibitors raises clinical and operational questions:

Pharmacy-level substitution (interchangeable biosimilars)

  • Cyltezo and Simlandi (adalimumab biosimilars) have FDA interchangeability designations
  • State laws govern pharmacy substitution: some states require prescriber notification, some require patient consent, and some permit automatic substitution
  • Access teams should track state-specific interchangeability notification requirements

Medical switching (non-interchangeable biosimilars)

  • For non-interchangeable biosimilars, payers use formulary exclusion, step therapy, or prior authorization to drive switching
  • Providers may need to submit new PA requests with documented clinical justification for the biosimilar product
  • Infliximab switching at infusion centers typically involves coordination between the prescribing physician, infusion center pharmacy, and payer

Switching stability monitoring

  • Document baseline disease activity before switching
  • Monitor for loss of response in the 3–6 months after a switch
  • Pay attention to immunogenicity: anti-drug antibodies may develop differently against biosimilar products
  • Maintain records of switching rationale and clinical outcomes for future PA reauthorization

What changed recently

  • Golimumab biosimilar approval: FDA approved Immgolis (golimumab-sldi) in May 2026, the first biosimilar to Simponi and Simponi Aria. Market entry will depend on patent and litigation timelines
  • Adalimumab biosimilar consolidation: With 10 adalimumab biosimilars competing, pricing has compressed significantly. Plans are aggressively moving to preferred biosimilar positions. The Big 3 PBMs (CVS Caremark, Express Scripts, Optum Rx) have removed originator Humira from their 2026 standard formularies, according to Drug Channels analysis, replacing it with preferred biosimilars — often private-label products affiliated with the PBM's parent company
  • Humira Medicare formulary removal: Multiple Medicare Advantage plans removed originator Humira from formularies for 2026, substituting adalimumab biosimilars. Point32Health (Harvard Pilgrim, Tufts Health Plan) designated Simlandi as preferred effective March 2026, with Humira moved to non-preferred, non-formulary status requiring step therapy through all preferred biosimilars
  • Zymfentra (SC infliximab): The first subcutaneous infliximab formulation is now available for Crohn's disease and ulcerative colitis maintenance, creating a new option that avoids IV infusion logistics
  • Class-level competition from IL-23 and JAK: Skyrizi, Rinvoq, and other next-generation mechanisms are increasingly used as first-line biologic therapy, reducing TNF inhibitor market share in naive patients

What to monitor next

  • Etanercept biosimilar commercial launch: Monitor Erelzi and Eticovo litigation outcomes. A commercial launch would shift Enbrel formulary positioning and create a new biosimilar option
  • Golimumab biosimilar market entry: Track Immgolis commercial availability and payer formulary adoption
  • Certolizumab biosimilar pipeline: Monitor ANDA/BLA filings for certolizumab pegol biosimilars
  • IRA Part B biosimilar incentive: If TNF inhibitor infliximab products are affected by IRA negotiation or Part B biosimilar incentive programs, reimbursement dynamics could shift
  • State step-therapy reform legislation: Multiple states are passing laws limiting step-therapy requirements for biologics. Monitor state legislative activity for changes that could simplify TNF inhibitor PA pathways

Sources

Topics
BiosimilarsTNF InhibitorPayer CoveragePrior AuthorizationStep TherapyCommercial PayerMedicare Part DMedicaidSpecialty Drugs
Ran Chen
Contributing Editor
Ran Chen

Founder, PharmaDossier. Life-sciences operator covering market access, specialty pharma, biosimilars, and regulated healthcare growth.

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