Simponi (golimumab, SC injection) and Simponi Aria (golimumab, IV infusion) are Janssen Biotech TNF inhibitors approved for rheumatoid arthritis (RA), psoriatic arthritis (PsA), ankylosing spondylitis (AS), polyarticular juvenile idiopathic arthritis (pJIA), and — for Simponi SC only — ulcerative colitis (UC). In May 2026, the FDA approved the first biosimilars: Immgolis (golimumab-sldi, referencing Simponi SC) and Immgolis Intri (golimumab-sldi, referencing Simponi Aria IV), both designated interchangeable.
However, Janssen has filed a preliminary injunction motion in the District of Delaware to block their launch. The biosimilar sponsor, Accord BioPharma (commercializing partner for Bio-Thera Solutions), plans availability in Q4 2026 if litigation is resolved. This guide covers the golimumab biosimilar landscape, benefit routing, coding, payer policies, and timing considerations for access teams.
Quick comparison
| Simponi (golimumab SC) | Simponi Aria (golimumab IV) | Immgolis (golimumab-sldi SC) | Immgolis Intri (golimumab-sldi IV) | |
|---|---|---|---|---|
| Developer | Janssen Biotech | Janssen Biotech | Bio-Thera Solutions / Accord BioPharma | Bio-Thera Solutions / Accord BioPharma |
| FDA approval | 2009 | 2013 | May 2026 | May 2026 |
| Interchangeable | — | — | Yes (RA, UC) | Yes (RA) |
| Route | Subcutaneous injection | Intravenous infusion | Subcutaneous injection | Intravenous infusion |
| RA (adults, + MTX) | Yes | Yes | Yes | Yes |
| PsA (adults) | Yes | Yes | No | No |
| AS | Yes | Yes | No | No |
| pJIA (age ≥2) | No | Yes | No | No |
| UC (adults) | Yes | No | Yes | No |
| Pediatric UC (≥15 kg) | Yes (approved Oct 2025) | No | No | No |
| HCPCS code | J3590 (unclassified) | J1602 | Pending | Pending |
| Benefit channel | Pharmacy benefit | Medical benefit | Pharmacy benefit | Medical benefit |
Pharmacy vs medical benefit split
Golimumab is one of the clearest examples of a drug that splits across benefit channels by route:
Simponi SC → Pharmacy benefit. Subcutaneous golimumab is a patient self-administered injection. Most payers cover Simponi under the pharmacy benefit, dispensed through a specialty pharmacy. Florida Blue explicitly states that Simponi "has been deemed appropriate for self-administration or administration by a caregiver (i.e., not a healthcare professional)" and that coverage in a provider-administered setting is not considered medically necessary.
Simponi Aria IV → Medical benefit. Intravenous golimumab requires a 30-minute infusion administered by a healthcare professional. It is billed under the medical benefit using HCPCS J1602 (injection, golimumab, 1 mg, for intravenous use).
This split means that switching a patient from Simponi Aria IV to Simponi SC (or to Immgolis SC) involves a benefit-channel change — from medical to pharmacy. The prior authorization, formulary, and specialty pharmacy requirements will differ.
HCPCS coding
| Code | Description | Product |
|---|---|---|
| J1602 | Injection, golimumab, 1 mg, for intravenous use | Simponi Aria IV |
| J3590 | Unclassified biologics | Simponi SC (some payers) |
| Pending | — | Immgolis SC |
| Pending | — | Immgolis Intri IV |
For a typical 80 kg RA patient receiving Simponi Aria 2 mg/kg (160 mg dose): bill J1602 × 160 units. Each 4 mL vial of Simponi Aria contains 50 mg golimumab, so a 160 mg dose requires 4 vials.
The administration code for Simponi Aria IV is CPT 96413 (chemotherapy infusion) or 96365 (IV infusion for therapy), depending on payer policy. The 30-minute infusion time is shorter than most biologics.
For Simponi SC on the pharmacy benefit, no J-code is used on a medical claim; instead the drug is processed through the pharmacy claim adjudication system using NDC codes.
FDA approval and interchangeability
The FDA approved Immgolis and Immgolis Intri on May 15, 2026. Key points:
- Interchangeability for RA and UC: Immgolis (SC) is interchangeable for RA and UC. Immgolis Intri (IV) is interchangeable for RA.
- Totality of evidence: FDA approval was based on comprehensive analytical, nonclinical, and clinical data demonstrating biosimilarity, including extensive physicochemical testing and biological assays.
- First golimumab biosimilars: These are the first FDA-approved biosimilars for both Simponi and Simponi Aria.
The interchangeability designation means that, under state pharmacy practice laws, a pharmacist may substitute Immgolis for Simponi at the dispensing counter without contacting the prescriber, where permitted by state law and payer policy.
Janssen's litigation and launch timing
Janssen filed BPCIA litigation against Accord BioPharma and Bio-Thera in the U.S. District Court for the District of Delaware on March 3, 2026. On May 6, 2026, Janssen filed a motion for a preliminary injunction to block the launch of Immgolis and Immgolis Intri.
Accord BioPharma's responsive brief is due June 8, 2026. Accord has stated plans to make both products available in Q4 2026, but this timeline depends on the litigation outcome.
For access teams: until the injunction motion is resolved and launch occurs, Simponi and Simponi Aria remain the only golimumab products on the U.S. market. Planning for biosimilar switching should begin now but execution depends on launch confirmation.
Dosing and administration
| Product | Indication | Dose | Frequency |
|---|---|---|---|
| Simponi SC | RA, PsA, AS | 50 mg SC | Once monthly |
| Simponi SC | UC (≥40 kg) | 200 mg SC initial, then 100 mg SC at Week 2 | 100 mg SC every 4 weeks maintenance |
| Simponi SC | Pediatric UC (15–<40 kg) | 100 mg SC initial, then 50 mg SC at Week 2 | 50 mg SC every 4 weeks maintenance |
| Simponi Aria IV | RA, PsA, AS (adults) | 2 mg/kg IV over 30 min | Weeks 0, 4, then every 8 weeks |
| Simponi Aria IV | pJIA, pediatric PsA | 80 mg/m² IV | Weeks 0, 4, then every 8 weeks |
The efficacy and safety of switching between IV and SC formulations have not been established. Patients on Simponi Aria IV cannot simply convert to Simponi SC at an equivalent dose.
Payer coverage and step therapy
Golimumab is a TNF inhibitor positioned within the biologic step-therapy ladder for rheumatology. Typical payer requirements:
UnitedHealthcare (commercial, effective October 2025):
- RA: Trial and inadequate response to at least one conventional DMARD (methotrexate, hydroxychloroquine, sulfasalazine, or leflunomide), plus trial of at least one biologic or targeted synthetic DMARD (adalimumab, golimumab, upadacitinib, tofacitinib). Prescribed by or in consultation with a rheumatologist. Initial authorization for no more than 12 months.
- AS: Documentation of inadequate response to at least two NSAIDs over at least two months, plus trial of Humira, Enbrel, or Cosentyx. Updated 2026 policy adds Bimzelx (bimekizumab) to the list of prior systemic targeted immunomodulators.
- Continuation requires documentation of positive clinical response and appropriate dosing.
Florida Blue (BCBS):
- Simponi SC covered under pharmacy benefit with self-administration deemed appropriate. Provider-administered settings not medically necessary.
- Simponi Aria IV covered under medical benefit with specialist prescribing required.
- Step therapy: for RA, documentation of inadequate response to conventional DMARDs. For PsA, trial of at least two DMARDs. For AS, trial of at least two NSAIDs.
Molina Healthcare (effective December 2025):
- Policy C10422-A covers both Simponi and Simponi Aria.
- Simponi SC: pharmacy benefit, patient self-administered.
- Simponi Aria IV: medical or pharmacy benefit, administered in non-hospital facility.
- Step therapy and diagnosis-specific criteria apply.
Blue Cross Blue Shield of Michigan (effective February 2026):
- Transitioning Simponi Aria members from medical benefit to Simponi SC under pharmacy benefit for most diagnoses, except pediatric PsA and pJIA which remain on medical benefits.
- Proactive authorizations for Simponi SC on pharmacy benefits from February 1, 2026, through January 31, 2027.
- Filling restricted to Walgreens Specialty Pharmacy.
Pediatric UC expansion
On October 7, 2025, the FDA approved a label expansion for Simponi SC to treat pediatric patients weighing at least 15 kg with moderate to severe active UC. The approval was based on the pediatric PURSUIT 2 study, which found 32% of patients achieved clinical remission by Week 6. Among those in clinical remission at Week 6, 57% maintained remission at Week 54. Immgolis does not yet carry this pediatric indication.
Safety profile
Simponi, Simponi Aria, Immgolis, and Immgolis Intri each carry a boxed warning for serious infections and malignancy, consistent with the TNF inhibitor class. Key safety considerations:
- Serious infections including tuberculosis, bacterial, invasive fungal, viral, and other opportunistic infections.
- Lymphoma and other malignancies have been reported in patients treated with TNF blockers.
- Hepatosplenic T-cell lymphoma (HSTCL) risk in patients treated with TNF blockers, particularly adolescent and young adult males with Crohn's disease or UC.
- Latent TB testing before initiation; if positive, start TB treatment before golimumab.
- Not recommended in combination with other biologic DMARDs.
Key takeaways for access teams
- Immgolis/Immgolis Intri are approved but not yet launched. Janssen's injunction motion could delay Q4 2026 availability. Monitor the Delaware litigation docket.
- SC and IV products are on different benefit channels. Simponi SC (and Immgolis SC) route through pharmacy benefit; Simponi Aria IV (and Immgolis Intri IV) route through medical benefit with J1602. Switching between routes changes the entire PA and billing pathway.
- Interchangeability applies to RA and UC only. PsA, AS, and pJIA are not included in the interchangeable designation. Prescriber intent is required for these indications.
- Pediatric UC is a Simponi-only indication for now. The October 2025 label expansion for pediatric UC applies to Simponi SC only. Immgolis does not yet carry this indication.
- Plan for BCBS Simponi Aria-to-Simponi SC transitions. Several BCBS plans are proactively moving Simponi Aria IV patients to Simponi SC on the pharmacy benefit. Access teams should verify that new pharmacy-benefit authorizations are active before medical-benefit authorizations expire.
Sources
- FDA. FDA Approves First Interchangeable Biosimilars to Simponi and Simponi Aria. May 2026. https://www.fda.gov/drugs/news-events-human-drugs/fda-approves-first-interchangeable-biosimilars-simponi-and-simponi-aria-golimumab-treat-rheumatoid
- FDA. Biosimilar Product Information. https://www.fda.gov/drugs/biosimilars/biosimilar-product-information
- Big Molecule Watch. FDA Approves First Interchangeable Biosimilars to Simponi and Simponi Aria; Janssen Seeks Preliminary Injunction. May 2026. https://www.bigmoleculewatch.com/2026/05/22/fda-approves-first-interchangeable-biosimilars-to-simponi-and-simponi-aria-janssen-seeks-a-preliminary-injunction-to-block-their-launch
- Accord BioPharma. FDA Approves IMMGOLIS and IMMGOLIS INTRI. PR Newswire, May 2026. https://www.prnewswire.com/news-releases/fda-approves-immgolis-golimumab-sldi-and-immgolis-intri-golimumab-sldi-first-biosimilars-to-simponi-golimumab-and-simponi-aria-golimumab-accord-biopharma-to-lead-us-commercialization-302774328.html
- UnitedHealthcare. Simponi Aria (Golimumab) Injection for IV Infusion. Commercial Medical Benefit Drug Policy. https://www.uhcprovider.com/content/dam/provider/docs/public/policies/comm-medical-drug/simponi-aria-golimumab-injection-intravenous-infusion.pdf
- Aetna. Golimumab (Simponi and Simponi Aria). Clinical Policy Bulletin 0790. https://www.aetna.com/cpb/medical/data/700_799/0790.html
- Florida Blue. Golimumab (Simponi, Simponi Aria) Coverage Policy. http://mcgs.bcbsfl.com/MCG?mcgId=09-J1000-11
- Molina Healthcare. Simponi/Simponi Aria (golimumab) Coverage Guideline C10422-A. https://www.molinahealthcare.com/
- BCBS Michigan. Simponi Aria Management Change Alert. https://providerinfo.bcbsm.com/documents/alerts/2025/202510/alert-20251030-changing-simponi-aria-comm-members-feb-01.pdf
- Health Net. Golimumab (Simponi, Simponi Aria) Clinical Policy CP.PHAR.253. https://www.healthnet.com/content/dam/centene/policies/pharmacy-policies/phar/CP.PHAR.253.pdf
- PayerPrice. HCPCS J1602 Fee Schedule. https://payerprice.com/rates/J1602-HCPCS-fee-schedule
