InfliximabInflectra
Multiple indications including rheumatoid arthritis, psoriatic arthritis, Crohn's disease in adults and children (6 to 17 years), refractory Crohn's disease, ankylosing spondylitis, psoriasis, and ulcerative colitis in adults and children (6 to 17 years).
Decisions on record
- Meeting Jul 2025 Recommended Rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis, psoriasis, Crohn disease, fistulising Crohn disease, ulcerative colitis
- Meeting Mar 2025 Recommended Rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis, psoriasis, Crohn disease, ulcerative colitis
- Meeting Mar 2025 Recommended Rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis, psoriasis, Crohn disease, ulcerative colitis
- Meeting Nov 2024 Noted Rheumatoid arthritis no PSD
- Meeting Nov 2022 Recommended Severe active rheumatoid arthritis
- Meeting Mar 2022 Recommended Ankylosing spondylitis, psoriatic arthritis, chronic plaque psoriasis, refractory fistulising Crohn disease
- Meeting May 2021 Noted Transition from acute severe ulcerative colitis to moderate to severe ulcerative colitis no PSD
- Meeting Nov 2020 Recommended Rheumatoid arthritis Ankylosing spondylitis Psoriatic arthritis Chronic plaque psoriasis Crohn’s disease Complex refractory fistulising Crohn disease Ulcerative colitis
14 earlier decisions
- Mar 2019 Recommended Crohn disease Fistulating Crohn disease Ulcerative colitis Ankylosing spondylitis Psoriatic arthritis Chronic plaque psoriasis
- Nov 2017 Recommended Multiple indications
- Nov 2016 Recommended Same as currently PBS subsidised indications for infliximab
- Jul 2015 Recommended Ankylosing spondylitis, Crohn's disease, Psoriatic arthritis, Rheumatoid Arthritis, Plaque psoriasis, Ulcerative colitis
- Jul 2014 Recommended 100 mg powder for injection Remicade® Janssen-Cilag Pty Ltd Change to listing (Minor submission) Ulcerative colitis To provide a revised best estimate of the ICER of infliximab versus best supportive care following the March 2014 PBAC recommendation to extend the listing of infliximab to include tr
- Jul 2014 Deferred Indication not stated
- Mar 2014 Recommended Remicade® Janssen-Cilag Pty Ltd Ulcerative Colitis To request Section 100 Highly Specialised Drugs Program (HSD) listing for the treatment of moderate to severe ulcerative colitis in patients who have failed to respond to conventional therapy and meet certain criteria. Approximately 26 more patients
- Nov 2013 Recommended 100 mg, injection, vial Remicade® Janssen-Cilag Pty Ltd Major submission Acute, severe ulcerative colitis, Resubmission to request a Section 100 (Highly Specialised Drugs Program) Authority Required listing for the treatment of acute, severe ulcerative colitis, not responding to IV corticosteroids,
- Mar 2010 Recommended Monoclonal antibody for use in Crohn disease and other chronic inflammatory disease
- Jul 2008 Not recommended Rheumatoid arthritis
- Nov 2007 Recommended Biological disease modifying anti-rheumatic drug no PSD
- Mar 2007 Recommended Crohn’s disease
- Jul 2004 Recommended Used to treat inflammatory diseases, such ankylosing spondylitis, rheumatoid arthritis and Crohn's disease no PSD
- Mar 2003 Recommended Used to treat rheumatoid arthritis and Crohn's disease no PSD
Access path
- TGA registered · Inflectra
TGA label equal than the PBS population
- Mar 2006Recommended
Evidence: RCT → Meta-analysis
- Mar 2006Recommended · restricted
Evidence: RCT → Meta-analysis
- Jul 2006Recommended · restricted
Comparator changed: etanercept → efalizumab
- Mar 2007Recommended · restricted
Comparator changed: efalizumab → placebo
- Jul 2007Recommended · restricted
ICER dropped $75,000 → $45,000 (-40%)
- Jul 2007Recommended · restricted
ICER dropped $75,000 → $45,000 (-40%)
- Jul 2008Recommended
Comparator changed: placebo → etanercept, adalimumab, rituximab
- Mar 2010Recommended · restricted
Comparator changed: etanercept, adalimumab, rituximab → placebo
- Mar 2010Recommended · restricted
Comparator changed: etanercept, adalimumab, rituximab → placebo
- Mar 2013Not recommended
comparator should have included cyclosporin, limited evidence base restricted to small number of acute severe colitis…
- ↻ resubmittedNov 2013Recommended · restricted
Comparator changed: best supportive care (BSC) → best supportive care; cyclosporin
- Mar 2014Recommended · restricted
Comparator changed: best supportive care; cyclosporin → placebo plus best supportive care
- Jul 2014Recommended · restricted
Comparator changed: placebo plus best supportive care → best supportive care
- Jul 2015Recommended · restricted
Comparator changed: best supportive care → Remicade (infliximab)
- Nov 2016Recommended
Comparator changed: Remicade (infliximab) → Remicade (infliximab reference product)
- Nov 2017Recommended · restricted
Evidence: RCT → Other
- Mar 2019Recommended · restricted
Evidence: Other → Cost-minimisation
- Nov 2020Recommended · restricted
Evidence: Cost-minimisation → RCT
- Mar 2022Recommended · restricted
Comparator changed: infliximab intravenous (IFX IV) → infliximab intravenous
- Nov 2022Recommended · restricted
Comparator changed: infliximab intravenous → infliximab IV induction
- Mar 2025Recommended · restricted
Comparator changed: infliximab IV induction → Inflectra and Renflexis (existing…
- Mar 2025Recommended · restricted
Comparator changed: infliximab IV induction → Inflectra and Renflexis (existing…
- Jul 2025Recommended · restricted
- PBS listing · Authority Required
From the public summary
5.1 The PBAC recommended Section 100 (Highly Specialised Drugs Program) Authority Required listings of a new infliximab biosimilar (Remsima®) on a cost-minimisation basis and under the same circumstances as the existing PBS-listed biosimilar brands of infliximab 100 mg powder for injection (Inflectra® and Renflexis®), for the same indications.PSD · Jul 2025
5.2 The PBAC advised the equi-effective doses to be 1 mg of Remsima = 1 mg of Remicade (and/or other brands of PBS-listed infliximab).PSD · Jul 2025
5.9 As a Category 3 submission, the economic analysis has not been independently evaluated.PSD · Nov 2022
5.10 The submission presented a cost-minimisation approach of IFX SC loading doses compared with IFX IV induction doses over the first 6 weeks of treatment. The equi- effective doses were estimated as IFX SC 120 mg at weeks 0, 1, 2, 3, and 4, and IFX IV 3 mg/kg at weeks 0 and 2. 4PSD · Nov 2022
5.7 The submission claimed non-inferior comparative effectiveness and safety of IFX SC loading doses compared with IFX IV induction doses.PSD · Nov 2022
5.8 The PBAC noted no clinical data was presented; however considered that, overall, the claim of non-inferior comparative effectiveness and safety was likely to be reasonable.PSD · Nov 2022
4.2 The PBAC noted and welcomed the input from Crohn’s and Colitis Australia (CCA) via the Consumer Comments facility on the PBS website. CCA supported the PBS listing of Remsima, stating that infliximab provides an important treatment option for people with Crohn’s disease who have not responded to other treatments.PSD · Jul 2025
6.35 The sponsor did not propose any risk sharing arrangements..PSD · Nov 2016
Cost-effectiveness
Cost-minimisation analysis; no ICER calculated as Remsima is a biosimilar with equi-effective dosing (1 mg Remsima = 1 mg Remicade) and expected to have nil financial impact through substitution.
The PBAC considered that the listing of Remsima would not result in a net cost to the PBS as it would likely substitute for the other brands of infliximab 100 mg powder for injection and not increase the overall market utilisation. PBAC · 2025
Decision context
PopulationPatients with rheumatoid arthritis, psoriatic arthritis, Crohn's disease (adults and children aged 6–17 years), refractory Crohn's disease, ankylosing spondylitis, psoriasis, and ulcerative colitis (adults and children aged 6–17 years) — same indications as other PBS-listed infliximab biosimilars.
Submission history
| Decided | Outcome | Comparator | ICER | Evidence |
|---|---|---|---|---|
| Jul 2025 | Recommended · restricted | other brands of infliximab 100 mg powder for injection (Inflectra, Renflexis, Remicade) | — | Other |
| Mar 2025 | Recommended · restricted | Inflectra and Renflexis (existing infliximab biosimilars) | — | Registry |
| Mar 2025 | Recommended · restricted | — | — | — |
| Nov 2022 | Recommended · restricted | infliximab IV induction | — | Single-arm · Cost-minimisation |
| Mar 2022 | Recommended · restricted | infliximab intravenous | — | Single-arm · Cost-minimisation |
| Nov 2020 | Recommended · restricted | infliximab intravenous (IFX IV) | — | RCT · Other |
| Mar 2019 | Recommended · restricted | — | — | Cost-minimisation · Cost-minimisation |
| Nov 2017 | Recommended · restricted | — | — | Other |
| Nov 2016 | Recommended | Remicade (infliximab reference product) | — | RCT · ACR20 |
| Jul 2015 | Recommended · restricted | Remicade (infliximab) | — | RCT · Pharmacokinetic equivalence and therapeutic equivalence (ACR20) |
| Jul 2014 | Recommended · restricted | best supportive care | $45k–75k | RCT · Remission |
| Mar 2014 | Recommended · restricted | placebo plus best supportive care | — | RCT · Remission |
| Nov 2013 | Recommended · restricted | best supportive care; cyclosporin | — | RCT · Colectomy avoidance |
| Mar 2013 | Not recommended | best supportive care (BSC) | $75k–700k | RCT · Colectomy avoidance, clinical remission |
| Mar 2010 | Recommended · restricted | placebo | $45k–75k | RCT · Other |
| Mar 2010 | Recommended · restricted | placebo | $45k–75k | RCT · time to loss of response |
| Jul 2008 | Recommended | etanercept, adalimumab, rituximab | — | RCT, Single-arm, Registry · ACR20 response rate |
| Jul 2007 | Recommended · restricted | placebo as add on to immunosuppressive agents | $15k–45k | RCT · response at week 10, remission and response rates at week 54 |
| Jul 2007 | Recommended · restricted | placebo | $15k–45k | RCT · PCDAI-response |
| Mar 2007 | Recommended · restricted | placebo | $45k–75k | RCT · QoL, Remission (CDAI ≤ 150) |
| Jul 2006 | Recommended · restricted | efalizumab | $45k–75k | RCT, Bayesian meta-analysis · PASI 75 response |
| Mar 2006 | Recommended | etanercept | — | RCT · ACR 50 |
| Mar 2006 | Recommended · restricted | etanercept | — | Meta-analysis · ACR50 |
Clinical evidence
| Trial | Phase | N | Primary outcome | Status |
|---|---|---|---|---|
| CYSIF (Laharie et al. 2012) | Ph 4 | 115 | % of patients with treatment failure defined as: absence of clinical response at D7 or abs… | completed |
| NCT02096861 | Ph 3 | 220 | The Number and Percentage of Patients Achieving Clinical Response According to Crohn's Dis… | completed |
| NCT02452151 | Ph 4 | 300 | Relapse rate | unknown |
| NOR-SWITCH | Ph 4 | 482 | Occurrence of disease worsening | completed |
Consumer voice
Crohn's and Colitis Australia supported PBS listing of Remsima, noting that infliximab provides an important treatment option for people with Crohn's disease who have not responded to other treatments, and welcomed the addition of biosimilar versions where clinically equivalent.
infliximab provides an important treatment option for people with Crohn's disease who have not responded to other treatments Consumer comments · PSD
Similar precedents
Regulatory · TGA
Label equal than PBS population — PBAC-recommended indications are identical to TGA-registered label across all conditions and age groups.