AdalimumabAbrilada
Treatment of multiple autoimmune conditions including severe Crohn disease, moderate to severe ulcerative colitis, severe active rheumatoid arthritis, severe psoriatic arthritis, ankylosing spondylitis, severe chronic plaque psoriasis, moderate to severe hidradenitis suppurativa, severe active juvenile idiopathic arthritis, and vision-threatening non-infectious uveitis.
Decisions on record
- Meeting Mar 2026 Recommended Crohn disease, ulcerative colitis, active juvenile idiopathic arthritis, complex refractory fistulising Crohn disease, active rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, chronic plaque psoriasis, hidradenitis suppurativa
- Meeting Mar 2026 Recommended Moderate to severe ulcerative colitis, severe juvenile idiopathic arthritis, severe chronic plaque psoriasis, severe Crohn disease, vision-threatening non-infectious uveitis
- Meeting Jul 2025 Recommended Paediatric chronic plaque psoriasis and enthesitis/spondylitis related juvenile idiopathic arthritis no PSD
- Meeting Dec 2024 Recommended Enthesitis/spondylitis related juvenile idiopathic arthritis and chronic plaque psoriasis in paediatric patients; moderate to severe ulcerative colitis; severe Crohn disease; juvenile idiopathic arthritis no PSD
- Meeting Jul 2024 Recommended Severe Crohn disease, moderate to severe ulcerative colitis, severe active juvenile idiopathic arthritis, complex refractory fistulising Crohn disease, severe active rheumatoid arthritis, severe psoriatic arthritis, ankylosing spondylitis, severe chronic plaque psoriasis, moderate to severe hidraden
- Meeting Mar 2024 Recommended Vision-threatening non-infectious uveitis
- Meeting Mar 2024 Deferred Immune-mediated inflammatory disease (IMID) in paediatric patients
- Meeting Mar 2024 Recommended Complex refractory fistulising Crohn disease, ulcerative colitis, chronic plaque psoriasis, hidradenitis suppurativa
41 earlier decisions
- Nov 2023 Recommended Severe Crohn disease, moderate to severe ulcerative colitis, severe active juvenile idiopathic arthritis, complex refractory fistulising Crohn disease, severe active rheumatoid arthritis, severe psoriatic arthritis, ankylosing spondylitis, severe chronic plaque psoriasis, moderate to severe hidraden
- Jul 2023 Recommended Severe Crohn disease, moderate to severe ulcerative colitis, severe active juvenile idiopathic arthritis, complex refractory fistulising Crohn disease, severe active rheumatoid arthritis, severe psoriatic arthritis, ankylosing spondylitis, severe chronic plaque psoriasis, moderate to severe hidraden
- Jul 2023 Noted Crohn disease, Ulcerative colitis, Juvenile idiopathic arthritis, Rheumatoid arthritis, Psoriatic arthritis, Ankylosing spondylitis, Plaque psoriasis, Hidradenitis suppurativa
- Nov 2022 Not recommended Multiple indications (rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis and others)
- Jul 2022 Recommended Severe Crohn disease, moderate to severe ulcerative colitis, severe active juvenile idiopathic arthritis, complex refractory fistulising Crohn disease, severe active rheumatoid arthritis, severe psoriatic arthritis, ankylosing spondylitis, severe chronic plaque psoriasis, moderate to severe hidraden
- Nov 2021 Recommended Severe Crohn disease; Moderate to severe ulcerative colitis; Severe active juvenile idiopathic arthritis; Complex refractory fistulising Crohn disease; Severe active rheumatoid arthritis; Severe psoriatic arthritis; Ankylosing spondylitis; Severe chronic plaque psoriasis; Moderate to severe hidraden
- Nov 2021 Recommended Severe Crohn disease; Moderate to severe ulcerative colitis
- Jul 2021 Recommended Crohn disease, ulcerative colitis, juvenile idiopathic arthritis, rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, plaque psoriasis, hidradenitis suppurativa
- Dec 2020 Not recommended Severe Crohn disease; complex refractory fistulising Crohn disease; moderate to severe ulcerative colitis; severe active juvenile idiopathic arthritis; adult patients with a history of juvenile idiopathic arthritis; severe psoriatic arthritis; ankylosing spondylitis; severe chronic plaque psoriasis;
- Nov 2020 Recommended Severe Crohn disease; moderate to severe ulcerative colitis; Severe active juvenile idiopathic arthritis; Complex refractory fistulising Crohn disease; Severe active rheumatoid arthritis; Severe psoriatic arthritis; Ankylosing spondylitis; Severe chronic plaque psoriasis; Moderate to severe hidraden
- Nov 2020 Deferred Severe Crohn disease; complex refractory fistulising Crohn disease; moderate to severe ulcerative colitis; severe active juvenile idiopathic arthritis; adult patients with a history of juvenile idiopathic arthritis; severe psoriatic arthritis; ankylosing spondylitis; severe chronic plaque psoriasis;
- Jul 2020 Recommended Severe active rheumatoid arthritis Severe psoriatic arthritis Ankylosing spondylitis Severe chronic plaque psoriasis Juvenile idiopathic arthritis Severe Crohn’s disease Refractory fistulising Crohn’s disease Moderate to severe hidradenitis suppurativa
- Mar 2020 Recommended Crohn disease Ulcerative colitis Juvenile idiopathic arthritis Fistulising Crohn disease Rheumatoid arthritis Psoriatic arthritis Ankylosing spondylitis Chronic plaque psoriasis Hidradenitis suppurativa
- Nov 2019 Recommended Moderate to severe hidradenitis suppurativa (HS)
- Jul 2018 Recommended Severe active rheumatoid arthritis; Sever psoriatic arthritis; Ankylosing spondylitis; Severe chronic plaque psoriasis; Sever active juvenile idiopathic arthritis; Sever Crohn disease; Refractory fistulating Crohn disease; Moderate to severe ulcerative colitis; Moderate to severe hidradenitis suppur
- Jul 2018 Recommended Severe active rheumatoid arthritis; Severe psoriatic arthritis; Ankylosing spondylitis; Severe chronic plaque psoriasis; Severe active juvenile idiopathic arthritis; Severe Crohn disease; Refractory fistulating Crohn disease; Moderate to severe ulcerative colitis; Moderate to severe hidradenitis sup
- Jul 2018 Recommended Severe active rheumatoid arthritis (RA)
- Dec 2017 Recommended All current subsidised indications of adalimumab on the PBS
- Jul 2017 Recommended Same as currently PBS subsidised indications for adalimumab
- Mar 2017 Not recommended Non-infectious intermediate, posterior or panuveitis uveitis (inflammatory disease of the eye)
- Dec 2016 Recommended Hidradenitis suppurativa (HS) no PSD
- Nov 2016 Deferred Hidradenitis suppurativa (HS)
- Nov 2016 Noted Ulcerative Colitis (UC)
- Jul 2016 Not recommended Adalimumab is indicated for reducing signs and symptoms in moderate to severe rheumatoid arthritis, polyarticular juvenile idiopathic arthritis, enthesitis-related arthritis, psoriatic arthritis, Crohn’s Disease, ulcerative colitis, chronic plaque psoriasis, active ankylosing spondylitis and hidrade
- Mar 2016 Recommended Ulcerative colitis
- Mar 2016 Not recommended Hidradenitis suppurativa
- Nov 2015 Not recommended Adalimumab is indicated for reducing signs and symptoms in moderate to severe rheumatoid arthritis, polyarticular juvenile idiopathic arthritis, psoriatic arthritis, Crohn’s Disease, ulcerative colitis, chronic plaque psoriasis and active ankylosing spondylitis.
- Jul 2015 Not recommended Adalimumab is indicated for reducing signs and symptoms in moderate to severe rheumatoid arthritis, polyarticular juvenile idiopathic arthritis, psoriatic arthritis, Crohn’s Disease, ulcerative colitis, chronic plaque psoriasis and active ankylosing spondylitis.
- Nov 2014 Recommended 20 mg/0.4 mL injection, 2 x 0.4 mL syringes 40 mg/0.8 mL injection, 2 x 0.8 mL cartridges 40 mg/0.8 mL injection, 2 x 0.8 mL syringes 40 mg/0.8 mL injection, 6 x 0.8 mL cartridges 40 mg/0.8 mL injection, 6 x 0.8 mL syringes Humira® AbbVie Pty Ltd Change to listing (Major submission) Paediatric Crohn
- Jul 2014 Not recommended Change to listing. (Major submission) Patients who have had an inadequate response to conventional therapy or who are intolerant to or have medical contraindications for such therapies. Patients should show a clinical response within 8 weeks for treatment to continue treatment beyond that time Treat
- Nov 2013 Not recommended AbbVie Pty Ltd Ulcerative colitis Authority Required listing for the treatment of adult patients with moderate to severe active ulcerative colitis. Based on the trial data presented in the submission, the PBAC considered that adalimumab treatment was associated with a real but modest clinical benefi
- Nov 2010 Recommended Crohn disease
- Mar 2010 Recommended Juvenile arthritis
- Mar 2009 Recommended Chronic plaque psoriasis
- Dec 2008 Recommended Psoriatic arthritis no PSD
- Jul 2008 Not recommended Chronic plaque psoriasis
- Nov 2007 Recommended Crohn disease
- Nov 2007 Recommended Biological disease modifying anti-rheumatic drug
- Mar 2007 Recommended Rheumatoid arthritis, ankylosing spondylitis, and psoriatic arthritis no PSD
- Nov 2006 Recommended Ankylosing spondylitis
- Jul 2004 Recommended Used to treat rheumatoid arthritis. no PSD
Access path
- TGA registered · Abrilada
TGA label narrower than the PBS population
- Mar 2006Recommended · restricted
vs etanercept
- Mar 2006Recommended · restricted
- Nov 2006Recommended · restricted
- Nov 2007Recommended · restricted
Comparator changed: etanercept → infliximab
- Nov 2007Recommended · restricted
Comparator changed: etanercept → infliximab
- Jul 2008Not recommended
uncertain clinical effectiveness against efalizumab (no long-term comparative durability data presented), uncertain…
- Jul 2008Not recommended
uncertain clinical effectiveness, uncertain cost-effectiveness versus efalizumab, inability to reach firm conclusion on…
- ↻ resubmittedMar 2009Recommended · restricted
Comparator changed: efalizumab (primary); infliximab (secondary) → efalizumab (primary)…
- Mar 2010Recommended · restricted
Comparator changed: efalizumab (primary); etanercept (main comparator due to similar…
- Nov 2010Recommended · restricted
Comparator changed: etanercept → infliximab
- Mar 2013Not recommended
highly uncertain cost-effectiveness, inappropriate utility values (excessive incremental utility gain of 0.37 compared…
- Nov 2013Not recommended
Economic analysis highly uncertain and unreliable, model structure inappropriate with costs not linked to health…
- Jul 2014Not recommended
Comparator changed: standard care (corticosteroids, 5-ASA, immunosuppressants) → best…
- ↻ resubmittedNov 2014Recommended · restricted
Comparator changed: best supportive care → infliximab
- Jul 2015Not recommended
Listing: Restricted → Authority Required
- Nov 2015Not recommended
evidence did not establish non-inferiority of adalimumab to infliximab, low certainty of indirect comparisons…
- Mar 2016Not recommended
Comparator changed: infliximab → best supportive care (placebo)
- ↻ resubmittedMar 2016Recommended
Comparator changed: infliximab → best supportive care (placebo)
- Jul 2016Not recommended
Comparator changed: infliximab → best supportive care (placebo)
- Nov 2016Deferred
- Mar 2017Not recommended
Comparator changed: best supportive care (placebo) → current standard of care (consisting…
- ↻ resubmittedJul 2017Recommended
Evidence: RCT → Cost-minimisation
- Dec 2017Recommended
Evidence: Cost-minimisation → RCT
- Jul 2018Recommended
Comparator changed: adalimumab 40 mg/0.8 mL → adalimumab (Humira)
- Jul 2018Recommended · restricted
Comparator changed: adalimumab 40 mg/0.8 mL → adalimumab (Humira)
- Jul 2018Recommended · restricted
Comparator changed: adalimumab 40 mg/0.8 mL → adalimumab (Humira)
- Jul 2018Recommended
Comparator changed: adalimumab 40 mg/0.8 mL → adalimumab (Humira)
- Nov 2019Recommended
Comparator changed: Humira (reference adalimumab biological) → adalimumab 40 mg weekly
- Nov 2019Recommended
Comparator changed: Humira (reference adalimumab biological) → adalimumab 40 mg weekly
- Mar 2020Recommended
Comparator changed: adalimumab 40 mg weekly → Humira (adalimumab reference brand)
- Jul 2020Recommended
Comparator changed: Humira (adalimumab reference brand) → Humira (adalimumab reference…
- Nov 2020Recommended · restricted
Comparator changed: Humira (adalimumab reference biologic) → Humira (reference brand…
- Dec 2020Not recommended
Complex restrictions require full written assessment; treatment failure exemption falls outside biosimilar uptake…
- ↻ resubmittedJul 2021Recommended · restricted
Evidence: Other → RCT
- Nov 2021Recommended · restricted
Comparator changed: Humira (reference adalimumab brand) → Humira (reference biologic…
- Nov 2021Recommended · restricted
Comparator changed: Humira (reference adalimumab brand) → Humira (reference biologic…
- Jul 2022Recommended · restricted
Comparator changed: two adalimumab 40 mg injections administered by subcutaneous…
- Nov 2022Not recommended
Proposed changes do not align with the Government's biosimilar policy; the PBAC was mindful of supporting the…
- ↻ resubmittedJul 2023Recommended · restricted
- Nov 2023Recommended · restricted
Comparator changed: Humira → Humira (adalimumab reference brand)
- Mar 2024Recommended · restricted
Comparator changed: Humira (adalimumab reference brand) → best supportive care: high dose…
- Mar 2024Recommended · restricted
Comparator changed: Humira (adalimumab reference brand) → best supportive care: high dose…
- Jul 2024Recommended · restricted
Comparator changed: Humira (adalimumab reference biologic) → Humira (reference brand) and…
- Dec 2024Recommended · restricted
Evidence: RCT → Other
- Jul 2025Recommended · restricted
- Mar 2026Recommended · restricted
Evidence: Other → Cost-minimisation
- Mar 2026Recommended · restricted
Evidence: Other → Cost-minimisation
- PBS listing · Authority Required
From the public summary
6.1 The PBAC recommended the Authority Required listing of adalimumab (Yuflyma) in the form of 20 mg in 0.2 mL pre-filled syringe (PFS) under the same circumstances as the PBS--listed reference biologic Humira 20 mg in 0.2 mL PFS and more specifically, the biosimilar brand Amgevita 20 mg in 0.4mL PFS for the following indications and treatment phases:PSD · Mar 2026
• moderate to severe ulcerative colitis for treatment phases in o first continuing o continuing o balance of supplyPSD · Mar 2026
5.7 As a Category 4 submission, the economic analysis has not been independently evaluated.PSD · Mar 2026
5.8 The submission presented a cost-minimisation approach of Yuflyma compared with Humira. The equi-effective doses presented in the submission were 1 mg of adalimumab in Yuflyma 20 mg in 0.2 mL = 1 mg of adalimumab in Yuflyma 40 mg in 0.4 mL = 1 mg of adalimumab 20 mg in 0.2 mL (any other brand). It is also noted that the Yuflyma equi-effective doses should be considered with relevant comparator Amgevita 20 mg.PSD · Mar 2026
5.5 The submission claimed non-inferior comparative effectiveness and non-inferior comparative safety for Yuflyma compared with Humira.PSD · Mar 2026
5.6 The submission claimed that ‘On a mg for mg basis the adalimumab in Yuflyma is therapeutically equivalent to the adalimumab (prefilled syringe) of any other brand in terms of both clinical efficacy and safety.’ The approved Product Information stated Yuflyma is biosimilar to Humira.PSD · Mar 2026
6.2 The PBAC noted and welcomed the input from individuals (6), health care professionals (3) and organisations (4) via the Consumer Comments facility on the PBS website. The comments noted the effectiveness of adalimumab for paediatric IMIDs in improving disease symptoms and quality of life, and that it could be easily administered.PSD · Mar 2024
Comments were supportive of the requested listing, stating that it would allow access to adalimumab earlier in the treatment course and lead to better patient outcomes.PSD · Mar 2024
Cost-effectiveness
cost-minimisation basis; no ICER calculated as this is a biosimilar with cost-neutral impact
The PBAC considered that the listing of Amgevita HC 20 mg in 0.2 mL PFS and 40 mg in 0.4 mL PFS 40 mg in 0.4 mL PFP, 80 mg in 0.8 mL PFP, is expected to be cost-neutral to Government given that Amgevita HC will likely substitute for the reference biologic Humira and therefore not increase overall market utilisation. PBAC · 2026
Decision context
PopulationPatients with severe Crohn disease, moderate to severe ulcerative colitis, severe active rheumatoid arthritis, severe psoriatic arthritis, ankylosing spondylitis, severe chronic plaque psoriasis, moderate to severe hidradenitis suppurativa, severe active juvenile idiopathic arthritis, enthesitis/spondylitis related juvenile idiopathic arthritis, complex refractory fistulising Crohn disease, and vision-threatening non-infectious uveitis.
Submission history
| Decided | Outcome | Comparator | ICER | Evidence |
|---|---|---|---|---|
| Mar 2026 | Recommended · restricted | Humira (reference brand adalimumab); Amgevita (biosimilar adalimumab 20 mg in 0.4 mL) | — | Cost-minimisation |
| Mar 2026 | Recommended · restricted | Humira (reference adalimumab brand) | — | Cost-minimisation |
| Jul 2025 | Recommended · restricted | — | — | Other |
| Dec 2024 | Recommended · restricted | — | — | Other |
| Jul 2024 | Recommended · restricted | Humira (reference brand) and other biosimilar brands of adalimumab | — | RCT · Other |
| Mar 2024 | Recommended · restricted | best supportive care: high dose oral corticosteroids (> 7.5 mg/day) with or without an immunomodulatory agent | $25k–35k | RCT · Time to treatment failure (inflammatory uveitic flare) |
| Mar 2024 | Recommended · restricted | Humira (adalimumab reference biologic) | — | Cost-minimisation · Cost-minimisation |
| Nov 2023 | Recommended · restricted | Humira (adalimumab reference brand) | — | Cost-minimisation · Cost-minimisation |
| Jul 2023 | Recommended · restricted | Humira | — | Other · Surrogate |
| Nov 2022 | Not recommended | — | — | Other |
| Jul 2022 | Recommended · restricted | Humira (reference brand adalimumab) | — | RCT · Efficacy and safety (non-inferiority to Humira) |
| Nov 2021 | Recommended · restricted | Humira (reference biologic adalimumab) | — | Single-arm · Safety |
| Nov 2021 | Recommended · restricted | two adalimumab 40 mg injections administered by subcutaneous injection in a pre-filled syringe | — | Cost-minimisation · Cost-minimisation |
| Jul 2021 | Recommended · restricted | Humira (reference adalimumab brand) | — | RCT · Other |
| Dec 2020 | Not recommended | — | — | Other |
| Nov 2020 | Recommended · restricted | Humira (reference brand adalimumab) | — | RCT · PFS |
| Jul 2020 | Recommended | Humira (adalimumab reference biologic) | — | Other · Other |
| Mar 2020 | Recommended | Humira (adalimumab reference brand) | — | Other · PASI-75 |
| Nov 2019 | Recommended | adalimumab 40 mg weekly | — | Single-arm · Surrogate |
| Nov 2019 | Recommended | adalimumab 40 mg weekly | — | Single-arm · Other |
| Jul 2018 | Recommended | adalimumab (Humira) | — | RCT · Equivalence to reference brand (Humira) |
| Jul 2018 | Recommended · restricted | adalimumab 20 mg/0.4 mL PFS (for 20 mg/0.2 mL); adalimumab 40 mg/0.8 mL PFS and cartridges (for 80 mg/0.8 mL) | — | Cost-minimisation · Cost-minimisation |
| Jul 2018 | Recommended · restricted | Adalimumab 20 mg/0.4 mL pre-filled syringe for the 20 mg/0.2 mL form; adalimumab 40 mg/0.8 mL pre-filled syringe and car | — | Other |
| Jul 2018 | Recommended | Humira (reference adalimumab biological) | — | RCT · ACR20 |
| Dec 2017 | Recommended | adalimumab 40 mg/0.8 mL | — | RCT · Surrogate |
| Jul 2017 | Recommended | — | — | Cost-minimisation · Cost-minimisation |
| Mar 2017 | Not recommended | current standard of care (consisting of high dose oral corticosteroids (>7.5mg/day) with or without an immunomodulatory | — | RCT · Other |
| Nov 2016 | Deferred | best supportive care (placebo) | $45k–75k | RCT · HiSCR |
| Jul 2016 | Not recommended | best supportive care (placebo) | — | RCT · HiSCR (Hidradenitis Suppurativa Clinical Response) |
| Mar 2016 | Not recommended | best supportive care (placebo) | — | RCT · HiSCR |
| Mar 2016 | Recommended | infliximab | — | RCT · Remission |
| Nov 2015 | Not recommended | infliximab | — | Meta-analysis · Remission |
| Jul 2015 | Not recommended | infliximab | — | RCT · Remission and response |
| Nov 2014 | Recommended · restricted | infliximab | — | RCT · Remission |
| Jul 2014 | Not recommended | best supportive care | — | RCT · Clinical remission and clinical response |
| Nov 2013 | Not recommended | standard care (corticosteroids, 5-ASA, immunosuppressants) | $45k–75k | RCT |
| Mar 2013 | Not recommended | placebo | $15k–45k | RCT · PASI 75 response |
| Nov 2010 | Recommended · restricted | infliximab | — | RCT · complete fistula closure at week 56 |
| Mar 2010 | Recommended · restricted | etanercept | — | RCT · Disease flare rate |
| Mar 2009 | Recommended · restricted | efalizumab (primary); etanercept (main comparator due to similar administration); infliximab (secondary) | — | RCT, indirect comparison (meta-analysis) · initial PASI 75 response, long-term response |
| Jul 2008 | Not recommended | infliximab (primary); efalizumab (secondary) | — | RCT | Single-arm | Registry |
| Jul 2008 | Not recommended | efalizumab (primary); infliximab (secondary) | — | Meta-analysis · PASI-75 |
| Nov 2007 | Recommended · restricted | infliximab | — | RCT · Clinical remission |
| Nov 2007 | Recommended · restricted | infliximab | — | RCT · CDAI |
| Nov 2006 | Recommended · restricted | etanercept | — | RCT · ASAS 20 response |
| Mar 2006 | Recommended · restricted | etanercept | — | RCT · ACR 20 (at 12 weeks), ACR 50, PsARC, PASI75 |
| Mar 2006 | Recommended · restricted | etanercept | — | RCT · ACR20 |
Consumer voice
Thirteen individuals and organisations (6 individuals, 3 healthcare professionals, 4 organisations) provided input supporting adalimumab for paediatric IMIDs, noting its effectiveness in improving disease symptoms and quality of life, ease of administration, and that current PBS restrictions do not reflect current clinical practice. Comments also highlighted access delays, financial strain on fami
Comments noted the effectiveness of adalimumab for paediatric IMIDs in improving disease symptoms and quality of life, and that it could be easily administered. Consumer comments · PSD
Similar precedents
Regulatory · TGA
Label narrower than PBS population — TGA label covers only vision-threatening non-infectious uveitis; PBAC recommends this plus nine additional disease indications across inflammatory bowel, rheumatologic, and dermatologic conditions.
Listed in law
PBS listings commencing 1 Apr 2021 were made by these 5 determinations under the National Health Act 1953. A determination covers every listing that commenced that day, so this is the legal instrument in force for the date — not a document naming this medicine. Open it and check.
| Determination | Made | Status | |
|---|---|---|---|
| PB 22 of 2021 | 31 Mar 2021 | Repealed | PDF ↗ |
| PB 23 of 2021 | 31 Mar 2021 | Repealed | PDF ↗ |
| PB 24 of 2021 | 31 Mar 2021 | Repealed | PDF ↗ |
| PB 24 of 2021 | 31 Mar 2021 | Repealed | PDF ↗ |
| PB 36 of 2021 | 31 Mar 2021 | Repealed | PDF ↗ |