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The Australian Prescription Medicine Decision Summary provides a short overview of the TGA's evaluation process leading to the registration of a new prescription medicine on the Australian Register of Therapeutic Goods (ARTG).
More in-depth information about the evaluation will be available in the Australian Public Assessment Report (AusPAR) for a particular prescription medicine, which can be found on the AusPAR search page once published.
Australian prescription medicine decision summary
|Submission type|| |
New biosimilar medicine
|Product name|| |
|Active ingredients|| |
|ATC codes|| |
|Date of decision|| |
15 June 2020
|Date of entry onto ARTG|| |
17 June 2020
|ARTG numbers|| |
320241, 320242, 320243
|Black Triangle Scheme|| |
Fresenius Kabi Australia Pty Ltd
|Sponsor address|| |
Level 2, Woodland Way, Mount Kuring-gai, NSW, 2080
|Dose forms|| |
Solution for injection
40 mg / 0.8 mL
|Other ingredients|| |
Monobasic sodium phosphate dehydrate, Dibasic sodium phosphate dehydrate, Mannitol, Sodium chloride, Citric acid monohydrate, Sodium citrate dehydrate, Polysorbate 80, Sodium hydroxide (for pH adjustment), Water for injections
Pre-filled syringe, pre-filled pen, vial
|Pack sizes|| |
2 pre-filled syringes
2 pre-filled pens
|Routes of administration|| |
The recommended dose for adult patients with rheumatoid arthritis is 40 mg administered fortnightly as a single dose.
Juvenile idiopathic arthritis
The recommended dose of Idacio for patients 2 years of age and older with polyarticular juvenile idiopathic arthritis and enthesitis-related arthritis is based on weight:
The recommended dose of Idacio for patients with psoriatic arthritis is 40 mg adalimumab administered fortnightly as a single dose.
The recommended dose of Idacio for patients with ankylosing spondylitis is 40 mg adalimumab administered every fortnight as a single dose.
The recommended Idacio dose regimen for adult patients with Crohn's disease:
Paediatric Crohn's disease (6 to 17 years)
The recommended dose of Idacio for patients from 6 to 17 years of age with Crohn's disease is based on body weight and induction and maintenance phases, as outlined in the Product Information.
The recommended Idacio dose regimen for adult patients is:
The recommended dose of Idacio for adult patients is an initial dose of 80 mg (as two 40 mg injections), followed by 40 mg fortnightly, starting one week after the initial dose.
Paediatric plaque psoriasis (4 to 17 years)
The recommended dose of Idacio is based on body weight:
Doses are administered subcutaneously weekly for the first two doses and fortnightly thereafter.
The recommended Idacio dose regimen for adult patients with hidradenitis suppurativa (HS) is 160 mg initially at Day 1 (given as four 40 mg injections in one day OR as two 40 mg injections per day for two consecutive days), followed by 80 mg two weeks later at Day 15 (given a two 40 mg injections). Two weeks later (Day 29) continue with a dose of 40 mg every week or 80 mg fortnightly.
Adolescents (from 12 years of age, weighing at least 30 kg)
The recommended Idacio dose is 80 mg at Week 0 (given as two 40 mg injections), followed by 40 mg fortnightly, starting at Week 1 via subcutaneous injection.
Ophthalmologists are advised to consult with an appropriate specialist before initiation of treatment with Idacio. Use of Idacio for uveitis should be supervised by an ophthalmologist or other appropriate specialist. Patients treated with Idacio should be given the patient reminder card.
The recommended dose of Idacio for adult patients with uveitis is an initial dose of 80 mg (given as two 40 mg injections), followed by 40 mg fortnightly, starting one week after the initial dose.
For further information on dosage, refer to the Product Information.
|Pregnancy category|| |
Drugs which, owing to their pharmacological effects, have caused or may be suspected of causing, harmful effects on the human fetus or neonate without causing malformations. These effects may be reversible. Accompanying texts should be consulted for further details.
The use of any medicine during pregnancy requires careful consideration of both risks and benefits by the treating health professional. This must not be used as the sole basis of decision making in the use of medicines during pregnancy. The TGA does not provide advice on the use of medicines in pregnancy for specific cases. More information is available from obstetric drug information services in your State or Territory.
Idacio (adalimumab rch) was approved for the following therapeutic use:
Idacio is indicated for reducing signs and symptoms, as well as inhibiting the progression of structural damage in adult patients with moderate to severely active rheumatoid arthritis. This includes the treatment of patients with recently diagnosed moderate to severely active disease who have not received methotrexate.
Idacio can be used alone or in combination with methotrexate.
Juvenile idiopathic arthritis
Polyarticular juvenile idiopathic arthritis
Idacio in combination with methotrexate is indicated for reducing the signs and symptoms of moderately to severely active polyarticular juvenile idiopathic arthritis in patients 2 years of age and older who have had an inadequate response to one or more disease modifying anti-rheumatic drugs (DMARDs). Idacio can be given as monotherapy in case of intolerance to methotrexate or when continued treatment with methotrexate is inappropriate.
Indacio is indicated for the treatment of enthesitis-related arthritis in children, who have had an inadequate response to, or who are intolerant to, conventional therapy.
Idacio is indicated for the treatment of signs and symptoms, as well as inhibiting the progression of structural damage, of moderate to severely active psoriatic arthritis in adult patients where response to previous DMARDs has been inadequate.
Idacio is indicated for reducing signs and symptoms in patients with active ankylosing spondylitis.
Crohn's disease in adults and children (≥ 6 years)
Idacio is indicated for the treatment of moderate to severe Crohn's disease, to reduce the signs of symptoms of the disease and to induce and maintain clinical remission in patients:
- who have had an inadequate response to conventional therapies or,
- who have lost response to or are intolerant to infliximab
Idacio is indicated for the treatment of moderate to severe ulcerative colitis in adult 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 of treatment to continue treatment beyond that time. (see 5.1 Pharmacodynamic Properties-Clinical Trials).
Psoriasis in adults and children
Idacio is indicated for the treatment of moderate to severe chronic plaque psoriasis in adult patients who are candidates for systemic therapy or phototherapy.
Idacio is indicated for the treatment of severe chronic plaque psoriasis in children and adolescent patients from 4 years of age who have had an inadequate response to or are inappropriate candidates for topical therapy and phototherapy.
Hidradenitis suppurative in adults and adolescents (from 12 years of age)
Idacio is indicated for the treatment of active moderate to severe hidradenitis suppuratives (acne inversa) in patients with an inadequate response to conventional systemic hidradenitis suppurativa therapy.
Idacio is indicated for the treatment of non-infectious intermediate, posterior and pan-uveitis in adult patients who have had an inadequate response to corticosteroids in patients in need of corticosteroid sparing, or in whom corticosteroid treatment is inappropriate.
Idacio is a biosimilar medicine to Humira (adalimumab).
Adalimumab binds to tumour necrosis factor (TNF) and neutralises the biological function of TNF by blocking its interaction with the p55 and p75 cell surface TNF receptors. TNF is a naturally occurring cytokine that is involved in normal inflammatory and immune responses. Elevated levels of TNF are found in the synovial fluid of rheumatoid arthritis (RA), including juvenile idiopathic arthritis (JIA), psoriatic arthritis (PsA) and ankylosing spondylitis (AS) patients and play an important role in both the pathologic inflammation and the joint destruction that are hallmarks of these diseases. Increased levels of TNF are also found in psoriasis (Ps) plaques, which contribute to the inflammatory response, to the proliferation and decreased maturation of keratinocytes and to the associated vascular damages that are characteristic of the disease.
Adalimumab also modulates biological responses that are induced or regulated by TNF, including changes in the levels of adhesion molecules responsible for leukocyte migration (endothelial cell leukocyte adhesion molecule-1 (ELAM-1),vascular cell adhesion molecule-1 (VCAM-1),and intercellular adhesion molecule-1 (ICAM-1) with a half maximal inhibitory concentration (IC50)of 1 - 2 x 10-10 M).
The following table summarises the key steps and dates for this application.
|Submission dossier accepted and first round evaluation commenced||2 September 2019|
|First round evaluation completed||21 February 2020|
|Sponsor provides responses on questions raised in first round evaluation||4 March 2020|
|Second round evaluation completed||17 April 2020|
|Delegate's overall benefit-risk assessment||9 June 2020|
|Sponsor's pre-Advisory Committee response||Not applicable|
|Advisory Committee meeting||Not applicable|
|Registration decision (Outcome)||15 June 2020|
|Completion of administrative activities and registration on ARTG||17 June 2020|
|Number of working days from submission dossier acceptance to registration decision*||183|
*Statutory timeframe for standard applications is 255 working days
- The Idacio European Union-Risk Management Plan (EU-RMP) (version 4.0, dated 26 April 2019, data lock point 28 February 2019), with Australian specific Annex (version 1.0, dated 26 February 2020), included with submission PM-2019-03192-1-1, to be revised to the satisfaction of the TGA, will be implemented in Australia.
An obligatory component of risk management plans is routine pharmacovigilance. Routine pharmacovigilance includes the submission of periodic safety update reports (PSURs).
Reports are to be provided in line with the current published list of EU reference dates and frequency of submission of PSURs until the period covered by such reports is not less than three years from the date of the approval letter.
The reports are to at least meet the requirements for PSURs as described in the European Medicines Agency's Guideline on Good Pharmacovigilance Practices (GVP) Module VII-periodic safety update report (Rev 1), Part VII.B Structures and processes. Note that submission of a PSUR does not constitute an application to vary the registration.
- It is a condition of registration that all batches of Idacio imported into/manufactured in Australia must comply with the product details and specifications approved during evaluation and detailed in the Certified Product Details (CPD).
It is a condition of registration that up to 5 initial batches of Idacio imported into/manufactured in Australia is not released for sale until samples and/or the manufacturer's release data have been assessed and endorsed for release by the TGA Laboratories Branch. Outcomes of laboratory testing are published biannually in the TGA Database of Laboratory Testing Results.
The sponsor should be prepared to provide product samples, reference materials and documentary evidence as defined by the TGA Laboratories branch. The sponsor must contact Biochemistry.Testing@health.gov.au for specific material requirements related to the batch release testing/assessment of the product. More information is available at TGA testing of biological medicines.
This batch release condition will be reviewed and may be modified on the basis of actual batch quality and consistency. This condition remains in place until the sponsor is notified in writing of any variation.
- Certified Product Details
The Certified Product Details (CPD), as described in Guidance 7: Certified Product Details of the Australian Regulatory Guidelines for Prescription Medicines (ARGPM), in PDF format, for the above products should be provided upon registration of these therapeutic goods. In addition, an updated CPD should be provided when changes to finished product specifications and test methods are approved in a Category 3 application or notified through a self-assessable change.
- For all injectable products the Product Information must be included with the product as a package insert.