Hulio
Registration timeline
The following table summarises the key steps and dates for this application.
| Description | Date |
|---|---|
| Submission dossier accepted and first round evaluation commenced | 2 June 2020 |
| First round evaluation completed | 2 November 2020 |
| Sponsor provides responses on questions raised in first round evaluation | 12 January 2021 |
| Second round evaluation completed | 16 February 2021 |
| Delegate's overall benefit-risk assessment | 15 March 2021 |
| Sponsor's pre-Advisory Committee response | Not applicable |
| Advisory Committee meeting | Not applicable |
| Registration decision (Outcome) | 7 April 2021 |
| Completion of administrative activities and registration on ARTG | 14 May 2021 |
| Number of working days from submission dossier acceptance to registration decision* | 172 |
*Statutory timeframe for standard applications is 255 working days
Dosage of Hulio is based on multiple factors, including the condition being treated, the age and the body weight of the patient.
For further information refer to the Product Information.
Hulio (adalimumab) was approved for the following therapeutic use:
Rheumatoid arthritis
Hulio 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.
Hulio can be used alone or in combination with methotrexate.
Juvenile idiopathic arthritisPolyarticular juvenile idiopathic arthritis
Hulio 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 antirheumatic drugs (DMARDs). HULIO can be given as monotherapy in case of intolerance to methotrexate or when continued treatment with methotrexate is inappropriate.
Enthesitis-related arthritis
Hulio 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.
Psoriatic arthritisHulio 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.
Ankylosing spondylitis
Hulio is indicated for reducing signs and symptoms in patients with active ankylosing spondylitis.
Crohn's disease in adults and children (≥ 6 years)
Hulio is indicated for the treatment of moderate to severe Crohn's disease, to reduce the signs and 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.
Ulcerative colitis
Hulio 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
Hulio is indicated for the treatment of moderate to severe chronic plaque psoriasis in adult patients who are candidates for systemic therapy or phototherapy.
Hulio 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 Suppurativa in Adults and Adolescents (from 12 years of age)
Hulio is indicated for the treatment of active moderate to severe hidradenitis suppurativa (acne inversa) in patients with an inadequate response to conventional systemic hidradenitis suppurativa therapy.
Uveitis
Hulio 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.
- The Hulio European Union (EU)-risk management plan (RMP) (version 3.2, dated 6 August 2020, data lock point 24 December 2019), with Australian-specific Annex (version 3.0, dated 22 February 2021), included with submission PM 2020 01807 1 3, and any subsequent revisions, as agreed with 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.
- All batches of Hulio supplied in Australia must comply with the product details and specifications approved during evaluation and detailed in the Certified Product Details (CPD).
When requested by the TGA, the sponsor should be prepared to provide product samples, specified reference materials and documentary evidence to enable the TGA to conduct laboratory testing on the Product. Outcomes of laboratory testing are published biannually in the TGA Database of Laboratory Testing Results, and periodically in testing reports on the TGA website.
Certified Product Details
The 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.
The CPD should be emailed to biochemistry.testing@health.gov.au as a single PDF document.
- For all Hulio products, either:
- a 'pack insert' (being an abbreviated version of the TGA-approved Hulio Product Information (PI)) in a format acceptable to the TGA, or
- the approved Product Information, must be included with the products as a package insert.
Where a 'pack insert' is provided as a package insert, there is a continuing obligation on the sponsor to ensure that the content is consistent with the PI.