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Abrilada
Sponsor
ARTGs
334496, 334497, 334498 and 334499
334496, 334497, 334498 and 334499
334496, 334497, 334498 and 334499
334496, 334497, 334498 and 334499
Device/Product name
Abrilada
Active Ingredient
Adalimumab
Date of decision
Published
Submission type
New biosimilar medicine
ATC codes
L04AB04
Decision
Approved
What was the decision based on
The decision was based on quality (chemistry and manufacturing), nonclinical (pharmacology and toxicology), clinical (pharmacology, safety and efficacy) and risk management plan information submitted by the sponsor. The benefit-risk profile of Abrilada was considered favourable for the therapeutic use approved.
What steps were involved in the decision process
Registration timeline
The following table summarises the key steps and dates for this comparable overseas regulator approach B (COR-B) application.
| Description | Date |
|---|---|
| Submission dossier accepted and first round evaluation commenced | 2 June 2020 |
| First round evaluation completed | 30 September 2020 |
| Sponsor provides responses on questions raised in first round evaluation | 2 November 2020 |
| Second round evaluation completed | 8 February 2021 |
| Delegate's overall benefit-risk assessment | 5 January 2021 |
| Sponsor's pre-Advisory Committee response | Not applicable |
| Advisory Committee meeting | Not applicable |
| Registration decision (Outcome) | 8 February 2021 |
| Completion of administrative activities and registration on ARTG | 22 February 2021 |
| Number of working days from submission dossier acceptance to registration decision* | 148 |
*The COR-B process has a 175 working day evaluation and decision timeframe.
Date of entry onto ARTG
Original publication date
Black triangle scheme
No
Dose forms
Solution for injection
Strength
20 mg and 40 mg
Other ingredients
Histidine, histidine hydrochloride monohydrate, disodium edetate, sucrose, methionine, polysorbate 80 and water for injections
Containers
Pre-filled syringe, pre-filled pen and vial
Pack sizes
2 pre-filled syringes (0.4 mL sterile solution)1, 2, 4 and 6 pre-filled syringe (0.8 mL sterile solution)1, 2, 4 and 6 pre-filled pen (0.8 mL sterile solution)1 pack of 2 boxes each containing 1 vial (0.8 mL sterile solution), 1 empty sterile injection syringe, 1 needle and 1 adapter.
Routes of administration
Subcutaneous injection
Dosage
The recommended dose of Abrilada for adult patients with rheumatoid arthritis is 40 mg administered fortnightly as a single dose. Methotrexate, glucocorticoids, salicylates, nonsteroidal anti-inflammatory drugs or analgesics may be continued during treatment with Abrilada.
Some patients not taking concomitant methotrexate may derive additional benefit from increasing the dosage of Abrilada to 40 mg every week, or 80 mg fortnightly.
Dosage of Abrilada 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.
Pregnancy category
CDrugs 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.
What was approved
Abrilada (adalimumab) was approved for the following therapeutic use:
Rheumatoid arthritis
Abrilada 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.
Abrilada can be used alone or in combination with methotrexate.
Juvenile idiopathic arthritis
Polyarticular juvenile idiopathic arthritis
Abrilada 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). Abrilada can be given as monotherapy in case of intolerance to methotrexate or when continued treatment with methotrexate is inappropriate.
Enthesitis-related arthritis
Abrilada 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 arthritis
Abrilada 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
Abrilada is indicated for reducing signs and symptoms in patients with active ankylosing spondylitis.
Abrilada 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;
Crohn's disease in adults and children (≥ 6 years)
- who have had an inadequate response to conventional therapies or,
- who have lost response to or are intolerant to infliximab.
Ulcerative colitis
Abrilada 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
Abrilada is indicated for the treatment of moderate to severe chronic plaque psoriasis in adult patients who are candidates for systemic therapy or phototherapy.
Abrilada 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)
Abrilada 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
Abrilada is indicated for the treatment of non-infectious intermediate, posterior and panuveitis 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.
What is this medicine and how does it work
Abrilada (adalimumab) is a biosimilar medicine to Humira.Adalimumab binds to tumor 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 leucocyte adhesion molecule (ELAM) -1, vascular cell adhesion molecules (VCAM)-1, and intercellular adhesion molecule (ICAM)-1 with an IC50 of 1-2 x 10-10 M).
What post-market commitments will the sponsor undertake
- The Abrilada European Union (EU) - Risk Management Plan (RMP) (version 1.0, dated 11 October 2019, data lock point 05 January 2018), with Australian specific annex (version 2.0, dated 12 October 2020), included with submission PM-2020-01818-1-3, 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 this 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.
- Laboratory testing & compliance with Certified Product Details (CPD)
All batches of Abrilada supplied in Australia must comply with the product details and specifications approved during evaluation and detailed in the 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.
- For all injectable products the Product Information must be included with the product as a package insert.