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Abrilada

4 March 2021

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

Summary of submission

Submission type
New biosimilar medicine
Product name

Abrilada

Active ingredients
Adalimumab
ATC codes
L04AB04
Decision
Approved
Date of decision
8 February 2021
Date of entry onto ARTG
22 February 2021
Original publication date
4 February 2021
ARTG numbers
334496, 334497, 334498 and 334499
Black Triangle Scheme
No
Sponsor
Pfizer Australia Pty Ltd
Sponsor address
Level 17, 151 Clarence Street, Sydney NSW 2000
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

C

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.

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?

What was the decision based on?

What steps were involved in the decision process?

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.

Further information

The latest Product Information (PI) and Consumer Medicines Information (CMI) can be found at: ARTG search.

Australian Public Assessment Reports (AusPARs) can be found at: AusPAR search.

The latest news and updates regarding therapeutic goods regulation can be found at: TGA news room.