Adalimumab biosimilar wins support for PBS listing


By Geir O'Rourke

16 Jan 2024

The Pharmaceutical Benefits Advisory Committee (PBAC) has signalled its support for a biosimilar of the anti-TNF adalimumab to be listed on the PBS, with severe chronic plaque psoriasis and hidradenitis suppurativa among the recommended indications.

Following its latest meeting, the committee has also come out in favour of allowing rheumatologists to prescribe apremilast for chronic plaque psoriasis (see below for details).

Branded Hadlima, the adalimumab product would be available in the forms of 40 mg in 0.4 mL pre-filled pen (PFP) and pre-filled syringe (PFS) as biosimilar brands of Humira.

Dermatological indications included severe chronic plaque psoriasis and moderate to severe hidradenitis suppurativa, with a number of applications in gastroenterology and rheumatology also supported.

he PBAC’s recommendation for listing was based on, among other matters, its assessment that the cost-effectiveness of Hadlima PFP and PFS would be acceptable if it were cost-minimised to the lowest cost PBS-listed adalimumab brand.

Equi-effective doses would be 1 mg of Hadlima = 1 mg of Humira and all other biosimilar brands and formulations of adalimumab, it said in an outcomes statement following its November 2023 meeting (link here).

As with the listing of the originator biologic, Hadlima will require written authority, with all other restrictions being identical, per the outcomes statement.

Regarding substitution, the PBAC recommended:

  • Hadlima and Humira PFS should be treated as equivalent to each other;
  • Hadlima and Humira PFP should be treated as equivalent to each other (i.e. ‘a’ flagged in the Schedule).
  • Adalimumab 40 mg in 0.4 mL and adalimumab 40 mg in 0.8 mL PFS should be treated as equivalent to each other for the purposes of substitution;
  • Adalimumab 40 mg in 0.4 mL and adalimumab 40 mg in 0.8 mL PFP should be treated as equivalent to each other for the purposes of substitution.
  • Hadlima PFP should not be considered equivalent for the purposes of substitution with any adalimumab PFS, consistent with its previous considerations of adalimumab.

More approved prescribers of apremilast

Meanwhile, the PBAC recommended the following changes to the treatment criteria of apremilast (Otezla) for the treatment of severe CPP in patients who have failed treatment with, or who are contraindicated or intolerant, to methotrexate:

  • To allow rheumatologists and general physicians to initiate treatment (in addition to dermatologists).
  • To allow rheumatology registrars to initiate treatment in consultation with one of the above practitioner types (in addition to dermatology registrars).

However it declined to back a further change requested by Otezla importer Amgen to allow GPs to initiate treatment with the drug.

This reflected the fact that the proposed treatment criteria was broad and that the required experience was “not ascertainable in a manner that can be verified”, the PBAC said.

As a result, there was a risk of misdiagnosis and improper prescribing, according to the committee, which did not GPs were currently able to prescribe continuing treatment in agreement with a designated specialist.

Beyond that, it said the Prescribing Instruction regarding the need for prescribers to complete a Psoriasis Area and Severity Index assessment for patients to move onto biologic treatments should be included in the restriction for apremilast and should flow onto ciclosporin and deucravacitinib.

And it recommended that the changes to the initial treatment criteria for apremilast should flow onto ciclosporin for the treatment of CPP, and that all of the recommended changes to the treatment criteria for apremilast should flow onto the listings for deucravacitinib for severe CPP.


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