A reformulated ‘less painful’ version of Humira will be listed on the PBS from April 1, along with four adalimumab biosimilars accepted into the Australian subsidy scheme.
AbbVie’s revised version of its best-selling anti-TNF drug has been available for some years in overseas markets and is documented as causing less pain and discomfort on injection than the original formula containing citrate.
The four biosimilars are: Amgevita, (Amgen); Hadlima (Samsung Bioepsis); Hyrimoz (Sandoz) and Idacio (Fresnius Kabi). Among them, only Amgevita does not employ citrate as a stabilising buffer ingredient, according to TGA documents.
Humira and the four biosimilars are indicated for a range of autoimmune conditions including chronic plaque psoriasis, psoriatic arthritis, hidradenitis suppurativa and rheumatoid arthritis, and Crohn’s Disease. The biosimilars are ‘a-flagged’, meaning that pharmacists are allowed to substitute between originator and biosimilar brands according to their authority level, form and strength, in consultation with the patient.
Dr Davinder Singh-Grewal, chair of the Australian Paediatric Rheumatology Group, said steps to reduce the discomfort of fortnightly injections administered to adalimumab patients would be a game changer young patients. In children, the drug was PBS-indicated only for juvenile arthritis that is resistant to treatment with methotrexate.
“The only drawback for the drug is the delivery by injection,” he said.
“Not only is the piercing of the skin painful, but the actual substance being injected has been quite painful and stinging.”
“Many patients feel the benefit of the medication is so great that they are willing to tolerate the injection – that’s certainly the case in adults. But a lot of kids don’t understand the reason for the injection and so on, and it’s a big struggle for them and their families to administer these injections.”
With citrate-free Humira available overseas for some years, there was clear evidence that it can lift quality of life for children and their families, said Queensland-based gastroenterologist Dr Jakob Begun.
“For some patients the anxiety and pain is a major issue,” he said, adding that he had known patients to delay their injections, affecting their clinical care, and one had to switch to an infusional therapy because of the psychological toll.
With the new formulation, AbbVie has also introduced a new autoinjector pen, a smaller 29-gauge needle and a reduced injection volume – all of which it says will help reduce pain and discomfort for patients.
Dr Begun, the chair of GESA’s IBD faculty, said he expected the redesigned device would make it easier for his large patient cohort of adolescents and young adults to self-administer.
“And from the clinician’s standpoint, it makes it easier to make decisions if we know a drug is well tolerated by patients and with the new formulation its efficacy hasn’t changed at all.”
The government’s biosimilar prescribign incentives are based on the belief that the added competition from biosimilars to originator brands will bring savings to the PBS. Humira has been one of the more costly drugs for the PBS with a cost to government of almost $320 million in 2019-20, at an average price of $1,275.50 per script.
Disclosure: Dr Begun declared the following interests: honoraria, research grants or consulting fees from Abbvie, Janssen, Takeda, Pfizer, Ferring, Bristol Myers Squibb, Gilead,
Tillott’s, Sandoz, Chiesi, Celltrion, Microba, Antara. Dr Davinder Singh-Grewal decalred no interest.