Etanercept biosimilar approval reignites ‘a-flagging’ concerns

The recent TGA approval of the etanercept biosimilar Brenzys™ has reignited concerns around the pharmacist substitution of originator biologics for biosimilars.

Marketed by MSD in Australia Brenzys™ is the first biosimilar of Pfizer’s originator drug Enbrel™ and follows hot on the heels of the infliximab biosimilar Inflectra™ which received  a PBS listing in December last year.

Peak Professional bodies and patient advocacy groups have largely welcomed the introduction of biosimilars to the Australian market, noting that their availability could help contain healthcare costs and allow increased access to biologic/biosimilar treatments in rheumatology.

However as previously reported by the limbic the unprecedented decision to allow Inflectra™ to be  ‘a’ flagged’ – whereby pharmacists are permitted to substitute biologics for biosimilars – has consistently been met with concern from several professional bodies and patient advocacy groups including the ARA and Arthritis Australia.

Speaking to the limbic the ARA President at the time Dr Mona Marabani said the decision to allow ‘a-flagging’ was the first step of a process that concerns rheumatologists.

“Should other large molecule biosimilars, particularly those delivered by the patients themselves via subcutaneous injection, be ‘a’ flagged in future, multiple substitutions at the retail pharmacy level could occur on a month-to-month basis,” she said.

Speaking to the limbic on the TGA approval of Brenzys™ Dr Marabani reiterated that the ‘a-flagging’ of an etanercept biosimilar would provide significant challenges to rheumatologists, pharmacists and patients.

She said there was very limited switching data for Enbrel™ and Brenzys™, although an abstract presented at EULAR indicated that a single switch from the originator to the biosimilar showed no loss of efficacy or toxicity signals.

However the numbers were small, the follow-up period was relatively short and the full study was yet to be published, she told the limbic.

“Added to this are the practical considerations of the dispensing of a subcutaneously administered drug by community pharmacies- different syringes and delivery devices with the potential to cause confusion for patients,” she said.

The Australian Rheumatology Association has previously advised its members to prescribe by brand name (either originator of biosimilar) and to ‘tick the box’ so that no substitution takes place.

“In general we would suggest staying with one drug as we do not know the effects of multiple substitutions,” said Dr Marabani who is chair of the ARA biosimilars working group.

The ARA has been working with the government to implement a new electronic prescribing system to replace the current paper system of prescribing biologics.

“The ARA was assured by the Department of Human Services that e-prescribing is a priority… Now that the business of government has resumed after the election, we hope for a speedy conclusion to this process,” she said.

“We continue to advocate to the Department of Human Services, PBAC, and Medicare for the ARA to undertake the necessary pharmacovigilance and surveillance needed for the safe introduction of biosimilars,” she added.

MSD medical director Dr Gary Jankelowitz said the TGA approval of Brenzys™represented “real progress in our efforts to offer Australian patients and healthcare professionals a pipeline of high-quality biosimilars in the future.”

He said the next focus was on a possible PBS listing given that Brenzys™was on the July PBAC agenda.

“Pending education of healthcare professionals and successful reimbursement, we would hope to make Brenzys™ available in Australia in early 2017,” he said.

If approved for reimbursement, Brenzys will become the first immunology biosimilar in Australia to be predominantly dispensed via community pharmacy.

“We recognise that education will be pivotal to help raise awareness among community pharmacists on the role and benefits of biosimilars. These educational programs will take some time to implement,” said Dr Jankelowitz.

BRENZYS is indicated for the following: rheumatoid arthritis (RA); psoriatic arthritis (PsA); plaque psoriasis; ankylosing spondylitis (AS); non-radiographic axial spondyloarthritis in adults ( 18 years); It is not indicated for use in children under 18 years. It is marketed as Benpali in some countries and has been developed by Samsung Bioepis.

Editors note: This article has been updated to correct an error in the approved indications for Brenzys. 

Related stories: 

Biosimilar reference group stalls

Infliximab biosimilar gets PBS listing

Biosimilar ‘a’ flagging still a concern 

Professional bodies join forces on ‘a’-flagging

Australian patients part of a “world-first” experiment

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