We need to hasten slowly on biosimilars, says Stephen Murby, who was speaking to BiotechDispatch late Wednesday after attending a consumer representative organisation forum on biosimilars.
Murby, who served as CHF Chair from 2010 to 2012, is currently biosimilars spokesperson for the International Alliance of Patients’ Organizations headquartered in London.
He has been in Australia since Monday, having observed the recent debate over biosimilars from his home in Scotland, and says one of the key problems he sees is the lack of agreement on the definition of key terms.
"We need to get consensus on the definition of key terms, such as switching, which occurs at the clinician level, and substitution, which is done at pharmacy level," he told BiotechDispatch. "We won't get progress until we get clarity and agreement on the terminology."
Since arriving, Murby has met with representatives of the TGA, Department of Health and Pharmaceutical Benefits Advisory Committee (PBAC).
He says one of the issues that has become very apparent during his time in Australia is the belief of some policy-makers that existing regulation and reimbursement processes can simply be applied to biosimilars.
"When we move from small molecules and biologics to biosimilars the world goes from being flat to round," says Murby. "We can't use existing frameworks because biosimilars are very different - we need a different way of doing things."
This is a point made by AusBiotech in correspondence to Health Minister Sussan Ley.
In the letter, CEO Dr Anna Lavelle said the proposed treatment of biosimilars, essentially as generics, is "neither a comfortable fit, nor a safe way forward for Australian patients at this time."
"It may well be a viable option in the future, once evidence is sought and assessed, but cannot be justified on our current global experience," she said.
Murby says the TGA seems to understand "what we're talking about" when it comes to needing a new approach, but the Department of Health and PBAC are just saying "trust us".
"Everyone aroound the world has their training wheels on because there is limited experience with biosimilars. In Australia, while just three biologics have lost patent protection, there are another 200 moving towards the end of their life cycle, and it seems the Department and PBAC are just making it up as they go," says Murby, going on to say that, done well, biosimilars have the potential to deliver significant savings to the health system.
He says there are two different conversations going on, describing the attitude of the Department and PBAC as "holier than thou."
Murby argues that the decision to use traditional terms such as 'a flagging' and 'pharmacy-level substitution' in its April statement only succeeded in demonstrating to the world that the PBAC did not understand the issues "or know what they were talking about."
"They are completely isolated on this, globally, because every other regulator is focussed on switching by clinicians, not substitution by pharmacists," he says. "They seem to be approaching this from the perspective of 'winners and losers', which simply isn't the way to go."
On the workshop, Murby says it was a very good opportunity for patient engagement, and that there was agreement on the need to be using the same terminology.
"There was a real sense that pharmacy, clinicians and patients can work on this in advance of the PBAC's stakeholder consultation meeting on 7 July," he says.