AusBiotech has written to Health Minister Sussan Ley expressing concern over proposed pharmacy-level substitution of biosimilars.
CEO, Dr Anna Lavelle, wrote to Ms Ley last week in response to publication of the outcomes of the special out-of-session meeting of the Pharmaceutical Benefits Advisory Committee (PBAC).
According to the outcomes statement, the PBAC determined that 'a' flagging of biosimilars, allowing pharmacy-level switching for the reference biologic, would be its default position.
While the Department of Health has subsequently emphasised the importance of data to support switching, in its outcomes statement the PBAC appeared to imply that, in the absence of data demonstrating that a biosimilar was 'interchangeable' with its reference biologic, it would invoke its base-case assumption and allow switching.
The statement has generated significant confusion and angst in Australia and overseas, across industry and patient groups.
"Read alone this appears to carry risk and to be a poor fit with evidence-based decision making. It would also put Australia out of step with global best practice," said Dr Lavelle.
"...the treatment of biosimilars 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. Substitution increases the potential for adverse immune reactions in patients, the extent of which is not fully understood. Allowing pharmacy substitution is therefore questionable in the absence of reference to the prescribing clinician."
Dr Lavelle goes on to say that the public safety and efficacy of treatment and changes to treatment are best managed at this stage of known evidence by clinicians and that the TGA should continue to be the ultimate arbiter on safety and efficacy.
The US-based Biotechnology Industry Organisation has also intervened.
In a letter to Ms Ley, CEO James Greenwood said that the issue of pharmacy-level substitution, "and the risks associated with it, has been debated extensively in – and consistently rejected by – countries with robust regulatory framework and an ability to evaluate the scientific properties of these important medicines."
He continued, "Many countries to date have uniformly clearly determined generics-styled substitution of similar biological medicines as inappropriate. In short, the policies being considered by Australia run contrary to sound scientific policy and medical practice and are thus inconsistent with the global best practice of other advanced economies."
He cited the UK, Germany, Ireland, Spain, Sweden, Norway, and Finland, "among others", as countries that have "outlawed pharmacy-level substitution" of biosimilars.
"Many others, including Italy, Belgium, Switzerland, and Denmark have issued formal guidance that pharmacy-level substitution is not appropriate for similar biological medicines," he said.
In a recent statement, the Deparment of Health said, "France and the United States have recently introduced measures to permit pharmacists to substitute a biosimilar in place of the branded product."
However, according to Mr Greenwood, France limits pharmacy-level substitution to "the point of treatment initiation and with the consent and guidance of the physician. Once a patient begins a biotherapy regimen, the pharmacist is obliged to dispense only the medicine upon which the patient has commenced."
As for the US, he says that the current law "explicitly requires that the risks to patients of repeated switching, which may occur through pharmacy-level substitution, be evaluated specifically by the Food and Drug Administration.
"The law requires that applicants for approval of a biosimilar medicine submit evidence to demonstrate that such switching will not place any patient at greater risk than if switching did not occur. This is a higher standard of evidence than that required for establishing simple biosimilarity; demonstrating biosimilarity is not sufficient in itself to warrant interchangeability, which would permit pharmacy-level substitution in the US."
He goes on to say that BIO is "not questioning the overall safety or efficacy of biosimilars," simply that the "effects of repeatedly alternating among two or more similar biological medicines have not - to the best of our knowledge - been fully evaluated by the Australian regulator."
"Biosimilars have the potential to generate important efficiencies for healthcare systems facing fiscal pressures, but ensuring that this occurs without putting patients at risk is paramount. Many countries in Europe have seen significant savings to pharmaceutical budgets due to biosimilar competition, even without pharmacy-level substitution of these medicines," said Mr Greenwood.
In a separate letter to Ms Ley, the Alliance for Safe Biologic Medicines, says it opposes pharmacy-level substitution of biosimilars until they "have been sufficiently evaluated for safety and efficacy, including repeated switching between products -- whether it be between the reference biologic and a biosimilar or between two biosimilars."
The Alliance describes itself as an organisation of "physicians, pharmacists, patients and manufacturers of both biologics and biosimilar working together to promote their safe use".
Accordng to its Chairman, Pediatric Rheumatologist Harry Gewanter, "We fully understand that this is a difficult scientific and regulatory question and warrants thoughtful handling on the part of all governments. We also fully understand the potential fiscal impacts of these medications to healthcare payers and realize that these costs cannot be ignored."
However, he says, "...given the chronicity and seriousness of the diseases these medications are designed to treat, we believe there is less margin for error and recommend a slower and more conservative approach to substitution until more is known about these medications."