The Alliance for Safe Biologic Medicines (ASBM), which represents originator companies, such as Amgen, and the Biotechnology Industry Organization in the US, has condemned recent announcements by the PBAC and Australian Health Minister Sussan Ley. The ASBM says that ‘Australia would break with widely-held international standards by becoming the first and only nation to allow pharmacy-level substitution of biologic[al] medicines without physician involvement’.

Meanwhile, Medicines Australia told a Senate committee on 18 June 2015 that it opposes the move by the PBAC. In fact, Medicines Australia CEO Tim James has stated that while ‘Medicines Australia does support clinician-led substitution of biosimilar medicines’; the association, which represents originator biologicals companies, ‘would support pharmacy-level substitution only based on a transparent decision-making process supported by appropriate evidence’.

The Australian Rheumatology Association (ARA) has also expressed concerns about risks to patient safety. Dr Mona Marabani, President of the ARA, said that ‘the proposed new powers will allow pharmacists to switch particular drugs at the pharmacy counter with the potential for patients to get a different drug every time they go to the chemist’. She added that ‘we have no problem with patients who are new to this type of therapy starting on a biosimilar where there is clinical trial evidence that such a drug is appropriate for the disease, but we do not support a system permitting multiple substitutions of drugs, because the consequences are unknown.’

Neither Health Canada nor the European Medicines Agency (EMA), both of which have approved biosimilars for clinical use, support automatic substitution. In the European Union, EMA does not make any decisions on substitution of biosimilars. This is made at a Member State level. And, as Dr Marabani points out, pharmacy-level substitution of biosimilars has been banned in many EU countries ‘including the UK, Germany, Ireland, Spain, Sweden, Norway, and Finland’.

France, has introduced legislation allowing substitution of biosimilars under certain conditions, including only when initiating a course of treatment. However, certain decrees still require passing into law before the practice can be implemented [2].

In the US, the Food and Drug Administration which recently approved its first biosimilar, has not yet defined what data would need to be provided in order for an approved biosimilar to be safely substituted without physician involvement.

Currently, 25% of the Pharmaceutical Benefits Scheme (PBS) is made up of biologicals, but with many biologicals now losing patent protection the Australian Government is looking to make savings on these costly treatments.

The PBAC has pointed out that any decision on allowing substitution by a physician or pharmacist will be made ‘on a case by case basis’. Patients will have the choice of taking the originator biological or the substitute biosimilar, just as they currently do with generics. In addition, the PBAC states that ‘clinicians would still have the ability to indicate a biological drug is not to be substituted for a biosimilar for their patient if they do not consider it appropriate in that particular case, i.e. this just requires them to tick brand substitution not permitted on the prescription.

The PBAC intends to hold a meeting with stakeholders to consult on how this initiative can be successfully applied in practice.

Related article
Finnish drug regulator recommends substitution of biosimilars

References
1. GaBI Online - Generics and Biosimilars Initiative. Australia’s PBAC recommends substitution of biosimilars [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2015 Jun 26]. Available from: www.gabionline.net/Biosimilars/General/Australia-s-PBAC-recommends-substitution-of-biosimilars
2. GaBI Online - Generics and Biosimilars Initiative. France to allow biosimilars substitution [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2015 Jun 26]. Available from: www.gabionline.net/Policies-Legislation/France-to-allow-biosimilars-substitution

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