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June 22, 2015.
Australia’s Pharmaceutical Benefits Advisory Committee (PBAC) has recommended that biosimilars are suitable for substitution at the pharmacy level. The Generics and Biosimilars Initiative (GaBi) website reports that medicines deemed substitutable at the pharmacy level by the PBAC include a notation in the official Pharmaceutical Benefits Schedule known as an ‘a’ flag. The PBAC advised that absence of data to suggest significant differences in clinical effectiveness or safety compared with the originator and availability of data for treatment-naïve patients initiating on the biosimilar would be among the relevant considerations in establishing that a biosimilar could be ‘a’ flagged with the originator biological. Washington DC's Alliance for Safe Biologic Medicines (ASBM) condemned the PBAC recommendations, which position Australia as the first and only nation to allow pharmacy-level substitution of biologic medicines without physician involvement. PR Newswire reports that ASBM Advisory Board member Stephen Murby said: "Allowing automatic substitution of biosimilars is an enormously retrograde step for Australia. One which is completely out-of-kilter with world best practice and which has the potential to reduce the standards of safe use of biosimilars for patients."