The Alliance for Safe Biologic Medicines (ASBM) today condemned recent announcements by Australian Health Minister Sussan Ley and the Pharmaceutical Benefits Advisory Committee (PBAC) that Australia would break with widely-held international standards by becoming the first and only nation to allow pharmacy-level substitution of biologic medicines without physician involvement.
Patient advocate Stephen Murby, former chair of the Consumers Health Forum and an ASBM Advisory Board member said of the move: "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."
Biosimilars are copies of the biologic medicines used to treat serious conditions such as rheumatoid arthritis, multiple sclerosis and cancer- potentially at lower costs. Yet unlike generic versions of chemical drugs, which are structurally identical to their reference products, biosimilars are merely "similar" to their reference products. Even seemingly minor differences between two similar biologics can produce unexpected effects in patients, such as unwanted immune responses that harm rather than heal.