Pharmacy Daily | Pharmacy biosimilar alert

Medicines Australia (MA) has expressed concern over the Pharmaceutical Benefits Advisory Committee decision to allow pharmacists to substitute biosimilar drugs in place of biologics prescribed by a patient’s doctor. So-called “a-flagging” of infliximab (Inflectra) was announced last week and championed by the Generic and Biosimilar Medicines Association (PD Fri), allowing pharmacists to substitute the biosimilar for Remicade “without the consent of either the prescribing doctor or the patient,” MA said. While representing the makers of original biologic medicines, MA members also include the majority of biosimilar medicines manufacturers and consequently MA said it supports the introduction and uptake of biosimilars. Nevertheless allowing pharmacists to substitute the medicines “goes against all the advice...received from international and local experts that there is an absence of an agreed evidence base to support the safety and efficacy of repeated, or multiple, switching between a biologic and one or more biosimilar medicines,” MA warned. The organisation called on the government to begin a formal process of consultation to develop a comprehensive biosimilars policy, based on evidence, and including appropriate education, which “puts patient safety first,” MA said. “The medical and patient community need confidence that the Australian government and its appointed advisory bodies are making the right decisions in the interest of their health and safety and not based on the government’s own bottom line savings targets.” However new fact sheets published on the PBS website confirm that doctors retain prescribing control by ticking the ‘no substitution’ box on scripts, while patients are also able to choose a biosimilar at the pharmacy - see pbs.gov.au.

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