On 18 June 2015, Australia’s reimbursement agency the Pharmaceutical Benefits Advisory Committee (PBAC) released a statement entitled ‘Safety of biosimilar medicines’. In this statement, the PBAC recommended allowing the substitution of biosimilar drugs by clinicians and pharmacists – if the biosimilar is proven to have the same safety and efficacy as the innovator drug. The PBAC has not given a blanket approval for substitution of biosimilar; the PBAC will consider on a case-by-case basis whether the drug can be substituted by the doctor or pharmacist.

The PBAC consider that if the Therapeutic Goods Administration (TGA) have determined the biosimiar has similar safety and efficacy to that of the innovator, then the PBAC will consider listing the drug on the PBAC.

If the PBAC decides that a biosimilar should be substitutable, the doctor or pharmacist can offer a choice for the patient, however, the patient has the ultimate choice. The physician can also indicate on the script that substitution is not allowed – as is the current practice for generic drugs.

Currently the EMA guidelines do not address the issue of interchangeability however it is clearly defined in the US law (BPCIA). The implementation of  interchangeability of biosimilars in the US, has however, not been outlined in specific guidelines.

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