Filgrastim products ruled bioequivalent

The PBAC has recommended that filgrastim (Neupogen) and its three biosimilars (Nivestim, Tevagrastim and Zarzio) can be marked as equivalent for the purposes of substitution.

The decision, made at the PBAC’s April meeting and reported last week, applies to all indications including treatment of chemotherapy-induced and other neutropenias or for mobilisation of peripheral blood progenitor cells ahead of bone marrow or cell transplantation.

The PBAC ‘Positive Recommendations’ document said the decision was based on currently available evidence for similar efficacy and safety of the biosimilars with the reference biologic.

“In making this recommendation, the PBAC noted there is limited high quality evidence specifically analysing the impact of treatment switching between different filgrastim brands, and further noted most of the evidence available were single arm and/or open-label studies, which often used historical cohorts for the reference biologic.”

It also noted a 2012 review that found no evidence of major safety concerns associated with switching between different filgrastim products.

The PBAC said there was no data that pointed to major safety concerns associated with switching between different granulocyte colony stimulating factors (G-CSF).

And the TGA had previously determined the currently PBS-listed filgrastim biosimilars had demonstrated therapeutic equivalence to the reference brand.

The PBAC also recommended that the Section 100 (Highly Specialised Drugs Program – Private Hospital) listings of filgrastim should be lowered to a streamlined authority

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