Merck Sharp & Dohme’s Ontruzant has become the fourth trastuzumab biosimilar to be reimbursed in Australia, while Pfizer’s Trazimera is in line to be the fifth.

A body that advises Australia’s Department of Health on reimbursement will in November consider listing applications for Sandoz’ Ziextenzo pegfilgrastim candidate and well as for Pfizer’s recently authorized Trazimera trastuzumab brand.

Commissioner says agency will modernize drug patent reference manual this year and consider potential changes to Orange Book administration policy. However, any transformative moves could trigger a court challenge.

Australia’s pharmaceutical industry says it faces hard times, despite a recent report highlighting sales and exports. But challenges are expanding for many companies that face patent expirations, paving the way for generic manufacturers to drive prices down.