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Thursday, February 9, 2017

US draft guidelines on interchangeability of biosimilars require repeat switches – why doesn't Australia switch over too?

By Sarah Matheson and Ric Morgan

As we have previously reported, it has long looked like Australia is determined to take a unique stance on interchangeability of biosimilars. This was confirmed with the PBAC recommending the a-flagging of Brenzys in September 2016.  The recent release for comment by the US FDA of its much awaited draft industry guidance on demonstrating interchangeability of biosimilars reinforces that Australia is indeed an island when it comes to biosimilars.

If adopted, as seems likely, the separate assessment of interchangeability under US legislation will require specific clinical trials. For biosimilars intended to be administered more than once, dedicated switching studies will need to: