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Juno Pharmaceuticals and Amgen Australia announce partnership for the marketing and distribution of biologic medicines Neulasta® (Pegfilgrastim) and Ristempa® (Pegfilgrastim) in Australia.

MELBOURNE, AUSTRALIA – Juno Pharmaceuticals is pleased to announce that Amgen Australia have appointed us as their distribution partner for the exclusive marketing and distribution of Amgen’s biologic medicines Neulasta (Pegfilgrastim) and the launch of Ristempa (Pegfilgrastim). Read more

Canadian Biosimilar Approval Process Update

The Canadian Agency for Drugs and Technology in Health (CADTH) are revising the regulatory process for biosimilars. Following a period of consultation, CADTH has streamlined the assessment process for biosimilars, with shorter approval timelines, fewer submission requirements and abbreviated biosimilar dossier templates. Read more

Introduction of Biosimilar Uptake Drivers in Australia

New biosimilar uptake drivers negotiated late last year, including ‘streamlined authority’ prescribing appear to be making a positive impact on uptake. Read more

Biosimilar Nomenclature in Australia

In 2017, the TGA opened a public consultation regarding the naming of biosimilars. The objective of this consultation was to determine whether biological medicines in Australia required additional naming requirements, in order to strengthen traceability and pharmacovigilance1. Read more