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Australia: TGA Released Guidance on Biosimilar Medicines

Thursday, February 22, 2018: The Therapeutic Goods Administration (TGA) of Australia has released guidance on biosimilar medicines to assists sponsors of biosimilar medicines to complete an application to register their medicine on the Australian Register of Therapeutic Goods (ARTG) and to understand their ongoing sponsor responsibilities. Applications for biosimilar medicines registration must meet the same requirements as for prescription medicines.

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