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Australia’s Therapeutic Goods Administration (TGA) has updated it regulations regarding the registration of biosimilar medicines. The agency has adopted a number of European guidelines that outline the quality, nonclinical, and clinical data requirements specific to biosimilar medicines, along with the ICH guideline on the assessment of comparability (Q5E). In addition, the update includes details around the reference product – which much be sourced in Australia – and data requirements for the CTD application. CTD Module 3 of the submission will require “significant modification” from the EU dossier, as it will need to include: ● information on the in-house standard ● bridging comparability studies ● shipping stability, and ● labelling.
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INTERNATIONAL PHARMACEUTICAL QUALITY
Inside the Global Regulatory Dialogue
