Posted by Michael Wonder on 22 Feb 2018
Biosimilar medicines regulation
22 February 2018 - This guidance assists sponsors of biosimilar medicines to complete an application to register their medicine on the Australian Register of Therapeutic Goods and to understand their ongoing sponsor responsibilities.
Applications for biosimilar medicines registration must meet the same requirements as for prescription medicines. Read this guidance in conjunction with our guidance on the prescription medicines registration process.
The TGA has adopted a number of European guidelines that outline the quality, nonclinical and clinical data requirements specific to biosimilar medicines; and the ICH guideline on the assessment of comparability.
