As for all newly-registered biological medicines, biosimilars are placed on batch release as a condition of registration. This usually entails:

• the submission of release certification and shipping records for all batches
• the submission of samples for all batches having unique drug substances which may be tested by the TGA for compliance
• the continuance of these conditions until satisfactory batch consistency has been demonstrated (usually at least five batches of unique drug substance).

After the initial batch release phase is completed, the sponsor of the biosimilar is required to submit an annual report of all batches and to provide samples to the TGA for testing in periodic product surveys.

Variation of the conditions of registration can occur under section 9D using the normal Category 3 and self-assessable request processes. If there is a significant change in manufacturing process, a comparability study between the in-house reference standard as well as the pre- and post-change product will be required.