Ensure the same reference product is used for both drug substance and drug product and in all three (Quality, Safety and Efficacy - Modules 3-5) parts of the submission.

Ensure the reference product is clearly identified by:

• brand name
• pharmaceutical form
• formulation
• strength
• origin or place of purchase
• batch numbers and dates of expiry.

Ensure the biosimilar has the same formulation, strength and dosage form as the reference product, or include a scientific justification for any differences.

Use state-of-the-art analytical methods to directly compare the reference product to the biosimilar.

Notes about the reference product

Ensure the reference product:

• is not an international standard
• is registered in Australia
• is not itself an biosimilar, but is a biological medicine registered by means of a full data submission in all Modules
• has been marketed for a suitable duration and have a volume of marketed use so that there is likely to be a substantial body of acceptable data regarding the safety and efficacy.

For reference products that are registered in Australia but manufactured overseas

A reference product manufactured and sourced overseas may be used, provided:

• the product is registered in Australia
• a bridging comparability study between the Australian-sourced product and all batches of the reference product is provided.