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Evaluation of biosimilars
Labels, product information (PI) and consumer medicine information (CMI) for biosimilars
As for all NCE and NBE applications, biosimilar applications are required to comply with:
- TGO No. 69 - General requirements for labels for medicines for labelling
- the Product Information guideline and Schedule 13 of the Regulations for the PI.
The CMI must:
- be consistent with the PI
- contain the information required by Schedule 12 of the Regulations.
Relevant clinical trial information generated on the reference product and reported in the reference product PI may be incorporated into the PI for the biosimilar. However these data should be clearly identified as having been produced using the reference product not the biosimilar.
As biosimilars are not generic versions of their reference products, to inform the prescriber the text of the PI should include words to the effect of:
"The comparability of [biosimilar product name] with [Reference product name (AustR nnnnnn)] has been demonstrated, with regard to particular physicochemical characteristics and efficacy and safety outcomes [see PHARMACOLOGY and CLINICAL TRIALS]. The level of comparability that has been shown supports the use of [biosimilar product name] for the listed indication[s]. The level of comparability that has been shown is not sufficient to designate this product as a generic version of [Reference product name]. Replacement of [Reference product name] with [biosimilar product name], or vice versa, should take place only under the supervision of the prescribing medical practitioner."
as the first paragraph under Precautions.
In addition the approval letter is likely to include text similar to the following:
"The application for registration of [biosimilar product name] included data that established to the TGA's satisfaction that the product is a biosimilar to [Reference product name (AustR nnnnnn)].
A biosimilar is a version of an already registered biological medicinal product with demonstrated similarity in physicochemical, biological and immunological characteristics, efficacy and safety, based on a comprehensive comparability analysis.
It is the TGA's view that it is not currently possible to determine a degree of similarity, between a biosimilar and an already registered biological medicine sufficient to support a designation by the TGA of 'bioequivalence'."