The Therapeutic Goods Administration (TGA) is the regulatory body for therapeutic goods (including medicines, medical devices, gene technology, and blood products) in Australia.
TGA has previously issued biosimilars guidelines, adopted them from the European Union but yesterday, they issued a new guidance for the evaluation of biosimilars.
The purpose of the guidance is to:
- Assist sponsors to identify the data necessary to support applications for the registration of biosimilars
- Clarify the scientific and regulatory principles used by the TGA to evaluate those applications.
This guidance refers solely to the evaluation of biosimilars and the contents are:
– What is a biosimilar? Describes biosimilars and explains why they are not are the same as generic medicines
– The legislative provisions for the evaluation of biosimilars: Identifies the sections of the Act that relate to the evaluation of applications to register biological medicines and the Therapeutic Goods Orders that also apply
– The evaluation of biosimilars: Includes guidance on:
- General process and data requirements
- What to include in an application to register a biosimilar
- Pre-submission meetings
- Evaluation of the CTD Modules
- Advisory committee advice about biosimilars.
– Reference products for biosimilars: Provides guidance for reference products that are registered but manufactured overseas.
– In-house primary reference standard for biosimilars
– Comparability studies for evaluating biosimilars: Includes guidance on:
- Physicochemical properties
- Biological activity
- Content, purity and impurity profile
- Glycosylation (if applicable)
- Immunochemistry (if applicable e.g. monoclonal antibodies).
– Extrapolation of indications: Information required by the adopted EU guideline to facilitate extrapolation of indications from reference product to biosimilar.
– Post registration regulation of biosimilars: Batch release testing imposed as a condition of registration
– Pharmacovigilance of biosimilars: Requirements of sponsors of biosimilars for post-registration pharmacovigilance
– Naming conventions for biosimilars: Includes guidance on:
- Australian Biological Names (ABN)
- Trade Names.
– Labels, product information (PI) and consumer medicine information (CMI) for biosimilars
- Identifies the requirements for the Product Information (PI) AND Consumer Medicine Information (CMI)
- Provides guidance on specific text to include in the PI for biosimilars.
– Appendix 1 – Suggested techniques for inclusion in comparability studies.