Approval and use of biosimilar medicines in Australia is set to grow in the wake of changes affecting registration and market uptake of biosimilar medicines.
The Australian Government, recognising the growing role biosimilar medicines will play in providing treatment options to Australians in coming years, has launched an initiative aimed at improving awareness and confidence in biosimilar medicines amongst prescribers, pharmacists and patients in Australia. It has allocated $20 million to this initiative over a three year period.
In accordance with this approach, on 16 December 2015, the Therapeutic Goods Administration (TGA) released its updated guidelines on biosimilars, specifically referring to a number of European Medicines Agency (EMA) guidelines providing standards for quality, non-clinical and clinical data requirements for biosimilarity.
This followed the listing of Pfizer's biosimilar Inflectra (Infliximab) on the Pharmaceutical Benefits Scheme (PBS) on 1 December 2015.
Relevantly for sponsors of original biologic medicines, recent amendments have been made to the National Health Act in relation to the effect of a listing of biosimilar medicines on the PBS, a system that provides government subsided prescription medicines to Australians.
In particular, the pricing consequences of the listing of a biosimilar medicine on the PBS are now certain – a 16% price drop (from the subsidised price the government pays the sponsor) will occur on reference brands following the first listing of a biosimilar medicine on the PBS. This is consistent with the position arising on the first listing of a small molecule generic medicine.
The PBS listing of Inflectra brings a total of 9 biosimilar medicines approved for use in Australia, the following five of which are listed on the PBS:
Click here to view table.
The initiative will work in tandem with a move unprecedented globally by the Pharmaceutical Benefits Advisory Committee (PBAC), that gives Australian patients the option of substituting biologic medicines with a biosimilar medicine at a dispensary level where the biosimilar has been approved as a safe and effective substitution by the TGA and PBAC, and substitution is permitted by the prescriber (known as being “flagged”). This position is in line with generic medicine substitution. This does not mean that substitution will be automatic and doctors can determine the appropriate medicine to be dispensed (and not permit substitution).
However, a recent State Government Health Department tender has seen the listing of Inflectra and the reference product, Remicade, on its formulary with the recommendation that treatment naive patients be started on the biosimilar.
With the adoption of the updated guidelines for applications to register biosimilar medicines on the ARTG (Regulation of biosimilar medicines, December 2015), it is expected that the path to approval will be clearer.
The Guidelines include the following key updates in relation to the registration of a biosimilar medicine on the ARTG:
- Adoption of the following European guidelines on quality, and clinical and nonclinical data requirements:
- CHMP/437/04 Rev1: Guideline on similar biological medicinal products;
- EMA/CHPM/BWP247713/2012: Guideline on similar biological medicinal products containing biotechnology-derived proteins as active substance: quality issues (revision 1);
- EMEA/CHMP/BMWP/42832/2005 Rev 1: Guideline on similar biological medicinal products Containing Biotechnology-Derived Proteins as Active Substances: Non-clinical and Clinical Issues. Effective 1 July 2015;
- The reference medicine must be a biological medicine that:
- is registered in Australia based on full quality, safety and efficacy data;
- has been marketed in Australia for a substantial period (considered on a case-by-case basis);
- has a volume of marketed use so that there is a substantial body of acceptable data regarding the safety and efficacy for the approved indications;
or, if the reference medicine is not registered in Australia:
- approved for general marketing by a regulatory authority with similar scientific and regulator standards such as the EMA or US FDA; and
- a bridging study demonstrating that comparability studies are relevant to the Australian reference medicine must be provided (this can be abridged or omitted where evidence is included that the medicine is manufactured at a single site for global distribution);
- Active ingredients of biosimilar medicines will use the Australian biological name (without a specific biosimilar identifier suffix) while the WHO Programme on International Non-proprietary Names (INN) considers a naming convention for active ingredients of biological medicines.