4 July 2018 - PBAC to consult with Medicines Australia on the possible withdrawal of the TGA-PBAC parallel process for a submission for a new biosimilar medicine.

The PBAC was requested to consider a revised approach to considering brand equivalence/substitution for biosimilar medicines in March 2018. It is unclear who made the request.

The Committee also considered supporting the Department to improve the efficient use of HTA resources in deciding that biosimilar submissions not be lodged via the TGA-PBAC parallel process.

It has been three years since the PBAC developed its position on the handling of submissions for biosimilar medicines. The Committee noted that many aspects regarding biosimilar medicines have changed/evolved.

The PBAC has advised that the following revised considerations will be used to inform the formation of its advice on brand equivalence (‘a’ flagged) of biosimilars with the reference brand:

• The TGA has determined that the product is a biosimilar of the reference medicine as evidenced by ARTG registration documentation;
  
• Availability of supportive data relating to the effects of switching between the reference product and the biosimilar product/s; and
  
• Practical considerations relating to substitution by the pharmacist at the point of dispensing. This includes strength of formulation, number of units per pack and maximum quantities between the brands, which may make substitution at the pharmacy level difficult from a practical perspective.
  

The Committee notes that the TGA cannot make a determination of biosimilarity if concerning evidence exists relating to differences in efficacy or safety between a biosimilar and its reference medicine/s.

The PBAC agreed to remove from the original considerations for advising on brand equivalence between a biosimilar medicine and its reference medicine/s, as these considerations are addressed by the evaluation conducted by the TGA.

The PBAC therefore concluded that the outcome of the TGA Delegate’s consideration were essential to the consideration of any biosimilar submission from the time of making the application.

The PBAC was of the view that based on the revised considerations, TGA-PBAC parallel processing should not be made available for proposed biosimilar medicines (i.e. yet to be determined by the TGA).

The PBAC noted that the parallel process arrangement was originally established within an agreement with Medicines Australia, so this change to the process will require consultation.

Read PBAC Public Summary Document