Expedited Pathways

Draft process flow of expedited pathway: reproduced from the TGA Presentation ‘Prescription Medicines MMDR Reforms Overview and Designation Process: Expedited Pathways for Prescription Medicines’, 14 October 2016 


One of the outcomes of the ‘Review of Medicines and Medical Devices (MMDR Review)’ is the adoption of expedited pathways for approval of prescription medicines in Australia.

The TGA proposes to adopt two expedited pathways for the registration of […]

Updated TGA Guideline on the Regulation of Biosimilars

The TGA has recently released their updated guidance on the ‘Regulation of biosimilar medicines’ v 2.0, Dec 2015. A few preliminary thoughts:

The section on Reference Medicines has been updated. In order to register a biosimilar in Australia the reference product must be a biological medicine which is registered in Australia on the basis of full quality, safety and efficacy data. The use of reference […]

Proposed Changes to Immunogenicity Requirements for Biopharmaceuticals (Part 1)

In light of experience, since the original guidance document was published in 2006, there are a number of changes under consideration in the draft guidance document ‘Guideline on Immunogenicity assessment of biotechnology-derived therapeutic proteins’[i].

Broadly these include:

More specific requirements for immunogenicity assays
Investigation into the clinical significance of immunogenicity
Risk-based approach to immunogenicity with requirements for both studies prior to registration plus studies post-registration
Nonclinical studies are recognised […]

CMC Development of Biosimilars


In order to establish biosimilarity to the innovator biopharmaceutical (reference product) it is necessary for the product to be highly comparable to the reference product from the region in which approval is ultimately sought.

A stepwise approach is recommended by firstly establishing that the CMC aspects are highly comparable to the reference product. For example:

The amino acid sequence of the biosimilar would be expected to […]

The Trans-Pacific Partnership and Biological Medicines

The Trans-Pacific Partnership (TPP) has reached agreement; consequently a major sticking point in relation to the period of data exclusivity for biological medicines has been overcome. The innovators of biological medicines were pushing for a 12 year data exclusivity period in-line with the US legislation. It is argued that this timeframe is required to recoup the major expense of funding the development of novel […]

Traversing the valley of death: regulatory challenges in the transition from discovery to development

The transition from drug discovery to drug development is aptly termed the ‘valley of death’. Its earned this name due to the difficult journey, and high failure rate, between these two major activities. This journey can be exacerbated if there is a cultural divide between discovery, which often occurs in an academic environment, and development, which occurs in a commercial one; two workplaces which […]