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 […]

By |January 22nd, 2016|Uncategorized|0 Comments

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 […]

By |November 26th, 2015|Uncategorized|0 Comments

Approval of Infliximab Biosimilar in Australia

Registration of Hospira’s infliximab biosimilar, Inflectra, marks the first approval of a biosimilar monoclonal antibody by the Therapeutic Goods Administration. In order to achieve this approval Inflectra has demonstrated that it is biosimilar to the blockbuster drug, Remicade.

The PBAC subsequently listed Inflectra for the same indications as Remicade which is used in the treatment […]

By |August 24th, 2015|Biosimilars, Uncategorized|0 Comments

Does the benefit of the medicine outweigh the risk?

It was only after I started working in drug regulation that I fully appreciated the role of risk/benefit analysis for medicines. I thinks it’s a testimony to the skill of the regulators that balancing the benefit of a medicine against the risk has been performed so well that, as a consumer, I expected any […]

By |August 29th, 2014|Uncategorized|0 Comments