Pharmacy Daily | Biologics and barcodes

THE Therapeutic Goods Administration (TGA) has published 34 submissions to its 'Nomenclature of biological medicines' consultation.

Opinions were divided, with a number focusing on the barcode option and others on the suffix option for the naming of biologics, both originator (or "reference") brands and their biosimilars.

The main problem with the nomenclature tradition is that, unlike with small molecule generic medicines which are identical molecules, albeit sometime with differing excipients, the "extreme complexity and large molecular size of biologic medicines means even minor differences between two similar biologics can cause unexpected reactions in patients," says Safe Biologics in its submission.

Safe Biologics is an alliance of around 15 medical and academic groups which have been working together on this issue.

"Additionally, biologics are extremely sensitive to changes in their manufacturing process, which has the potential to change how the medicine behaves in the body," the submission explained.

"A consistent and transparent naming system that clearly and distinctly identifies each individual product by manufacturer can help manage these risks and increase physician comfort with biosimilars."

Safe Biologics does not support the barcode option, where healthcare facilities, prescribers, and dispensers record information by scanning the barcode, but prefers the suffix option, where a "distinguishable suffix is added to the end of a shared root name".

Medicines Australia, the Pharmacy Guild and NPS MedicineWise all support the machine readable barcode option citing the value of being able to trace the product through the distribution chain and reduction of ambiguity and human error risks.

NPS was critical of the suffix option because it could identify a product as 'not the original' and undermine uptake and the equivalence messaging around biosimilars - see tga.gov.au.