Australia doubles back on biosimilar naming conventions to follow WHO move

By Zachary Brennan contact

- Last updated on GMT

Australia is following the WHO's lead
Australia is following the WHO's lead
Australia’s TGA (Therapeutic Goods Administration) is shifting its stance on the way it plans to name biosimilars to keep the country more in line with the WHO’s (World Health Organization) proposed policies.

Until the WHO plan is finalized, the TGA says that it will use new trade names alongside the same biologic name as the reference product. For instance, a biosimilar to the reference product Neupogen filgrastim would be named 'tradename' filgrastim. The TGA has been approving biosimilars since 2010.

Background

The shift to follow the WHO comes as last summer the WHO released a new biologic qualifier (BQ) plan​ that would mean biosimilar names remain unique from their reference products.

Approved by the WHO’s INN (International Nonproprietary Name) Expert Group, the BQ system would use of an alphabetic code assigned at random to a biological active substance manufactured at a specified site. The BQ code, which will consist of four random letters, would not be part of the INN, which would still be selected under the same procedure.

Adoption of the BQ scheme, which is supported by US industry group BIO and USP​, would be funded by a single fee from each applicant, and involvement would be decided by an individual country’s regulatory authorities. The system would be used to complement an INN for a biological substance by uniquely identifying directly or indirectly the manufacturer and manufacturing site of the active substance in a biological product.

Australia

Originally in July 2013 the TGA published guidance on biosimilar naming based upon the combination of a WHO INN-issued biosimilar identifier with the Australian biological name (ABN). The TGA’s call for a distinctive nonproprietary identifier to be given to each biosimilar aligned the country with Japan, but created a situation in which the same biosimilar could potentially have different names in different markets, which could further add to the confusion around biosimilars.

But when in July 2014 the WHO published its new draft policy, which superseded the previous INN position on which the TGA policy was based, the TGA says it will now undertake a review of its policy.

As far as where industry stands, AbbVie, Genentech and Amgen are calling​ for new non-proprietary names for biosimilars in the US, while industry group GPhA and Novartis believe biologics and biosimilars should have the same INNs, like in Europe.

A GPhA spokesman told BioPharma-Reporter.com the group’s position has not changed since the WHO’s draft policy was released.

An Amgen spokeswoman, meanwhile, told us the company supports “distinguishable naming conventions for all biologics [that] will help strengthen the accuracy of tracing via post-marketing safety monitoring systems.”

And as far as the WHO, the spokeswoman added: “Amgen supports the overall direction the World Health Organization (WHO) is taking with regard to their proposed international non-proprietary naming (INN) policy for biologic medicines​.” 

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