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Consultation: Nomenclature of Biological Medicines

2 July 2017

This consultation closed on 8 September 2017

The TGA sought comments from interested parties on proposed options on whether there is a need in Australia for additional naming requirements for biological medicines as a way of strengthening traceability and pharmacovigilance.

Consultation documents

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Timetable

Document released for consultation on 28 July 2017.

Interested parties should respond by close of business 8 September 2017.

Feedback will be released following consideration of submissions. (See 'What will happen').

About the consultation

  • The active substances of biological medicines can be large complex molecules and the demonstration of similarity between a biosimilar and a reference medicine can be challenging. This has led to concerns that unknown adverse events may arise from switching a patient between innovator and biosimilar products arising from immune-mediated reactions that have not been observed for the reference medicine. To date, such events have largely not been evident.
  • To allow investigation into adverse events when they occur, accurate information about exactly which biological medicine was involved must be captured.
  • There is no internationally agreed naming convention for a subclass of biological medicines referred to as biosimilars.
  • Given international developments for naming of biological medicines, the TGA now intends to consult on whether there is a need in Australia for additional naming requirements.

Background

A biological medicine is a medicine that contains one or more active substances made by or derived from a biological source rather than a synthetic chemical source.

A biosimilar medicine is a version of an already registered biological medicine (the innovator or reference medicine) that has demonstrated sufficient similarity to the reference medicine to ensure that patients taking the biosimilar medicine are not exposed to unexpected clinical consequences.

The active substance of a biosimilar and that of the innovator or reference medicine are manufactured to be highly similar and this is assessed by the TGA. TGA assesses the differences where they exist so that patients are not exposed to a product with unexpected clinical consequences.

Government is committed to implementing a biosimilar medicines uptake policy. Biosimilar medicines provide an opportunity to reduce the cost to Government of subsidising expensive biological medicines. The Biosimilar Awareness Initiative was announced in May 2015. The aim of the Initiative is to support awareness of, and confidence in, the use of biosimilar medicines for healthcare professionals and consumers.

Once a medicine is approved, pharmacovigilance by the TGA continues to monitor and evaluate the safety and efficacy profile of the medicine, for example through collecting reports of adverse events.

For biological medicines, concerns have been raised that currently unknown adverse events may arise from switching patients from an innovator drug to its biosimilar product. To date, these events have largely not been evident despite specific studies for particular biological medicines/biosimilars having been undertaken to monitor for such effects.

There is no internationally agreed naming convention for biosimilars. Currently, Australia is in line with the European approach whereby the active ingredient in a biosimilar medicine and its reference medicine are given the same International Non-proprietary Name (INN). The US FDA has recently announced its intention to require the non-proprietary name of a biological medicine to carry a four-letter suffix so that the reference product and biosimilar versions of the reference product can be distinguished.

Given international developments for naming of biosimilars and biological medicines, the TGA is now consulting on whether there is a need in Australia for additional naming requirements.

Submissions

Submissions may be provided on the proposed options stated in the consultation paper on naming of biological medicines, and possible impact as a result of the proposed change on you (these may be financial or non-financial). If possible, please attempt to quantify these costs and benefits. This is important - the TGA is required to quantify the regulatory impact (burden and/or savings) of any proposed changes.

Enquiries

Any questions relating to submissions should be directed to the Biological Science Section by email to bloodandtissues@tga.gov.au or by telephone to 1800 678 799.

What will happen

All submissions will be placed on the TGA Internet site unless marked confidential or indicated otherwise in the submission cover sheet (see Privacy information).

Submissions will be reviewed by the TGA and published on the TGA Internet website: feedback on submissions will be provided through the TGA Internet site at Public Submissions on Scheduling Matters.

Privacy information

  • The TGA collects your personal information in this submission in order to:
    • contact you if the TGA wants to seek clarification of issues raised in your submission or to check whether you consent to certain information that you have provided being made publicly available.
    • help provide context about your submission (e.g. to determine whether you are an individual or a director of a company or representing an interest group).
  • The TGA will disclose your name and (if applicable) your designation/work title on the TGA Internet site (i.e. make this information publicly available) if you consent to the publication of your name on the TGA Internet site (please complete the cover sheet).
  • Any text within the body of your submission that you want to remain confidential should be clearly marked 'IN CONFIDENCE'.
  • Please do not include personal information about other individuals in the body of your submission. Personal information in this context means information or an opinion about an individual whose identity is apparent, or can reasonably be ascertained, from the information or opinion.