Revised: 2 May 2014

Medicines

Biosimilars

A biosimilar medicine is a new biological product that is similar to another biological medicine that has been granted consent to be marketed in New Zealand (the biological reference).

The active substance of a biosimilar is similar, but not identical, to that of the biological reference. Approval is based on pharmacokinetic and pharmacodynamic studies as well as comparative clinical studies.

Data provided to support the application should show no important difference between biosimilar medicines and the biological reference in terms of efficacy and safety. However, consensus regarding the interchangeability of a biosimilar medicine and its reference product has yet to be reached. The prescribing physician should therefore take this into account when considering interchanging the medicines.

For more information see:

European guidance

FDA guidance

Medsafe Position on Biosimilars (Adobe PDF document 126KB)

Data sheets for biosimilars should include the following information:

  • if the product is known to be non-interchangeable, this should be clearly stated in the Description section
  • a statement in the Description section that the product is a biosimilar medicine. This should be followed by a statement that the prescribing physician should be involved in any decision regarding interchangeability (unless the product is known to be non-interchangeable), and a reference to this webpage for further information (www.medsafe.govt.nz/profs/RIss/Biosimilars.asp)
  • a reference to any further comparative information elsewhere in the datasheet (see below) should also be made at this point
  • information from clinical studies regarding the comparability of the product to the reference should be included in relevant sections
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