The regulatory body for approval of medicines in New Zealand is the New Zealand Medicines and Medical Devices Safety Authority (Medsafe). The agency is responsible for the regulation of medicines and medical devices in New Zealand, ensuring that medicines and medical devices are acceptably safe.
Medsafe defines a biosimilar as 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).
Medsafe has stated that approval of a biosimilar medicine is based on non-clinical studies (pharmacokinetic and pharmacodynamic studies) as well as comparative human clinical studies. Data provided to support the application should show no important difference between the biosimilar and the reference product 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.
Medsafe does not cite any specific New Zealand guidelines for biosimilars, but refers biosimilars manufacturers to both the US Food and Drug Administration draft guidelines and the European Medicines Agency guidelines for more information.
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Source: www.gabionline.net
