Adalimumab resources and clinical information for healthcare professionals
Educational resources for healthcare professionals
Educational resources about biologics and biosimilars are available from various sources. More resources will be available over the coming weeks to support the introduction of Amgevita to New Zealand. We will update this section with links to new resources as they become available.
Amgen website HCP portal (Register page)(external link)
He Ako Hiringa: Transition to Amgevita (long form article)(external link)
He Ako Hiringa: Adalimumab Q&A(external link)
He Ako Hiringa: Humira to Amgevita - Experience from over the ditch (Webinar)(external link)
He Ako Hiringa: biologics resource hub(external link)
Read the full decision to widen access and award principal supply for adalimumab (Amgevita)
Introduction to biological medicines – He Ako Hiringa(external link)
A series of videos to provide a quick introduction to using biosimilars (He Ako Hiringa)
More about biological and biosimilar medicines
Biosimilars: The future of prescribing biological medicines – BPACnz(external link)
Biological and biosimilar medicines – Pharmac website
Safety and efficacy of Amgevita
Medsafe approval for Amgevita in New Zealand
Medsafe, the New Zealand Medicines and Medical Devices Safety Authority, approves medicines for use in New Zealand and evaluates all biosimilar medicines before they are funded in New Zealand.
To ensure a biosimilar works and is safe, Medsafe examines the information about the quality of the biosimilar, the evidence of how it was developed and how patients respond to it. This ensures a biosimilar has no important differences from the reference biologic. As Amgevita is Medsafe approved, it has gone through this review to check it is as effective and safe as Humira.
Read more about how Medsafe assesses biosimilar medicines(external link)
Amgevita data sheet – Medsafe website [PDF](external link)
International usage of Amgevita
Amgevita is used extensively in other countries and has been available in countries throughout Europe since 2017. This availability is based on the evidence of Amgevita’s biosimilarity to Humira with respect to comparative pharmacodynamic, pharmacokinetic and toxicology data.
Amgevita is also approved for use by the FDA in the United States, by Health Canada for use in Canada, the EMA in Europe, and the TGA in Australia.
New Zealand clinical experts are supportive of this change
We received advice from clinical experts who treat people with adalimumab and experts who critically appraise the strength and quality of evidence for new treatments.
Clinical advisors looked at the clinical evidence for biosimilar adalimumab, and Amgevita. Details of what was discussed by clinical experts can be found in the full records of those meetings:
- Pharmacology and Therapeutics Advisory Committee record (November 2020) [PDF, 636 KB]
- Dermatology and Ophthalmology Subcommittees record (October 2020) [PDF, 27 KB]
- Gastrointestinal Subcommittee record (October 2020) [PDF, 20 KB]
- Rheumatology Subcommittee record (October 2020) [PDF, 22 KB]
We also received advice regarding the changes to Special Authority access and communication activities to support awareness and implementation of the changes to adalimumab treatment. You can find more details of what was discussed by our clinical experts in the full records of those meetings: