CLASStime: Transition to adalimumab biosimilar

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CLASStime: Transition to adalimumab biosimilar

Pharmacy Today

Pharmacy Today team

CLASS Mar 22

Biological medicines have markedly changed the prognoses for many chronic and disabling inflammatory and immunological conditions and cancers. Their use in New Zealand is increasing and, as patents expire on reference or originator “biologics”, the opportunity arises for competitor manufacturers to list biosimilars – highly similar versions of approved biological medicines.1,2


1. bpacnz. Biosimilars: the future of prescribing biological medicines. 31 January 2020.

2. He Ako Hiringa. Biosimilars: A promising new era. Bulletin 7, 27 September 2021.

3. Pharmac. Decision to widen access to adalimumab and award Principal Supply. 17 November 2021.

4. Pharmac. Proposal to widen access to adalimumab and award Principal Supply. 26 August 2021.

5. Pharmac. Adalimumab (Humira): Alternative brand access.

6. Pharmac. Request for Proposals – Supply of Adalimumab. 9 March 2021.

7. Kurki P, Barry S, Bourges I, et al. Safety, Immunogenicity and interchangeability of biosimilar monoclonal antibodies and fusion proteins: A regulatory perspective. Drugs 2021;81(16):1881–96.

8. Cohen S, Genovese MC, Choy E, et al. Efficacy and safety of the biosimilar ABP 501 compared with adalimumab in patients with moderate to severe rheumatoid arthritis: a randomised, double-blind, phase III equivalence study. Ann Rheum Dis 2017 Oct;76(10):1679–87.

9. Papp K, Bachelez H, Costanzo A, et al. Clinical similarity of biosimilar ABP 501 to adalimumab in the treatment of patients with moderate to severe plaque psoriasis: A randomized, double-blind, multicenter, phase III study. J Am Acad Dermatol 2017 Jun;76(6):1093–1102.

10. NPS MedicineWise. RADAR. Adalimumab biosimilars now PBS-listed. 21 April 2021.

11. Australian Government, Department of Health. Therapeutic Goods Administration. Australian Public Assessment Report for Adalimumab. June 2018.

12. Pharmac. Record of the New Zealand Pharmacology and Therapeutics Advisory Committee meeting. 12 and 13 November 2020.

13. Pharmac. Adalimumab (Amgevita): Information for health care professionals.

14. Pharmac. Amgevita access criteria.

15. New Zealand Formulary. Guidance on medicines use: Biological and biosimilar medicines.

16. The European Medicines Agency and the European Commission. Biosimilars in the EU: Information guide for healthcare professionals. © EMA, 2019.

17. bpacnz. The nocebo effect: what it is, why is it important and how can it be reduced? 30 August 2019.

18. Petrie K. Legendary Conversations (podcast). Episode One: Initiating new medicines (part 1). He Ako Hiringa. 11 October 2021.

19. He Ako Hiringa. Starting a medicine? Accentuate the positive. Bulletin 9, 26 November 2021.

20. Health Quality & Safety Commission New Zealand. Three steps to better health literacy – a guide for health care professionals. 18 November 2021.

21. Amgen (New Zealand) Limited. Launch mailer (PDF): What's behind Amgevita makes the difference. 20 January 2022. Accessed February 2022.

22. Medsafe. New Zealand data sheet. Amgevita. Available online at

23. Barbier L, Ebbers HC, Declerck P, et al. The efficacy, safety, and immunogenicity of switching between reference biopharmaceuticals and biosimilars: A systematic review. Clin Pharm Ther 2020;108(4):734–55.

24. Dörner T, Kay J. Biosimilars in rheumatology: current perspectives and lessons learnt. Nat Rev Rheumatol 2015;11:713–24.

25. Medsafe. Biosimilars. 2014. Available at: Accessed December 2021.