Biosimilars: is interchangeability the proof of the pudding?

Gregory T Moore and Charlotte Keung
Med J Aust 2021; 214 (3): . || doi: 10.5694/mja2.50912
Published online: 15 February 2021

While apparently non‐inferior to originator biologics, other factors need to be considered before switching

Biologic drugs are large monoclonal antibodies or genetically engineered proteins produced by live organisms. With highly specific targets, they have revolutionised the treatment of inflammatory, endocrine, and malignant conditions. However, these drugs are expensive, partly because of the complex and costly manufacturing processes required, partly because long periods of therapy are often needed.

  • 1 Monash Health, Melbourne, VIC
  • 2 Monash University, Melbourne, VIC


Competing interests:

Gregory Moore has received payment for advisory boards from AbbVie, BMS, Chiesi, Emerge, Gilead, Hospira, Janssen, Orphan, MSD, Pfizer, Shire, Takeda; speaker’s fees from AbbVie, Ferring, Janssen, Orphan, Pfizer, Roche, Shire, and Takeda; and research and educational support from AbbVie, Janssen, Pfizer, Shire, and Takeda.

  • 1. Australian Department of Health. Which biosimilar medicines are available in Australia? Updated 10 Sept 2020. (viewed Nov 2020).]
  • 2. Therapeutic Goods Administration (Australian Department of Health). Biosimilar medicines regulation, version 2.2. Apr 2018. (viewed Nov 2020).
  • 3. Park W, Hrycaj P, Jeka S, et al. A randomised, double‐blind, multicentre, parallel‐group, prospective study comparing the pharmacokinetics, safety, and efficacy of CT‐P13 and innovator infliximab in patients with ankylosing spondylitis: the PLANETAS study. Ann Rheum Dis 2013; 72: 1605–1612.
  • 4. Yoo DH, Hrycaj P, Miranda P, et al. A randomised, double‐blind, parallel‐group study to demonstrate equivalence in efficacy and safety of CT‐P13 compared with innovator infliximab when coadministered with methotrexate in patients with active rheumatoid arthritis: the PLANETRA study. Ann Rheum Dis 2013; 72: 1613–1620.
  • 5. Haifer C, Srinivasan A, An YK, et al. Switching Australian patients with moderate to severe inflammatory bowel disease from originator to biosimilar infliximab: a multicentre, parallel cohort study. Med J Aust 2021; 214: 128–133.
  • 6. Jørgensen KK, Olsen IC, Goll GL, et al. NOR‐SWITCH study group. Switching from originator infliximab to biosimilar CT‐P13 compared with maintained treatment with originator infliximab (NOR‐SWITCH): a 52‐week, randomised, double‐blind, non‐inferiority trial. Lancet 2017; 389: 2304–2316.
  • 7. Jørgensen KK, Goll GL, Sexton J, et al. Efficacy and safety of CT‐P13 in inflammatory bowel disease after switching from originator infliximab: exploratory analyses from the NOR‐SWITCH main and extension trials. BioDrugs 2020; 34: 681–694.
  • 8. Ye BD, Pesegova M, Alexeeva O, et al. Efficacy and safety of biosimilar CT‐P13 compared with originator infliximab in patients with active Crohn’s disease: an international, randomised, double‐blind, phase 3 non‐inferiority study. Lancet 2019; 393: 1699–1707.
  • 9. Ben‐Horin S, Yavzori M, Benhar I, et al. Cross‐immunogenicity: antibodies to infliximab in Remicade‐treated patients with IBD similarly recognise the biosimilar Remsima. Gut 2016; 65: 1132–1138.
  • 10. Goncalves J, Myung G, Park M, et al. SB5 shows cross‐immunogenicity to adalimumab but not infliximab: results in patients with inflammatory bowel disease or rheumatoid arthritis. Therap Adv Gastroenterol 2019; 12: 1756284819891081.
  • 11. Strik AS, van de Vrie W, Bloemsaat‐Minekus JPJ, et al. SECURE study group. Serum concentrations after switching from originator infliximab to the biosimilar CT‐P13 in patients with quiescent inflammatory bowel disease (SECURE): an open‐label, multicentre, phase 4 non‐inferiority trial. Lancet Gastroenterol Hepatol 2018; 3: 404–412.
  • 12. Australian Department of Health. Biosimilar uptake drivers. 2018. (viewed Nov 2020).
  • 13. Glintborg B, Loft AG, Omerovic E, et al. To switch or not to switch: results of a nationwide guideline of mandatory switching from originator to biosimilar etanercept. One‐year treatment outcomes in 2061 patients with inflammatory arthritis from the DANBIO registry. Ann Rheum Dis 2019; 78: 192–200.
  • 14. Lauret A, Moltó A, Abitbol V, et al. Effects of successive switches to different biosimilars infliximab on immunogenicity in chronic inflammatory diseases in daily clinical practice Semin Arthritis Rheum 2020; 50: 1449–1456.
  • 15. Zarrin AA, Bao K, Lupardus P, Vucic D. Kinase inhibition in autoimmunity and inflammation. Nat Rev Drug Discov 2021; 20: 39–63.


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