Adalimumab originator versus adalimumab biosimilars in inflammatory bowel disease in Australia

References

• Buchner AM, Schneider Y, Lichtenstein GR. Biosimilars in inflammatory bowel disease. Am J Gastroenterol. 2021;116:45–46.
   PubMedGoogle Scholar
• Therapeutic Goods Administration, Australian Government Department of Health. Biosimilar medicines regulation. [Internet] 2018 [cited 2021 Aug 16]; Available from: https://www.tga.gov.au/publication/biosimilar-medicines-regulation
   Google Scholar
• Bellinvia S, Fraser Cummings JR, Arden-Jones MR, et al. Adalimumab biosimilars in Europe: an overview of the clinical evidence. BioDrugs. 2019;33:241–253.
   PubMed Web of Science ®Google Scholar
• Danese S, Bonovas S, Peyrin-Biroulet L. Biosimilars in IBD: from theory to practice. Nat Rev Gastroenterol Hepatol. 2017;14(1):22–31.
   PubMed Web of Science ®Google Scholar
• Moorkens E, Godman B, Huys I, et al. The expiry of humira market exclusivity and the entry of adalimumab biosimilars in Europe: an overview of pricing and national policy measures. Front Pharmacol. 2020;11:591134.
   PubMed Web of Science ®Google Scholar
• Aladul MI, Fitzpatrick RW, Chapman SR. Impact of infliximab and etanercept biosimilars on biological disease-modifying anti-rheumatic drugs utilisation and NHS budget in the UK. BioDrugs. 2017;31(6):533–544.
   PubMed Web of Science ®Google Scholar
• NPS MedicineWise. Biologics, biosimilars and PBS sustainability. 2021 [ updated 2021 May 20; cited 2021 Aug20]. Available from: https://www.nps.org.au/news/biologics-biosimilars-and-pbs-sustainability
   Google Scholar
• Australian Government Department of Health. Biosimilar Awareness Initiative. 2021 [updated 2021 September 30; cited 2021Aug20]. Available from: https://www1.health.gov.au/internet/main/publishing.nsf/Content/biosimilar-awareness-initiative
   Google Scholar
• Fiorino G, Giraldi D, Correale C, et al. Biosimilars of adalimumab: the upcoming challenge in IBD. Expert Opin Biol Ther. 2019;19(10):1023–1030.
   PubMed Web of Science ®Google Scholar
• Pharmaceutic Benefits Scheme. Adalimumab pharmaceutical benefits scheme changes – 1 April 2021. Internet. Canberra: Australian Government Department of Health; 2021. cited 2021 Aug 12. Available from: https://www.pbs.gov.au/info/news/2021/03/adalimumab-pbs-changes-1-april-2021
   Google Scholar
• Hercogova J, Papp KA, Chyrok V, et al. AURIEL-Pso: a randomized, double-blind phase III equivalence trial to demonstrate the clinical similarity of the proposed biosimilar MSB11022 to reference adalimumab in patients with moderate-to-severe chronic plaque-type psoriasis. Br J Dermatol. 2020;182:316–326.
   PubMed Web of Science ®Google Scholar
• Wiland P, Jeka S, Dokoupilová E, et al. Switching to biosimilar SDZ-ADL in patients with moderate-to-severe active rheumatoid arthritis: 48-week efficacy, safety and immunogenicity results from the phase III, randomized, double-blind ADMYRA study. BioDrugs. 2020;34(6):809–823.
   PubMed Web of Science ®Google Scholar
• 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 Rheumatic Dis. 2017;76(10):1679–1687.
   PubMed Web of Science ®Google Scholar
• Weinblatt ME, Baranauskaite A, Niebrzydowski J, et al. Phase III randomised study of SB5, an adalimumab biosimilar versus reference adalimumab in patients with moderate-to-severe rheumatoid arthritis. Arthritis Rheumatol. 2018;70(1):40–48.
   PubMed Web of Science ®Google Scholar
• Mitrev N, Vande Casteele N, Seow CH, et al. Review article: consensus statements on therapeutic drug monitoring of anti-tumour necrosis factor therapy in inflammatory bowel diseases. Aliment Pharmacol Ther. 2017 Dec;46(11–12):1037–1053. DOI:10.1111/apt.14368.
   PubMed Web of Science ®Google Scholar
• Bhat S, Limdi JK, Cross RK, et al. Does similarity breed contempt? A review of the use of biosimilars in inflammatory bowel disease. Dig Dis Sci. 2021;66:2513–3532.
   PubMed Web of Science ®Google Scholar
• Zhao S, Chadwick L, Mysler E, et al. Review of biosimilar trials and data on adalimumab in rheumatoid arthritis. Curr Rheumatol Rep. 2018;20(10):1–10.
   Web of Science ®Google Scholar
• Ha CY, Kornbluth A A critical review of biosimilars in ibd: the confluence of biologic and drug development, regulatory requirements, clinical outcomes and big business. Inflammatory Bowel Disease 2016;22(10):p. 2513–2526
   Google Scholar
• Lukas M, Malickova K, Kolar M, et al. Switching from originator adalimumab to the biosimilar SB5 in patients with inflammatory bowel disease: short-term experience from a single tertiary clinical centre. J Crohn’s Colitis. 2020;14(7):915–919.
   Google Scholar
• St Clair-Jones A, Prignano F, Goncalves J, et al. Understanding and minimising injection-site pain following subcutaneous administration of biologics: a narrative review. Rheumatol Ther. 2020;7(4):741–757.
   PubMed Web of Science ®Google Scholar
• Bergman M, Patel P, Chen N, et al. Evaluation of adherence and persistence differences between adalimumab citrate-free and citrate formulations for patients with immune-mediated diseases in the United States. Rheumatol Ther. 2021 Mar;8(1):109–118.
   PubMed Web of Science ®Google Scholar
• NHS England. NHS set to save record £300 million on the NHS’s highest drug spend. [Internt] 2018 [cited 2021 Nov 20]; Available from: https://www.england.nhs.uk/2018/11/nhs-set-to-save-record-300-million-on-the-nhss-highest-drug-spend/
   Google Scholar
• Pharmaceutic Benefits Scheme. PBS expenditure and prescriptions report 1 July 2019 to 30 June 2020. Canberra: Australian Government Department of Health 2020 [cited 2021 Aug 16]. Available from: https://www.pbs.gov.au/info/statistics/expenditure-prescriptions/pb-expenditure-and-prescriptions-report-1-july-2019
   Google Scholar
• Danese S, Fiorino G, Michetti P Changes in biosimilar knowledge among European Crohn’s Colitis Organization [ECCO] members: an updated survey. Journal of Crohn’s and Colitis 2016;10(11):p. 1362–1365
   Google Scholar
• Sullivan E, Piercy J, Waller J, et al. Assessing gastroenterologist and patient acceptance of biosimilars in ulcerative colitis and Crohn’s disease across Germany. PLoS ONE. 2017;12(4):e0175826.
   PubMed Web of Science ®Google Scholar
• Peyrin-Biroulet L, Lonnfors S, Avedano L, et al. Changes in inflammatory bowel disease patients’ perspectives on biosimilars: a follow-up survey. United European Gastroenterol J. 2019;7(10):1345–1352.
   PubMed Web of Science ®Google Scholar