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    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


    Correspondence: gregory.moore@monash.edu
    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. https://www1.health.gov.au/internet/main/publishing.nsf/Content/biosimilar-which-medicines-are-available-in-australia (viewed Nov 2020).]
    • 2. Therapeutic Goods Administration (Australian Department of Health). Biosimilar medicines regulation, version 2.2. Apr 2018. https://www.tga.gov.au/publication/biosimilar-medicines-regulation (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. https://www.pbs.gov.au/general/biosimilars/biosimilar-uptake-drivers-q-and-a.pdf (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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      What are people saying on social networking sites about the Australian alcohol consumption guidelines?

      Benjamin C Riordan, Daniel T Winter, Paul S Haber, Carolyn A Day and Kirsten C Morley
      Med J Aust 2021; 214 (3): . || doi: 10.5694/mja2.50902
      Published online: 15 February 2021

      Posts provide valuable feedback during public consultation for health guidelines

      Guidelines provide important information on key health behaviours that can influence the population, with public consultation forming an important part of guideline development.1 Public consultation provides transparency, while improving the quality, legitimacy and acceptability of guidelines to the public.1 Although the public are encouraged to provide formal feedback, they may also discuss and provide valuable feedback on popular social networking sites such as Twitter and Reddit. Social networking sites are universal, with 5.8 million Australians using Twitter and 110 000 using Reddit each month.2 Given that a number of these posts are publicly available, they can be used to answer research questions and track health behaviours,3,4,5 and may be an informative source of feedback on health guidelines during public consultation.6


      • 1 University of Sydney, Sydney, NSW
      • 2 Royal Prince Alfred Hospital, Sydney, NSW


      Competing interests:

      No relevant disclosures.

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        Modelling the impact of relaxing COVID‐19 control measures during a period of low viral transmission

        Nick Scott, Anna Palmer, Dominic Delport, Romesh Abeysuriya, Robyn M Stuart, Cliff C Kerr, Dina Mistry, Daniel J Klein, Rachel Sacks‐Davis, Katie Heath, Samuel W Hainsworth, Alisa Pedrana, Mark Stoove, David Wilson and Margaret E Hellard
        Med J Aust 2021; 214 (2): . || doi: 10.5694/mja2.50845
        Published online: 1 February 2021

        Abstract

        Objectives: To assess the risks associated with relaxing coronavirus disease 2019 (COVID‐19)‐related physical distancing restrictions and lockdown policies during a period of low viral transmission.

        Design: Network‐based viral transmission risks in households, schools, workplaces, and a variety of community spaces and activities were simulated in an agent‐based model, Covasim.

        Setting: The model was calibrated for a baseline scenario reflecting the epidemiological and policy environment in Victoria during March–May 2020, a period of low community viral transmission.

        Intervention: Policy changes for easing COVID‐19‐related restrictions from May 2020 were simulated in the context of interventions that included testing, contact tracing (including with a smartphone app), and quarantine.

        Main outcome measure: Increase in detected COVID‐19 cases following relaxation of restrictions.

        Results: Policy changes that facilitate contact of individuals with large numbers of unknown people (eg, opening bars, increased public transport use) were associated with the greatest risk of COVID‐19 case numbers increasing; changes leading to smaller, structured gatherings with known contacts (eg, small social gatherings, opening schools) were associated with lower risks. In our model, the rise in case numbers following some policy changes was notable only two months after their implementation.

        Conclusions: Removing several COVID‐19‐related restrictions within a short period of time should be undertaken with care, as the consequences may not be apparent for more than two months. Our findings support continuation of work from home policies (to reduce public transport use) and strategies that mitigate the risk associated with re‐opening of social venues.

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        • 1 Burnet Institute, Melbourne, VIC
        • 2 University of Copenhagen, Copenhagen, Denmark
        • 3 Institute for Disease Modeling, Bellevue, WA, United States of America


        Correspondence: nick.scott@burnet.edu.au
        Acknowledgements: 

        We thank Allan J Saul, Angela Davis, Joseph Doyle, Sherrie Kelly and Suman Majumdar (Burnet Institute) for their contributions to parameter estimates, and additional members of the Institute for Disease Modelling team who contributed to the base Covasim model.

        Competing interests:

        No relevant disclosures.

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          Putting the “good” into Good Clinical Practice

          Tanya Symons, Steve Webb and John R Zalcberg
          Med J Aust 2021; 214 (2): . || doi: 10.5694/mja2.50908
          Published online: 1 February 2021

          Current Good Clinical Practice guidelines are bureaucratic and should align with less burdensome examples of international trial policy

          Clinical trials must be conducted in ways that protect participants and produce reliable results. Both are central tenets of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) Good Clinical Practice (GCP) guideline.1 The ICH GCP guideline was developed to harmonise the conduct of trials across world regions and, since the mid‐1990s, its core principles have provided the bedrock for trial conduct. However, the devil is in the detail and, in the case of the ICH GCP guideline, that detail (and the interpretation of each word) has far‐reaching consequences.


          • 1 University of Sydney, Sydney, NSW
          • 2 Royal Perth Hospital, Perth, WA
          • 3 Monash University, Melbourne, VIC


          Correspondence: tanya.symons@sydney.edu.au
          Competing interests:

          No relevant disclosures.

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            Unprofessional behaviour in Australian hospitals

            Anthony Scott and Danny Hills
            Med J Aust 2021; 214 (1): . || doi: 10.5694/mja2.50891
            Published online: 18 January 2021

            Inappropriate behaviour harms health workers and patients, and evidence‐based solutions are needed

            Health care is the largest employment sector in Australia, more than 1.7 million workers (14% of all employees).1 Incivility, bullying, aggression, and negative workplace cultures seem endemic and have repeatedly been associated with poor workforce and clinical outcomes, but high quality evaluation of interventions for eliminating these behaviours are rare.2,3,4


            • 1 Melbourne Institute: Applied Economic and Social Research, Melbourne, VIC
            • 2 Federation University Australia, Ballarat, VIC


            Correspondence: a.scott@unimelb.edu.au
            Competing interests:

            No relevant disclosures.

            • 1. Australian Bureau of Statistics. 6291.0.55.003. Labour force, Australia, detailed (May 2020). June 2020. https://www.abs.gov.au/statistics/labour/employment-and-unemployment/labour-force-australia-detailed/may-2020 (viewed Sept 2020).
            • 2. Westbrook J, Sunderland N, Atkinson V, et al. Endemic unprofessional behaviour in health care: the mandate for a change in approach. Med J Aust 2018; 209: 380–381. https://www.mja.com.au/journal/2018/209/9/endemic-unprofessional-behaviour-health-care-mandate-change-approach
            • 3. Mannion R, Davies H. Understanding organisational culture for healthcare quality improvement. BMJ 2018; 363: k4907.
            • 4. Choo EK, Byington CL, Johnson NL, et al. From #MeToo to #TimesUp in health care: can a culture of accountability end inequity and harassment? Lancet 2019; 393: 499–502.
            • 5. Westbrook J, Sunderland N, Li L, et al. The prevalence and impact of unprofessional behaviour among hospital workers: a survey in seven Australian hospitals. Med J Aust 2021; 214: 31–37.
            • 6. Hills DJ, Joyce CM, Humphreys JS. A national study of workplace aggression in Australian clinical medical practice. Med J Aust 2012; 197: 336–340. https://www.mja.com.au/journal/2012/197/6/national-study-workplace-aggression-australian-clinical-medical-practice
            • 7. Hills D, Lam L, Hills S. Workplace aggression experiences and responses of Victorian nurses, midwives and care personnel. Collegian 2018; 25: 575–582.
            • 8. Fear NT, Seddon R, Jones N, et al. Does anonymity increase the reporting of mental health symptoms? BMC Public Health 2012; 12: 797.
            • 9. Edwards P, Roberts I, Clarke M, et al. Methods to increase response to postal and electronic questionnaires. Cochrane Database Syst Rev 2009; MR000008.
            • 10. Joyce CM, Scott A, Jeon SH, et al. The “Medicine in Australia: Balancing Employment and Life (MABEL)” longitudinal survey: protocol and baseline data for a prospective cohort study of Australian doctors’ workforce participation. BMC Health Serv Res 2010; 10: 50.
            • 11. Saini V, Garcia‐Armesto S, Klemperer D, et al. Drivers of poor medical care. Lancet 2017; 390: 178–190.

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              Outcomes for patients with COVID‐19: known knowns, known unknowns, and unknown unknowns

              Mervyn Singer
              Med J Aust 2021; 214 (1): . || doi: 10.5694/mja2.50890
              Published online: 18 January 2021

              Adequate capacity — beds, equipment, consumables, and, crucially, trained personnel — is needed to cope with a surge of critically ill patients

              In this issue of the MJA, Burrell and his co‐authors report on the management and outcomes of patients with coronavirus disease 2019 (COVID‐19) admitted to Australian intensive care units (ICUs) during February–June 2020.1 The ICU mortality rate was impressively low (22% for patients requiring mechanical ventilation, 5% for those who did not). Given the excellent quality of care, it is worth exploring other reasons for this low mortality.

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              • Bloomsbury Institute of Intensive Care Medicine, London, The United Kingdom


              Correspondence: m.singer@ucl.ac.uk
              Competing interests:

              I was involved with UCL, the UCL Hospitals NHS Foundation Trust, and Mercedes F1 in the development of a CPAP device (UCL Ventura) for use in patients with COVID‐19 on a not‐for profit, humanitarian basis.

              • 1. Burrell AJC, Pellegrini B, Salimi F, et al. Outcomes for patients with COVID‐19 admitted to Australian intensive care units during the first four months of the pandemic. Med J Aust 2021; 214: 23–30.
              • 2. Singer M, Shipley R, Baker T, et al. The UCL Ventura CPAP device for COVID‐19. Lancet Respir Med 2020; 8: 1076–1078.
              • 3. Richards‐Belle A, Orzechowska I, Gould DW, et al. ICNARC COVID‐19 Team. COVID‐19 in critical care: epidemiology of the first epidemic wave across England, Wales and Northern Ireland. Intensive Care Med 2020; 46: 2035–2047.
              • 4. Doidge JC, Mouncey PR, Thomas K, et al. Trends in intensive care for patients with COVID‐19 in England, Wales and Northern Ireland [preprint]; version 1, 10 Aug 2020. Preprints 2020; https://doi.org/10.20944/preprints202008.0267.v1.
              • 5. Intensive Care National Audit and Research Centre. ICNARC report on COVID‐19 in critical care: England, Wales and Northern Ireland, 13 November 2020. https://www.icnarc.org/DataServices/Attachments/Download/6167f9f7-ea25-eb11-912b-00505601089b (viewed Nov 2020).
              • 6. Helms J, Tacquard C, Severac F, et al. CRICS TRIGGERSEP Group (Clinical Research in Intensive Care and Sepsis Trial Group for Global Evaluation and Research in Sepsis). High risk of thrombosis in patients with severe SARS‐CoV-2 infection: a multicenter prospective cohort study. Intensive Care Med 2020; 173: 4030–4010.
              • 7. Ackermann M, Verleden SE, Kuehnel M, et al. Pulmonary vascular endothelialitis, thrombosis, and angiogenesis in Covid‐19. N Engl J Med 2020; 383: 120–128.
              • 8. Horby P, Lim WS, Emberson JR, et al; RECOVERY Collaborative Group. Dexamethasone in hospitalized patients with COVID‐19: preliminary report [preprint]; version 1, 22 June 2020. MedRxiv 2020; https://www.medrxiv.org/content/10.1101/2020.06.22.20137273v1 (viewed Nov 2020).
              • 9. Johns Hopkins Center for Systems Science and Engineering. COVID‐19 dashboard. https://coronavirus.jhu.edu/map.html (viewed Nov 2020).
              • 10. Johnson SU, Ebrahimi OV, Hoffart A. PTSD symptoms among health workers and public service providers during the COVID‐19 outbreak. PLoS One 2020; 15: e0241032.
              • 11. Shechter A, Diaz F, Moise N, et al. Psychological distress, coping behaviors, and preferences for support among New York healthcare workers during the COVID‐19 pandemic. Gen Hosp Psychiatry 2020; 66: 1–8.
              • 12. Holton S, Wynter K, Trueman M, et al. Psychological well‐being of Australian hospital clinical staff during the COVID‐19 pandemic. Aust Health Rev 2020; https://doi.org/10.1071/AH20203 [online ahead of print].

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                A New Year, the top research articles, and a call to deliver a “net zero” Australian health care system by 2040

                Nicholas J Talley
                Med J Aust 2021; 214 (1): . || doi: 10.5694/mja2.50896
                Published online: 18 January 2021

                As we all look forward to 2021 after a horror year, the MJA will continue to work to cement its status as a highly influential top‐tier journal

                Welcome to the MJA in 2021. Many will be pleased 2020 is finally over and will be looking forward to a better year.1,2 There are hopeful signs. The public health response to the coronavirus disease 2019 (COVID‐19) pandemic across Australia has been exemplary to date,3,4 and while challenges remain, multiple vaccines have been successful in phase 3 trials and vaccination is anticipated to commence in Australia soon.5 The United States presidential election is over after a very prolonged dispute, and for many this is a relief. I leave it up to the historians to debate how a US administration could fail so spectacularly in the public health response to a pandemic, but wonder if the necessary lessons will be learned globally before the next major infectious diseases outbreak, the risk of which continues to increase with a warming planet.6 The dire impact of climate change on health, including mortality, appears to be being taken more seriously in the United Kingdom, Europe and, at last, the US, although Australia disappointingly remains a laggard for now.6,7

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                • Medical Journal of Australia


                Correspondence: ntalley@mja.com.au
                Competing interests:

                A complete list of my conflict of interest disclosures is available at https://www.mja.com.au/journal/staff/editor‐chief‐professor‐nick‐talley.

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                  PPE for your mind: a peer support initiative for health care workers

                  Tahnee L Bridson, Kym Jenkins, Kieran G Allen and Brett M McDermott
                  Med J Aust 2021; 214 (1): . || doi: 10.5694/mja2.50886
                  Published online: 18 January 2021

                  Peer support initiatives can help health professionals experiencing mental health and wellbeing challenges during the COVID‐19 pandemic and beyond

                  The coronavirus disease 2019 (COVID‐19) pandemic has placed the health care workforce under an unprecedented level of stress. No area of the health workforce is immune to COVID‐19‐related changes to usual work practices. The impact of this acute stress has occurred in the context of a health care profession that was already struggling with major work‐related challenges including anxiety, depression, secondary trauma, compassion fatigue and burnout. Importantly, these issues may have been exacerbated by the COVID‐19 pandemic due to the direct consequences of health care workers being infected, and the indirect consequences of the economic impact on their families and friends, the rigours of lockdown and the adverse effects on health and wellbeing felt across all aspects of society.

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                  • 1 Hand‐n‐Hand Healthcare Workers Peer Support Network, Cairns, QLD
                  • 2 Sunshine Coast Mental Health and Addiction Services, Sunshine Coast, QLD
                  • 3 Council of Presidents of Medical Colleges, Canberra, ACT
                  • 4 Monash Health, Melbourne, VIC
                  • 5 College of Medicine and Dentistry, James Cook University, Townsville, QLD


                  Correspondence: handnhandAU@gmail.com
                  Acknowledgements: 

                  We thank the many health care professionals who have enthusiastically supported the Hand‐n‐Hand initiative from its humble beginnings, those who have volunteered to support their colleagues during these challenging times and those who have helped to promote the importance of peer support in the health care sector.

                  Competing interests:

                  We are all founding members of the Hand‐n‐Hand peer support initiative. Kym Jenkins and Brett McDermott are also members of the #MindingCOVID writing group, which has provided resources for Hand‐n‐Hand.

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                    COVID‐19 and residential aged care: priorities for optimising preparation and management of outbreaks

                    Georgia E Aitken, Alice L Holmes and Joseph E Ibrahim
                    Med J Aust 2021; 214 (1): . || doi: 10.5694/mja2.50892
                    Published online: 18 January 2021

                    Recommendations to guide residential aged care facilities in preparing for and managing infectious disease outbreaks

                    The coronavirus disease 2019 (COVID‐19) pandemic is devastating the residential aged care facility (RACF; eg, care homes, nursing homes, long term care) population. Globally, older people living in RACFs comprise almost half (47%) of all deaths from COVID‐19,1 which now exceeds 1.4 million deaths (at 27 November 2020).2

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                    • 1 Victorian Institute of Forensic Medicine, Melbourne, VIC
                    • 2 Queen Elizabeth Centre, Ballarat, VIC


                    Correspondence: Joseph.Ibrahim@monash.edu
                    Acknowledgements: 

                    This work was supported by the Ballarat Health Service and the Department of Forensic Medicine, Monash University. None of the funders influenced the design, methods, subject recruitment, data collection, analysis or preparation of the article. We thank all the medical practitioners and nurses who participated in this study at short notice, and Safer Care Victoria for hosting and Ballarat Health Service for supporting Joseph Ibrahim’s sabbatical leave.

                    Competing interests:

                    No relevant disclosures.

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                      Health and climate change MJA–Lancet Countdown report: Australia gets another failing grade in 2020 but shows signs of progress

                      Nicholas J Talley, Fiona J Stanley, Tamara Lucas and Richard C Horton
                      Med J Aust 2021; 214 (2): . || doi: 10.5694/mja2.50895
                      Published online: 21 December 2020

                      At the end of 2019 and into 2020, catastrophic fires in Australia consumed homes, lives, wildlife and land. Just as the fires subsided, Australia, like the rest of the world, faced another emergency — the COVID‐19 pandemic.1 It is instructive to reflect on lessons from the health disasters of the past year.

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                      • 1 University of Newcastle, Newcastle, NSW
                      • 2 Editor‐in-Chief, Medical Journal of Australia, Sydney, NSW
                      • 3 Telethon Kids Institute, Perth, WA
                      • 4 University of Western Australia, Perth, WA
                      • 5 Executive Editor, The Lancet, London, UK
                      • 6 Editor‐in-Chief, The Lancet, London, UK


                      Competing interests:

                      A complete list of Nick Talley’s disclosures is available at https://www.mja.com.au/journal/staff/editor-chief-professor-nick-talley.

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