This Guidelines in Practice animation has been commissioned and funded by Napp Pharmaceuticals Limited and developed in partnership with Guidelines in Practice. Napp Pharmaceuticals Limited suggested the topic for the animation, worked with MGP Ltd to choose and commission the presenter, and approved all materials related to the animation. The views and opinions expressed in the animation are not necessarily those of Guidelines in Practice, its publisher, adviser, or advertisers. 

Biologic medicines have transformed care for a number conditions and are now an important part of the treatment received by many patients.

Many biologics are now beginning to come off patent, which has led to the development of copies, similar to generics for conventional medicines that are known as biosimilars.

Watch this short animation, presented by Dr Paul Cornes, to learn about:

  • the opportunities that are presented by biosimilars
  • how biosimilars are approved and regulated
  • the impact that biosimilars have had on transforming care
  • how to access support and guidance on the use of biosimilars.

 

References

  1. World Health Organization. Global status report on noncommunicable diseases. WHO, 2014. Available at: www.who.int/nmh/publications/ncd-status-report-2014/en/ (accessed 28 March 2018).
  2. World Health Organization. Noncommunicable diseases—fact sheet. WHO, June 2017. Available at: www.who.int/mediacentre/factsheets/fs355/en/ (accessed 28 March 2018).
  3. NHS England. What is a biosimilar medicine? NHS England, 2015. Available at: www.england.nhs.uk/wp-content/uploads/2015/09/biosimilar-guide.pdf 
  4. European Medicines Agency. Biosimlars in the EU—information guide for healthcare professionals. EMA, 2017. Available at: www.ema.europa.eu/docs/en_GB/document_library/Leaflet/2017/05/WC500226648.pdf 
  5. US Department of Health and Human Services Food and Drug Administration. Guidance for industry—statistical approaches to establishing bioequivalence. FDA, 2001. Available at: www.fda.gov/downloads/drugs/guidances/ucm070244.pdf 
  6. International Council for Harmonisation of Technical Requirements for Human Use. ICH Harmonised tripartite guideline—comparability of biotechnological/biological products subject to changes in their manufacturing process. ICH, 2004. Available at: www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Quality/Q5E/Step4/Q5E_Guideline.pdf 
  7. QuintilesIMS. Global oncology trend report—a review of 2015 and outlook to 2020. IMS, 2016. Available at: www.iqvia.com/-/media/iqvia/pdfs/institute-reports/global-oncology-trend-report-2016.pdf
  8. European Medicines Agency. Guideline on similar biological medicinal products. EMA, 2014. Available at: www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2014/10/WC500176768.pdf 
  9. van den Hoven A. Biosimilar medicines clinical use: an experience based-EU perspective. FDA presentation, 13 July 2017, Washington DC, USA.
  10. Gascón P, Tesch H, Verpoort K et al. Clinical experience with Zarzio® in Europe: what have we learned? Support Care Cancer 2013; 21: 2925–2932.
  11. PHARMAC. Biosimilar filgrastim, more for less—the biosimilar filgrastim story. www.pharmac.govt.nz/about/annual-review/2014/biosimilar-filgrastim/ (accessed 28 March 2018).
  12. NICE. Erythropoiesis-stimulating agents (epoetin and darbepoetin) for treating anaemia in people with cancer having chemotherapy. NICE Technology Appraisal 323. NICE, 2014. Available at: guidance.nice.org.uk/TA323 
  13. NICE. Infliximab, adalimumab and golimumab for treating moderately to severely active ulcerative colitis after the failure of conventional therapy. NICE Technology Appraisal 329. NICE, 2015. Available at: guidance.nice.org.uk/TA329
  14. Ebbers H, Muenzberg M, Schellekens H et al. The safety of switching between therapeutic proteins. Expert Opin Biol Ther 2012; 12 (11): 1473–1485.
  15. Inotai, A, Prins C, Csanádi M, et al. Is there a reason for concern or is it just hype?—A systematic literature review of the clinical consequences of switching from originator biologics to biosimilars. Expert Opin Biol Ther 2017; 17 (8): 915–926.
  16. Cohen H, Blauvelt A, Rifkin R et al. Switching reference medicines to biosimilars: a systematic literature review of clinical outcomes. Drugs 2018; 78: 463–478.
  17. Kurki P, van Aerts L, Wolff-Holz E et al. Interchangeability of biosimilars: a European perspective. BioDrugs 2017; 31 (2): 83–91.
  18. Weise M, Kurki P, Wolff-Holz E et al. Biosimilars: the science of extrapolation. Blood 2014; 124 (22): 3191–3196.
  19. Russell R, Irving P, Probert C. Biosimilars: what’s around the corner? Frontline Gastroenterology 2015; 6 (4): 262–263.
  20. British Society of Gastroenterology. BSG guidance on the use of biosimilar infliximab CT-P13 in inflammatory bowel disease. BSG, 2016. Available at: www.bsg.org.uk/images/stories/docs/clinical/guidance/bsg_infliximab_guidance_16.pdf 
  21. Danese S, Gomollon F. ECCO position statement: the use of biosimilar medicines in the treatment of inflammatory bowel disease (IBD). J Crohns Colitis 2013; 7 (7): 586–589.
  22. Danese S, Fiorino G, Raine T et al. ECCO position statement on the use of biosimilars for inflammatory bowel disease—an update. J Crohns Colitis 2017; 11 (1): 26–34.
  23. Bridges S, White D, Worthing A et al. The science behind biosimilars. Arthritis Rheumatol 2018; 70 (3): 334–344.

UK/INM-18005a

Date of preparation: May 2018